A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02443155
• Collaborator: (none)
• Enrollment: 308
• Locations: 108
• Arms: 4
• Actual Duration (Months): 39.6
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1	Drug: NNC0114-0006; Drug: liraglutide; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 308 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function
• Actual Study Start Date: Nov 10, 2015
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Feb 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0114-0006 + Liraglutide	Drug: NNC0114-0006; NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment; Drug: liraglutide; Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
Experimental: NNC0114-0006 + Placebo	Drug: NNC0114-0006; NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment; Drug: placebo; Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
Active Comparator: Liraglutide + Placebo	Drug: liraglutide; Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment; Drug: placebo; Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
Placebo Comparator: Placebo	Drug: placebo; Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

Outcome Measures

Primary Outcome Measures

1. Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline [0 - 4 hours post-dose on week 0 and week 54]

   Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).

Secondary Outcome Measures

1. AUC0-2h of C-peptide at Week 54 Relative to Baseline [0-2 hours post-dose on week 0 and week 54]

   Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.

2. Cmax of C-peptide at Week 54 Relative to Baseline [0-4 hours post-dose on week 0 and week 54]

   Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

3. AUC0-4h of Glucose at Week 54 Relative to Baseline [0 - 4 hours post-dose on week 0 and week 54]

   Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).

4. AUC0-2h of Glucose at Week 54 Relative to Baseline [0-2 hours post-dose on week 0 and week 54]

   Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol*h/L'.

5. Cmax of Glucose at Week 54 Relative to Baseline [0-4 hours post-dose on week 0 and week 54]

   Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

6. Number of Treatment Emergent Adverse Events [Week 0-54; Week 54-80]

   An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

7. Number of Treatment Emergent Hyperglycaemic Episodes [Week 0-54; Week 54-80]

   Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

8. Number of Treatment Emergent Episodes of Diabetic Ketoacidosis [Weeks 0-54; Weeks 54-80]

   Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

9. Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion [Week 0-54]

   Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.

10. Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) [Weeks 0-54; Weeks 54-80]

    Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.

11. Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions [Weeks 0-54; Weeks 54-80]

    Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.

12. Change in Body Weight (kg) [(Week 0, week 54) and (week 0, week 80)]

    Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.

13. Diabetes Retinopathy [Baseline, week 54 and week 80]

    Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.

14. Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline [(Week 0, week 54) and (week 0, week 80)]

    The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.

15. Change in Haematology: Erythrocytes [(Week 0, week 54) and (week 0, week 80)]

    Change in erythrocytes (measured in 10^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

16. Change in Haematology: Haematocrit [(Week 0, week 54) and (week 0, week 80)]

    Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

17. Change in Haematology: Haemoglobin [(Week 0, week 54) and (week 0, week 80)]

    Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

18. Change in Haematology: Leukocytes [(Week 0, week 54) and (week 0, week 80)]

    Change in leukocytes (measured in 10^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

19. Change in Haematology: Mean Corpuscular Hemoglobin [(Week 0, week 54) and (week 0, week 80)]

    Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

20. Change in Haematology: Mean Corpuscular Hemoglobin Concentration [(Week 0, week 54) and (week 0, week 80)]

    Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

21. Change in Haematology: Mean Corpuscular Volume [(Week 0, week 54) and (week 0, week 80)]

    Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

22. Change in Haematology: Thrombocytes [(Week 0, week 54) and (week 0, week 80)]

    Change in thrombocytes (measured in 10^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

23. Change in Haematology: Eosinophil [(Week 0, week 54) and (week 0, week 80)]

    Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

24. Change in Haematology: Neutrophils [(Week 0, week 54) and (week 0, week 80)]

    Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

25. Change in Haematology: Basophils [(Week 0, week 54) and (week 0, week 80)]

    Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

26. Change in Haematology: Lymphocytes [(Week 0, week 54) and (week 0, week 80)]

    Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

27. Change in Haematology: Monocytes [(Week 0, week 54) and (week 0, week 80)]

    Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

28. Change in Biochemistry: Alanine Aminotransferase (ALAT) [(Week 0, week 54) and (week 0, week 80)]

    Change in ALAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

29. Change in Biochemistry: Albumin [(Week 0, week 54) and (week 0, week 80)]

    Change in albumin (measured in gram per deciliter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

30. Change in Biochemistry: Amylase [(Week 0, week 54) and (week 0, week 80)]

    Change in amylase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

31. Change in Biochemistry: Alkaline Phosphatase (ALP) [(Week 0, week 54) and (week 0, week 80)]

    Change in ALP (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

32. Change in Biochemistry: Aspartate Aminotransferase (ASAT) [(Week 0, week 54) and (week 0, week 80)]

    Change in ASAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

33. Change in Biochemistry: Total Bilirubin [(Week 0, week 54) and (week 0, week 80)]

    Change in Total bilirubin (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

34. Change in Biochemistry: Calcium Corrected [(Week 0, week 54) and (week 0, week 80)]

    Change in calcium corrected (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

35. Change in Biochemistry: Chloride [(Week 0, week 54) and (week 0, week 80)]

    Change in chloride (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

36. Change in Biochemistry: Creatine Kinase [(Week 0, week 54) and (week 0, week 80)]

    Change in creatine kinase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

37. Change in Biochemistry: Creatinine [(Week 0, week 54) and (week 0, week 80)]

    Change in creatinine (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

38. Change in Biochemistry: Gamma-glutamyl Transferase (GGT) [(Week 0, week 54) and (week 0, week 80)]

    Change in GGT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

39. Change in Biochemistry: C-reactive Protein Serum [(Week 0, week 54) and (week 0, week 80)]

    Change in C-reactive protein serum (measured in milligrams per liter [mg/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

40. Change in Biochemistry: Lactate Dehydrogenase [(Week 0, week 54) and (week 0, week 80)]

    Change in Lactate Dehydrogenase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

41. Change in Biochemistry: Lipase [(Week 0, week 54) and (week 0, week 80)]

    Change in lipase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

42. Change in Biochemistry: Magnesium [(Week 0, week 54) and (week 0, week 80)]

    Change in magnesium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

43. Change in Biochemistry: Phosphate [(Week 0, week 54) and (week 0, week 80)]

    Change in phosphate (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

44. Change in Biochemistry: Potassium [(Week 0, week 54) and (week 0, week 80)]

    Change in potassium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

45. Change in Biochemistry: Sodium [(Week 0, week 54) and (week 0, week 80)]

    Change in sodium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

46. Change in Biochemistry: Total Protein [(Week 0, week 54) and (week 0, week 80)]

    Change in total protein (measured in gram per liter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

47. Change in Biochemistry: Blood Urea Nitrogen Serum [(Week 0, week 54) and (week 0, week 80)]

    Change in blood urea nitrogen serum (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

48. Change in Biochemistry: Uric Acid [(Week 0, week 54) and (week 0, week 80)]

    Change in Uric Acid (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

49. Change in International Normalised Ratio (INR) [(Week 0, week 54) and (week 0, week 80)]

    Change in INR (measured in ratio]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

50. Change in D-Dimer [(Week 0, week 54) and (week 0, week 80)]

    Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

51. Change in Lipids: Total Cholesterol (Ratio to Baseline) [(Week 0, week 54) and (week 0, week 80)]

    Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

52. Change in Lipids: Free Fatty Acids (Ratio to Baseline) [(Week 0, week 54) and (week 0, week 80)]

    Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

53. Change in Lipids: HDL Cholesterol (Ratio to Baseline) [(Week 0, week 54) and (week 0, week 80)]

    Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

54. Change in Lipids: LDL Cholesterol (Ratio to Baseline) [(Week 0, week 54) and (week 0, week 80)]

    Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

55. Change in Lipids: Triglycerides (TG) (Ratio to Baseline) [(Week 0, week 54) and (week 0, week 80)]

    Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

56. Change in Total Immunoglobulin E (IgE) [(Week 0, week 54) and (week 0, week 80)]

    Change in IgE (measured in kilo international units per liter [kIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

57. Change in Urinalysis: Urine Dipsticks [Week 0, week 54 and week 80]

    Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.

58. Change in Cytokines: Interleukin (IL)-6 [Week 0, week 54 and week 80]

    IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

59. Change in Cytokines- Interleukin (IL)-10 [Week 0, week 54 and week 80]

    IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

60. Change in Cytokines: Interleukin (IL)-17 [Week 0, week 54 and week 80]

    IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

61. Change in Cytokines: Interferon (IFN) Gamma [Week 0, week 54 and week 80]

    IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

62. Change in Cytokines: TNF-alpha [Week 0, week 54 and week 80]

    TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

63. Change in Hormone Level: Thyroid Stimulating Hormone (TSH) [(Week 0, week 54) and (week 0, week 80)]

    Change in TSH (measured in milli international units per liter [mIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

64. Change in Hormone Level: Calcitonin [(Week 0, week 54) and (week 0, week 80)]

    Change in Calcitonin (measured in nanogram per liter [ng/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

65. Change in Systolic and Diastolic Blood Pressure [(Week 0, week 54) and (week 0, week 80)]

    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.

66. Change in Pulse [(Week 0, week 54) and (week 0, week 80)]

    Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80

67. Change in Body Temperature [Week 0, week 54) and (week 0, week 80)]

    Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.

68. Change in Respiratory Rate [(Week 0, week 54) and (week 0, week 80)]

    Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.

69. Change in Electrocardiogram (ECG) [Week 0, week 54 and week 80]

    The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.

70. Change in Eye-examination [Week 0, week 54 and week 80]

    Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.

71. Change in Physical Examination [Week 0, week 54 and week 80]

    Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented.

72. Occurrence of Anti-NNC0114-0006 Antibodies [Week 0, week 54 and week 80]

    This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.

73. Occurrence of Anti-liraglutide Antibodies [Week 0, week 54 and week 80]

    This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.

74. Change in Insulin Dose [(Week 0, week 54) and (week 0, week 80)]

    The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.

75. Change in Number of Insulin Injections [(Week 0, week 54) and (week 0, week 80)]

    The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.

76. Number of Weeks Off Bolus Insulin [(Week 0 to week 54) and (week 0 to week 80)]

    The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.

77. Change in HbA1c [(Week 0, week 54) and (week 0, week 80)]

    Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.

78. Change in Fasting Plasma Glucose [(Week 0, week 54) and (week 0, week 80)]

    Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.

79. Change in Fasting C-peptide- Ratio to Baseline [(Week 0, week 54) and (week 0, week 80)]

    Change in fasting C-peptide (measured in nanomole per liter [nmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

80. Change in Fasting Glucagon- Ratio to Baseline [(Week 0, week 54) and (week 0, week 80)]

    Change in fasting glucagon (measured in picogram per milliliter [pg/mL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

81. 7-point SMPG Profiles [Week 54 and Week 80]

    Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.

82. Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner [(Week 0, week 54) and (week 0, week 80)]

    Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.

83. Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) [(Week 0, week 54) and (week 0, week 80)]

    Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.

84. Change in Mean of 7-point Profiles [(Week 0, week 54) and (week 0, week 80)]

    Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.

85. Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) [Week 54 and week 80]

    Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.

86. Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006) [Pre-dose and 1 hour post-dose during week 48 to week 54]

    AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

87. Terminal Half-life (t½) After Last Dose of NNC0114-0006 [Pre-dose and 1 hour post-dose during week 48 to week 80]

    Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

88. Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006) [Pre-dose and 1 hour post-dose during week 48 to week 80]

    The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

89. Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006) [Pre-dose and 1 hour post-dose during week 48 to week 54]

    Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

90. Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006) [Pre-dose and 1 hour post-dose during week 48 to week 80]

    This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.

91. Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006) [Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)]

    Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

92. Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006) [Week 48 (predose)]

    Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

93. Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006) [Week 48 (1 hour post-dose)]

    C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

94. Liraglutide Concentration at Steady State (C Liraglutide) [Week 54 (post-dose)]

    C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.

95. Change in Biomarker: Immune Phenotyping- B Cell Panel [Week 0, week 54 and week 80]

    B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative.

96. Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel [Week 0, week 54 and week 80]

    NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation.

97. Change in Biomarker: Immune Phenotyping- T Cell Panel [Week 0, week 54 and week 80]

    T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells.

98. Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel [Week 0, week 54 and week 80]

    TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains.

99. Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel [Week 0, week 54 and week 80]

    Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE_MDSC refers to Immature myeloid cells & a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population.

100. Autoantibodies Against Glutamic Acid Decarboxylase (GAD) [Week 0, week 54 and week 80]

     Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive.

101. Autoantibodies Against Zinc-transporter 8 (ZnT8) [Week 0, week 54 and week 80]

     Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.

102. Autoantibodies Against Islet Antigen-2 (IA2) [Week 0, week 54 and week 80]

     Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.

103. Autoantibodies Against Insulin Autoantibodies (IAA) [Week 0, week 54 and week 80]

     Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.

104. Change in Biomarker: Total Interleukin-21 (IL-21) [Week 0, week 54 and week 80]

     IL-21 is evaluated at baseline (week 0), week 54 and week 80.

105. Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) [Week 0, week 54 and week 80]

     Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.

106. Change in Short Form 36 Health Survey (SF-36) [(Week 0, week 54) and (week 0, week 80)]

     SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.

107. Change in Experience of Treatment Benefits and Barriers (ETBB) [(Week 0, week 54) and (week 0, week 80)]

     Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.

108. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) [(Week 0, week 54) and (week 0, week 80)]

     Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.

109. Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline [0 - 4 hours post-dose on week 0 and week 80]

     Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).

110. AUC0-2h of C-peptide at Week 80 Relative to Baseline [0-2 hours post-dose on week 0 and week 80]

     Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.

111. Cmax of C-peptide at Week 80 Relative to Baseline [0-4 hours post-dose on week 0 and week 80]

     Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

112. AUC0-4h of Glucose at Week 80 Relative to Baseline [0 - 4 hours post-dose on week 0 and week 80]

     Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).

113. AUC0-2h of Glucose at Week 80 Relative to Baseline [0-2 hours post-dose on week 0 and week 80]

     Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol*h/L'.

114. Cmax of Glucose at Week 80 Relative to Baseline [0-4 hours post-dose on week 0 and week 80]

     Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

• T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form

• Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2

• BMI (body mass index) higher or equal to 18.5 kg/m^2

• Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening

• Insulin dependence unless in temporary spontaneous remission (honeymoon period)

Exclusion Criteria:

• Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)

• History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)

• History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy

• Vaccination within 4 weeks before randomisation, Visit 3 (V3)

• Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)

• History of pancreatitis (acute or chronic)

• Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

• Any past or current diagnosis of malignant neoplasms

• Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	La Jolla	California	United States	92037
2	Novo Nordisk Investigational Site	Northridge	California	United States	91325
3	Novo Nordisk Investigational Site	Aurora	Colorado	United States	80045
4	Novo Nordisk Investigational Site	Miami	Florida	United States	33136
5	Novo Nordisk Investigational Site	Orlando	Florida	United States	32804
6	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30318
7	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
8	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89128
9	Novo Nordisk Investigational Site	Teaneck	New Jersey	United States	07666
10	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27517
11	Novo Nordisk Investigational Site	Nashville	Tennessee	United States	37203
12	Novo Nordisk Investigational Site	Houston	Texas	United States	77079
13	Novo Nordisk Investigational Site	Mesquite	Texas	United States	75149
14	Novo Nordisk Investigational Site	Graz		Austria	8036
15	Novo Nordisk Investigational Site	Innsbruck		Austria	6020
16	Novo Nordisk Investigational Site	Salzburg		Austria	5020
17	Novo Nordisk Investigational Site	Wien		Austria	1030
18	Novo Nordisk Investigational Site	Wien		Austria	1130
19	Novo Nordisk Investigational Site	Brussel		Belgium	1090
20	Novo Nordisk Investigational Site	Edegem		Belgium	2650
21	Novo Nordisk Investigational Site	Leuven		Belgium	3000
22	Novo Nordisk Investigational Site	Edmonton	Alberta	Canada	T6G 2E1
23	Novo Nordisk Investigational Site	Vancouver	British Columbia	Canada	V5Z 1M9
24	Novo Nordisk Investigational Site	Winnipeg	Manitoba	Canada	R3E 3P4
25	Novo Nordisk Investigational Site	Halifax	Nova Scotia	Canada	B3H 2Y9
26	Novo Nordisk Investigational Site	Kingston	Ontario	Canada	K7L 2V7
27	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M4G 3E8
28	Novo Nordisk Investigational Site	Laval	Quebec	Canada	H7T 2P5
29	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H4A 3T2
30	Novo Nordisk Investigational Site	PQ	Quebec	Canada	G1L 3L5
31	Novo Nordisk Investigational Site	Sherbrooke	Quebec	Canada	J1H 5N4
32	Novo Nordisk Investigational Site	Aarhus N		Denmark	8200
33	Novo Nordisk Investigational Site	Esbjerg		Denmark	6700
34	Novo Nordisk Investigational Site	Hellerup		Denmark	2900
35	Novo Nordisk Investigational Site	Helsinki		Finland	00290
36	Novo Nordisk Investigational Site	Oulu		Finland	90220
37	Novo Nordisk Investigational Site	Tampere		Finland	33520
38	Novo Nordisk Investigational Site	Dublin		Ireland	DUBLIN 15
39	Novo Nordisk Investigational Site	Dublin		Ireland	DUBLIN 4
40	Novo Nordisk Investigational Site	Galway		Ireland	H91 YR71
41	Novo Nordisk Investigational Site	Holon		Israel	58100
42	Novo Nordisk Investigational Site	Jerusalem		Israel	91120
43	Novo Nordisk Investigational Site	Petah Tikva		Israel	49202
44	Novo Nordisk Investigational Site	Rehovot		Israel	76100
45	Novo Nordisk Investigational Site	Bergamo		Italy	24127
46	Novo Nordisk Investigational Site	Catanzaro		Italy	88100
47	Novo Nordisk Investigational Site	Milano		Italy	20132
48	Novo Nordisk Investigational Site	Siena		Italy	53100
49	Novo Nordisk Investigational Site	Oslo		Norway	0586
50	Novo Nordisk Investigational Site	Stavanger		Norway	4011
51	Novo Nordisk Investigational Site	Gdansk		Poland	80-214
52	Novo Nordisk Investigational Site	Gdansk		Poland	80-546
53	Novo Nordisk Investigational Site	Warszawa		Poland	04-736
54	Novo Nordisk Investigational Site	Zabrze		Poland	41-800
55	Novo Nordisk Investigational Site	Almada		Portugal	2805-267
56	Novo Nordisk Investigational Site	Amadora		Portugal	2720-276
57	Novo Nordisk Investigational Site	Braga		Portugal	4710-243
58	Novo Nordisk Investigational Site	Matosinhos		Portugal	4464-513
59	Novo Nordisk Investigational Site	Porto		Portugal	4200-319
60	Novo Nordisk Investigational Site	Viana do Castelo		Portugal	4901-858
61	Novo Nordisk Investigational Site	Arkhangelsk		Russian Federation	163001
62	Novo Nordisk Investigational Site	Chelyabinsk		Russian Federation	454048
63	Novo Nordisk Investigational Site	Dzerzhinskiy		Russian Federation	140091
64	Novo Nordisk Investigational Site	Kazan		Russian Federation	420012
65	Novo Nordisk Investigational Site	Moscow		Russian Federation	123423
66	Novo Nordisk Investigational Site	Moscow		Russian Federation	125315
67	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630091
68	Novo Nordisk Investigational Site	Penza		Russian Federation	440026
69	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	199226
70	Novo Nordisk Investigational Site	Saratov		Russian Federation	410031
71	Novo Nordisk Investigational Site	Saratov		Russian Federation	410053
72	Novo Nordisk Investigational Site	Syktyvkar		Russian Federation	167981
73	Novo Nordisk Investigational Site	Ulianovsk		Russian Federation	432063
74	Novo Nordisk Investigational Site	Yoshkar-Ola		Russian Federation	424004
75	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
76	Novo Nordisk Investigational Site	Kragujevac		Serbia	34000
77	Novo Nordisk Investigational Site	Barcelona		Spain	08035
78	Novo Nordisk Investigational Site	Girona		Spain	17007
79	Novo Nordisk Investigational Site	Málaga		Spain	29010
80	Novo Nordisk Investigational Site	Palma de Mallorca		Spain	07198
81	Novo Nordisk Investigational Site	Sabadell		Spain	08208
82	Novo Nordisk Investigational Site	Sevilla		Spain	41003
83	Novo Nordisk Investigational Site	Sevilla		Spain	41009
84	Novo Nordisk Investigational Site	Valencia		Spain	46026
85	Novo Nordisk Investigational Site	Göteborg		Sweden	413 45
86	Novo Nordisk Investigational Site	Karlstad		Sweden	651 85
87	Novo Nordisk Investigational Site	Lund		Sweden	221 85
88	Novo Nordisk Investigational Site	Stockholm		Sweden	141 86
89	Novo Nordisk Investigational Site	Kyiv		Ukraine	02091
90	Novo Nordisk Investigational Site	Kyiv		Ukraine	02232
91	Novo Nordisk Investigational Site	Kyiv		Ukraine	03049
92	Novo Nordisk Investigational Site	Kyiv		Ukraine	04053
93	Novo Nordisk Investigational Site	Kyiv		Ukraine	04114
94	Novo Nordisk Investigational Site	Vinnytsia		Ukraine	21010
95	Novo Nordisk Investigational Site	Zhytomyr		Ukraine	10002
96	Novo Nordisk Investigational Site	Belfast		United Kingdom	BT12 6BA
97	Novo Nordisk Investigational Site	Blackburn		United Kingdom	BB2 3HH
98	Novo Nordisk Investigational Site	Bristol		United Kingdom	BS10 5NB
99	Novo Nordisk Investigational Site	Cardiff		United Kingdom	CF14 4XW
100	Novo Nordisk Investigational Site	Chester		United Kingdom	CH2 1UL
101	Novo Nordisk Investigational Site	Edgbaston, Birmingham		United Kingdom	B15 2TH
102	Novo Nordisk Investigational Site	London		United Kingdom	E1 2AT
103	Novo Nordisk Investigational Site	London		United Kingdom	W2 1NY
104	Novo Nordisk Investigational Site	Newcastle upon Tyne		United Kingdom	NE1 4LP
105	Novo Nordisk Investigational Site	Plymouth		United Kingdom	PL8 8DQ
106	Novo Nordisk Investigational Site	Sheffield		United Kingdom	S5 7AU
107	Novo Nordisk Investigational Site	Stevenage		United Kingdom	SG1 4AB
108	Novo Nordisk Investigational Site	Swansea		United Kingdom	SA2 8PP

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

• Study Protocol - Sep 17, 2019
• Statistical Analysis Plan - Sep 17, 2019

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02443155
• Other Study ID Numbers: NN9828-4150; 2014-001215-39; U1111-1154-7172; REec-2015-1768
• First Posted: May 13, 2015
• Last Update Posted: Apr 9, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Liraglutide

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 94 sites in Austria, Belgium, Canada, Denmark, Finland, Ireland, Israel, Italy, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Ukraine, the United Kingdom (UK), and the United States (US).
Pre-assignment Detail	Participants were randomised in a 1:1:1:1 manner to one of the four treatment groups. One participant was randomised to liraglutide arm but was withdrawn from the trial before exposure to trial products as per investigator's decision.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Period Title: Overall Study
STARTED	77	77	76	77
Full Analysis Set	77	77	76	77
PK Analysis Set	21	21	22	20
Safety Analysis Set	77	77	76	77
COMPLETED	65	63	67	61
NOT COMPLETED	12	14	9	16

Baseline Characteristics

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)	Total
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Total of all reporting groups
Overall Participants	77	77	76	77	307
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.0 (7.5)	28.6 (7.9)	28.0 (7.1)	29.0 (7.0)	28.4 (7.3)
Sex: Female, Male (Count of Participants)
Female	21 27.3%	32 41.6%	25 32.9%	28 36.4%	106 34.5%
Male	56 72.7%	45 58.4%	51 67.1%	49 63.6%	201 65.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 5.2%	3 3.9%	2 2.6%	1 1.3%	10 3.3%
Not Hispanic or Latino	73 94.8%	74 96.1%	74 97.4%	76 98.7%	297 96.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 1.3%	0 0%	0 0%	1 0.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	2 2.6%	1 1.3%	1 1.3%	4 1.3%
White	73 94.8%	70 90.9%	73 96.1%	76 98.7%	292 95.1%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	4 5.2%	4 5.2%	2 2.6%	0 0%	10 3.3%

Outcome Measures

1. Primary Outcome

Title	Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).
Time Frame	0 - 4 hours post-dose on week 0 and week 54

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	66	65	68	63
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	0.934 (61.9)	0.783 (45.5)	0.709 (104.8)	0.660 (86.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NNC0114-0006 + Liraglutide (Experimental), Placebo (Placebo)
	Comments	Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.0017
	Comments
	Method	Mixed model repeated measurements
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	1.48
	Confidence Interval	(2-Sided) 95%; 1.16 to 1.89
	Parameter Dispersion	Type: Value:
	Estimation Comments	NNC0114-0006 + liraglutide / Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NNC0114-0006 (Experimental), Placebo (Placebo)
	Comments	Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.0927
	Comments
	Method	Mixed model repeated measurements
	Comments
Method of Estimation	Estimation Parameter	Treatment Ratio
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Liraglutide (Experimental), Placebo (Placebo)
	Comments	Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.3780
	Comments
	Method	Mixed model repeated measurements
	Comments
Method of Estimation	Estimation Parameter	Treatment Ratio
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	NNC0114-0006 + Liraglutide (Experimental), NNC0114-0006 (Experimental)
	Comments	Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.1377
	Comments
	Method	Mixed model repeated measurements
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	1.20
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	NNC0114-0006 + Liraglutide (Experimental), Liraglutide (Experimental)
	Comments	Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.0214
	Comments
	Method	Mixed model repeated measurements
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95%; 1.04 to 1.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	NNC0114-0006 (Experimental), Liraglutide (Experimental)
	Comments	Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.4187
	Comments
	Method	Mixed model repeated measurements
	Comments
Method of Estimation	Estimation Parameter	Treatmrnt ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	AUC0-2h of C-peptide at Week 54 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.
Time Frame	0-2 hours post-dose on week 0 and week 54

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	66	65	68	63
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	0.961 (65.4)	0.824 (53.0)	0.646 (97.4)	0.655 (87.3)

3. Secondary Outcome

Title	Cmax of C-peptide at Week 54 Relative to Baseline
Description	Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).
Time Frame	0-4 hours post-dose on week 0 and week 54

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	66	65	68	63
Geometric Mean (Geometric Coefficient of Variation) [Ratio of Cmax]	0.978 (70.3)	0.779 (47.6)	0.733 (110.4)	0.644 (89.4)

4. Secondary Outcome

Title	AUC0-4h of Glucose at Week 54 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).
Time Frame	0 - 4 hours post-dose on week 0 and week 54

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	65	65	67	62
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	0.904 (33.1)	1.078 (31.8)	0.993 (34.2)	1.089 (36.7)

5. Secondary Outcome

Title	AUC0-2h of Glucose at Week 54 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol*h/L'.
Time Frame	0-2 hours post-dose on week 0 and week 54

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	65	65	67	62
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	0.939 (28.5)	1.066 (24.8)	0.978 (31.9)	1.057 (31.3)

6. Secondary Outcome

Title	Cmax of Glucose at Week 54 Relative to Baseline
Description	Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.
Time Frame	0-4 hours post-dose on week 0 and week 54

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	65	65	67	62
Geometric Mean (Geometric Coefficient of Variation) [Ratio of Cmax]	0.937 (27.8)	1.068 (25.4)	1.004 (29.1)	1.057 (30.9)

7. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events
Description	An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Time Frame	Week 0-54; Week 54-80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0-54	434	327	410	364
Week 54-80	70	73	78	87

8. Secondary Outcome

Title	Number of Treatment Emergent Hyperglycaemic Episodes
Description	Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Time Frame	Week 0-54; Week 54-80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0-54	302	256	217	291
Week 54-80	306	74	352	112

9. Secondary Outcome

Title	Number of Treatment Emergent Episodes of Diabetic Ketoacidosis
Description	Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Time Frame	Weeks 0-54; Weeks 54-80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0-54	0	0	0	0
Week 54-80	0	0	1	1

10. Secondary Outcome

Title	Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion
Description	Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.
Time Frame	Week 0-54

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Count of Participants [Participants]	2 2.6%	0 0%	0 0%	1 1.3%

11. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)
Description	Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.
Time Frame	Weeks 0-54; Weeks 54-80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Severe hypoglycaemia (Week 0-54)	1	2	0	0
Asymptomatic hypoglycaemia (Week 0-54)	2038	1956	2092	1774
Documented symptomatic hypoglycaemia (Week 0-54)	1305	1461	1114	1625
Pseudo-hypoglycaemia (Week 0-54)	1	1	14	2
Probable symptomatic hypoglycaemia (Week 0-54)	9	0	4	10
Severe hypoglycaemia (Week 54-80)	3	1	0	1
Asymptomatic hypoglycaemia (Week 54-80)	609	522	670	449
Documented symptomatic hypoglycaemia (Week 54-80)	514	362	651	527
Pseudo-hypoglycaemia (Week 54-80)	0	0	1	2
Probable symptomatic hypoglycaemia (Week 54-80)	1	0	0	2

12. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions
Description	Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Time Frame	Weeks 0-54; Weeks 54-80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Severe or BG confirmed (Week 0-54)	396	394	315	503
Symptomatic BG confirmed (Week 0-54)	576	616	479	646
Severe or BG confirmed (Week 54-80)	216	130	244	240
Symptomatic BG confirmed (Week 54-80)	368	207	332	292

13. Secondary Outcome

Title	Change in Body Weight (kg)
Description	Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	-1.8 (4.2)	1.2 (5.0)	-2.5 (4.0)	1.1 (6.1)
Change from week 0 to week 80	1.9 (4.6)	1.6 (5.2)	0.4 (4.7)	2.8 (5.5)

14. Secondary Outcome

Title	Diabetes Retinopathy
Description	Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.
Time Frame	Baseline, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Yes	4 5.2%	2 2.6%	1 1.3%	1 1.3%
No	73 94.8%	75 97.4%	75 98.7%	76 98.7%
Unknown	0 0%	0 0%	0 0%	0 0%
Yes	3 3.9%	2 2.6%	1 1.3%	0 0%
No	65 84.4%	63 81.8%	68 89.5%	68 88.3%
Unknown	0 0%	0 0%	0 0%	0 0%
Yes	3 3.9%	2 2.6%	1 1.3%	0 0%
No	65 84.4%	62 80.5%	67 88.2%	63 81.8%
Unknown	1 1.3%	1 1.3%	1 1.3%	1 1.3%

15. Secondary Outcome

Title	Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline
Description	The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.98 (10.3)	0.95 (8.2)	0.97 (10.2)	1.00 (8.8)
Change from week 0 to week 80	0.97 (9.3)	0.94 (11.4)	0.96 (11.5)	0.99 (10.9)

16. Secondary Outcome

Title	Change in Haematology: Erythrocytes
Description	Change in erythrocytes (measured in 10^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (6.00)	1.01 (6.3)	0.99 (7.2)	1.00 (6.0)
Change from week 0 to week 80	0.99 (6.7)	1.00 (6.7)	0.99 (7.00)	1.00 (5.5)

17. Secondary Outcome

Title	Change in Haematology: Haematocrit
Description	Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (6.6)	1.00 (7.00)	0.99 (7.8)	1.00 (5.9)
Change from week 0 to week 80	0.98 (7.5)	1.00 (7.3)	0.98 (7.2)	0.99 (5.8)

18. Secondary Outcome

Title	Change in Haematology: Haemoglobin
Description	Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.01 (6.1)	1.02 (7.2)	1.00 (7.9)	1.01 (5.6)
Change from week 0 to week 80	1.00 (7.5)	1.02 (8.2)	1.00 (7.4)	1.01 (5.6)

19. Secondary Outcome

Title	Change in Haematology: Leukocytes
Description	Change in leukocytes (measured in 10^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.96 (27.1)	0.98 (21.9)	0.97 (23.2)	1.02 (24.8)
Change from week 0 to week 80	0.99 (33.0)	0.95 (19.9)	0.99 (29.5)	1.00 (24.9)

20. Secondary Outcome

Title	Change in Haematology: Mean Corpuscular Hemoglobin
Description	Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.02 (3.6)	1.01 (4.8)	1.01 (4.0)	1.01 (4.1)
Change from week 0 to week 80	1.02 (5.1)	1.01 (6.6)	1.01 (5.4)	1.02 (4.3)

21. Secondary Outcome

Title	Change in Haematology: Mean Corpuscular Hemoglobin Concentration
Description	Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.02 (2.9)	1.01 (2.1)	1.02 (2.6)	1.02 (3.0)
Change from week 0 to week 80	1.02 (3.5)	1.02 (3.1)	1.02 (3.0)	1.02 (0.29)

22. Secondary Outcome

Title	Change in Haematology: Mean Corpuscular Volume
Description	Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.00 (2.8)	0.99 (3.8)	1.00 (3.3)	0.99 (3.3)
Change from week 0 to week 80	1.00 (4.3)	1.00 (5.2)	1.00 (4.3)	0.99 (3.7)

23. Secondary Outcome

Title	Change in Haematology: Thrombocytes
Description	Change in thrombocytes (measured in 10^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.98 (14.5)	0.98 (15.0)	1.03 (13.2)	0.98 (14.1)
Change from week 0 to week 80	1.00 (15.0)	1.03 (15.7)	1.04 (15.6)	1.00 (17.3)

24. Secondary Outcome

Title	Change in Haematology: Eosinophil
Description	Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.15 (0.65)	1.30 (1.71)	3.10 (13.79)	1.37 (1.15)
Change from week 0 to week 80	1.31 (1.24)	1.23 (1.03)	1.54 (1.78)	1.36 (1.27)

25. Secondary Outcome

Title	Change in Haematology: Neutrophils
Description	Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.98 (18.8)	0.99 (17.6)	0.97 (18.5)	1.04 (17.8)
Change from week 0 to week 80	0.97 (17.5)	0.99 (14.2)	0.98 (20.7)	1.04 (17.2)

26. Secondary Outcome

Title	Change in Haematology: Basophils
Description	Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.73 (2.11)	1.58 (1.52)	1.52 (1.47)	1.43 (1.06)
Change from week 0 to week 80	2.17 (2.17)	1.73 (1.41)	2.09 (1.86)	1.96 (1.27)

27. Secondary Outcome

Title	Change in Haematology: Lymphocytes
Description	Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.00 (28.5)	1.00 (28.3)	1.02 (28.4)	0.91 (30.7)
Change from week 0 to week 80	1.01 (28.0)	0.98 (21.8)	0.99 (35.1)	0.91 (30.6)

28. Secondary Outcome

Title	Change in Haematology: Monocytes
Description	Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.05 (40.8)	1.02 (34.8)	1.01 (41.1)	1.01 (34.9)
Change from week 0 to week 80	1.12 (44.0)	1.07 (37.5)	1.04 (42.9)	1.12 (35.4)

29. Secondary Outcome

Title	Change in Biochemistry: Alanine Aminotransferase (ALAT)
Description	Change in ALAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.96 (47.7)	0.98 (35.9)	0.97 (46.0)	0.90 (44.1)
Change from week 0 to week 80	0.95 (54.7)	0.98 (39.5)	1.06 (40.7)	0.92 (40.6)

30. Secondary Outcome

Title	Change in Biochemistry: Albumin
Description	Change in albumin (measured in gram per deciliter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (7.3)	1.00 (6.00)	1.02 (7.4)	0.99 (7.5)
Change from week 0 to week 80	1.00 (6.7)	1.01 (6.9)	1.00 (6.7)	0.99 (6.9)

31. Secondary Outcome

Title	Change in Biochemistry: Amylase
Description	Change in amylase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.07 (20.7)	0.98 (16.6)	1.04 (18.9)	1.01 (19.2)
Change from week 0 to week 80	1.04 (24.3)	0.99 (14.9)	1.03 (19.8)	1.04 (26.1)

32. Secondary Outcome

Title	Change in Biochemistry: Alkaline Phosphatase (ALP)
Description	Change in ALP (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.03 (28.6)	0.99 (17.8)	0.99 (18.1)	1.03 (17.9)
Change from week 0 to week 80	1.07 (30.3)	1.05 (16.5)	1.04 (22.1)	1.04 (21.7)

33. Secondary Outcome

Title	Change in Biochemistry: Aspartate Aminotransferase (ASAT)
Description	Change in ASAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (39.3)	0.99 (34.5)	1.00 (57.0)	0.98 (43.1)
Change from week 0 to week 80	0.98 (39.1)	0.98 (32.4)	1.09 (34.6)	0.99 (39.3)

34. Secondary Outcome

Title	Change in Biochemistry: Total Bilirubin
Description	Change in Total bilirubin (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.81 (61.7)	1.10 (56.5)	0.99 (49.8)	1.01 (59.4)
Change from week 0 to week 80	0.91 (44.7)	1.04 (74.8)	0.98 (55.1)	0.99 (58.7)

35. Secondary Outcome

Title	Change in Biochemistry: Calcium Corrected
Description	Change in calcium corrected (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (3.7)	0.98 (3.6)	0.98 (4.0)	0.99 (4.2)
Change from week 0 to week 80	0.96 (3.5)	0.97 (4.0)	0.98 (3.9)	0.98 (4.0)

36. Secondary Outcome

Title	Change in Biochemistry: Chloride
Description	Change in chloride (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.01 (2.4)	1.00 (2.2)	1.00 (2.8)	1.00 (3.1)
Change from week 0 to week 80	1.00 (2.3)	1.01 (2.7)	1.00 (3.0)	1.00 (3.0)

37. Secondary Outcome

Title	Change in Biochemistry: Creatine Kinase
Description	Change in creatine kinase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.16 (86.3)	1.17 (64.5)	1.08 (140.2)	1.02 (72.8)
Change from week 0 to week 80	1.11 (48.1)	1.09 (68.3)	1.24 (87.2)	1.13 (76.5)

38. Secondary Outcome

Title	Change in Biochemistry: Creatinine
Description	Change in creatinine (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.01 (12.0)	1.05 (10.6)	1.04 (12.8)	1.01 (9.9)
Change from week 0 to week 80	1.02 (11.2)	1.05 (14.3)	1.05 (13.1)	1.02 (12.3)

39. Secondary Outcome

Title	Change in Biochemistry: Gamma-glutamyl Transferase (GGT)
Description	Change in GGT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.02 (38.6)	1.08 (27.7)	1.03 (37.2)	1.02 (41.8)
Change from week 0 to week 80	1.05 (41.9)	1.13 (29.4)	1.10 (41.1)	1.00 (36.8)

40. Secondary Outcome

Title	Change in Biochemistry: C-reactive Protein Serum
Description	Change in C-reactive protein serum (measured in milligrams per liter [mg/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.92 (141.6)	1.04 (93.0)	0.89 (87.8)	1.06 (78.0)
Change from week 0 to week 80	1.08 (103.8)	0.94 (81.0)	1.25 (134.7)	1.06 (70.1)

41. Secondary Outcome

Title	Change in Biochemistry: Lactate Dehydrogenase
Description	Change in Lactate Dehydrogenase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (12.6)	1.03 (18.4)	1.04 (23.3)	1.03 (16.5)
Change from week 0 to week 80	1.02 (12.1)	1.04 (19.6)	1.09 (19.3)	1.03 (17.8)

42. Secondary Outcome

Title	Change in Biochemistry: Lipase
Description	Change in lipase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.49 (36.6)	1.00 (27.4)	1.34 (36.2)	1.01 (29.4)
Change from week 0 to week 80	1.05 (40.4)	0.94 (27.2)	1.02 (26.5)	0.96 (37.2)

43. Secondary Outcome

Title	Change in Biochemistry: Magnesium
Description	Change in magnesium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.02 (8.9)	1.01 (7.6)	1.02 (7.8)	0.99 (8.1)
Change from week 0 to week 80	1.01 (10.7)	1.03 (11.2)	1.02 (9.0)	0.98 (9.2)

44. Secondary Outcome

Title	Change in Biochemistry: Phosphate
Description	Change in phosphate (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (16.0)	0.99 (16.6)	1.02 (13.9)	0.96 (18.6)
Change from week 0 to week 80	1.02 (20.5)	1.01 (16.9)	1.03 (19.9)	0.99 (17.4)

45. Secondary Outcome

Title	Change in Biochemistry: Potassium
Description	Change in potassium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.01 (8.1)	0.98 (6.9)	0.99 (8.3)	0.98 (10.4)
Change from week 0 to week 80	0.99 (8.3)	0.99 (6.9)	0.98 (8.5)	0.98 (10.0)

46. Secondary Outcome

Title	Change in Biochemistry: Sodium
Description	Change in sodium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.00 (1.9)	1.00 (1.4)	1.00 (1.9)	1.00 (2.0)
Change from week 0 to week 80	0.99 (1.8)	1.00 (2.1)	1.00 (2.3)	1.00 (1.8)

47. Secondary Outcome

Title	Change in Biochemistry: Total Protein
Description	Change in total protein (measured in gram per liter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.99 (6.8)	1.00 (6.0)	1.01 (7.2)	1.00 (7.6)
Change from week 0 to week 80	0.99 (6.5)	1.00 (6.4)	1.00 (6.6)	1.00 (7.4)

48. Secondary Outcome

Title	Change in Biochemistry: Blood Urea Nitrogen Serum
Description	Change in blood urea nitrogen serum (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.00 (27.0)	1.05 (22.4)	0.98 (22.0)	0.94 (23.3)
Change from week 0 to week 80	0.97 (33.2)	0.97 (26.2)	0.98 (28.9)	0.97 (28.2)

49. Secondary Outcome

Title	Change in Biochemistry: Uric Acid
Description	Change in Uric Acid (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.93 (21.3)	0.98 (17.6)	0.98 (18.8)	0.96 (18.0)
Change from week 0 to week 80	0.95 (17.1)	0.94 (19.1)	0.96 (22.2)	0.95 (19.6)

50. Secondary Outcome

Title	Change in International Normalised Ratio (INR)
Description	Change in INR (measured in ratio]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.97 (9.5)	0.96 (10.4)	0.95 (9.8)	0.96 (13.7)
Change from week 0 to week 80	0.98 (12.4)	0.99 (12.9)	0.96 (9.2)	0.97 (11.5)

51. Secondary Outcome

Title	Change in D-Dimer
Description	Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.96 (37.6)	0.98 (53.9)	0.98 (56.8)	1.15 (107.1)
Change from week 0 to week 80	0.96 (43.7)	0.92 (61.3)	1.05 (60.0)	1.10 (74.3)

52. Secondary Outcome

Title	Change in Lipids: Total Cholesterol (Ratio to Baseline)
Description	Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.00 (13.8)	1.02 (14.1)	1.03 (16.2)	1.04 (16.8)
Change from week 0 to week 80	1.02 (15.5)	1.03 (14.1)	1.07 (15.0)	1.03 (18.4)

53. Secondary Outcome

Title	Change in Lipids: Free Fatty Acids (Ratio to Baseline)
Description	Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.86 (94.5)	1.01 (114.4)	1.18 (82.5)	0.97 (68.7)
Change from week 0 to week 80	0.89 (85.3)	1.06 (112.8)	1.19 (92.8)	0.94 (84.0)

54. Secondary Outcome

Title	Change in Lipids: HDL Cholesterol (Ratio to Baseline)
Description	Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.04 (17.3)	1.08 (18.2)	1.12 (19.6)	1.10 (20.2)
Change from week 0 to week 80	1.04 (18.7)	1.06 (16.7)	1.14 (21.5)	1.07 (22.2)

55. Secondary Outcome

Title	Change in Lipids: LDL Cholesterol (Ratio to Baseline)
Description	Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.96 (17.8)	0.97 (20.9)	0.98 (24.0)	1.01 (23.6)
Change from week 0 to week 80	0.99 (22.2)	1.02 (21.2)	1.02 (21.2)	1.03 (29.2)

56. Secondary Outcome

Title	Change in Lipids: Triglycerides (TG) (Ratio to Baseline)
Description	Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.03 (46.2)	0.96 (39.5)	1.03 (49.2)	1.02 (54.7)
Change from week 0 to week 80	1.08 (45.6)	0.94 (45.1)	1.09 (51.5)	0.95 (50.4)

57. Secondary Outcome

Title	Change in Total Immunoglobulin E (IgE)
Description	Change in IgE (measured in kilo international units per liter [kIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.31 (71.6)	1.05 (63.1)	1.08 (45.7)	1.02 (41.8)
Change from week 0 to week 80	1.32 (65.4)	1.18 (38.5)	1.16 (55.1)	0.94 (61.2)

58. Secondary Outcome

Title	Change in Urinalysis: Urine Dipsticks
Description	Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Normal	72 93.5%	71 92.2%	67 88.2%	71 92.2%
Abnormal, NCS	5 6.5%	6 7.8%	9 11.8%	6 7.8%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	57 74%	56 72.7%	63 82.9%	59 76.6%
Abnormal, NCS	9 11.7%	9 11.7%	5 6.6%	6 7.8%
Abnormal, CS	2 2.6%	0 0%	0 0%	0 0%
Normal	54 70.1%	54 70.1%	54 71.1%	51 66.2%
Abnormal, NCS	12 15.6%	10 13%	13 17.1%	11 14.3%
Abnormal, CS	0 0%	0 0%	1 1.3%	0 0%
Normal	74 96.1%	73 94.8%	73 96.1%	76 98.7%
Abnormal, NCS	2 2.6%	4 5.2%	3 3.9%	1 1.3%
Abnormal, CS	1 1.3%	0 0%	0 0%	0 0%
Normal	68 88.3%	64 83.1%	65 85.5%	64 83.1%
Abnormal, NCS	0 0%	1 1.3%	3 3.9%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	65 84.4%	61 79.2%	66 86.8%	61 79.2%
Abnormal, NCS	1 1.3%	3 3.9%	1 1.3%	1 1.3%
Abnormal, CS	0 0%	0 0%	1 1.3%	0 0%
Normal	75 97.4%	77 100%	76 100%	75 97.4%
Abnormal, NCS	2 2.6%	0 0%	0 0%	2 2.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	65 84.4%	68 89.5%	64 83.1%
Abnormal, NCS	1 1.3%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	66 85.7%	64 83.1%	68 89.5%	62 80.5%
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	74 96.1%	74 96.1%	74 97.4%	72 93.5%
Abnormal, NCS	2 2.6%	3 3.9%	2 2.6%	4 5.2%
Abnormal, CS	1 1.3%	0 0%	0 0%	1 1.3%
Normal	66 85.7%	63 81.8%	66 86.8%	63 81.8%
Abnormal, NCS	2 2.6%	2 2.6%	2 2.6%	2 2.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	63 81.8%	61 79.2%	65 85.5%	60 77.9%
Abnormal, NCS	3 3.9%	3 3.9%	3 3.9%	2 2.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	77 100%	73 94.8%	76 100%	77 100%
Abnormal, NCS	0 0%	4 5.2%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	64 83.1%	62 80.5%	67 88.2%	64 83.1%
Abnormal, NCS	4 5.2%	3 3.9%	1 1.3%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	62 80.5%	61 79.2%	67 88.2%	60 77.9%
Abnormal, NCS	4 5.2%	3 3.9%	1 1.3%	2 2.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	77 100%	77 100%	76 100%	77 100%
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	68 88.3%	65 84.4%	68 89.5%	65 84.4%
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	65 84.4%	64 83.1%	68 89.5%	61 79.2%
Abnormal, NCS	1 1.3%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	77 100%	71 92.2%	75 98.7%	76 98.7%
Abnormal, NCS	0 0%	6 7.8%	1 1.3%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	64 83.1%	62 81.6%	61 79.2%
Abnormal, NCS	1 1.3%	1 1.3%	6 7.9%	4 5.2%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	63 81.8%	62 80.5%	65 85.5%	59 76.6%
Abnormal, NCS	3 3.9%	1 1.3%	3 3.9%	2 2.6%
Abnormal, CS	0 0%	1 1.3%	0 0%	1 1.3%
Normal	75 97.4%	77 100%	76 100%	75 97.4%
Abnormal, NCS	2 2.6%	0 0%	0 0%	2 2.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	65 84.4%	68 89.5%	64 83.1%
Abnormal, NCS	1 1.3%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	65 84.4%	64 83.1%	68 89.5%	62 80.5%
Abnormal, NCS	1 1.3%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%

59. Secondary Outcome

Title	Change in Cytokines: Interleukin (IL)-6
Description	IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0	0.9 (0.6)	0.8 (0.1)	1.2 (1.8)	0.8 (0.3)
Week 54	0.8 (0.3)	0.8 (0.4)	1.0 (0.8)	0.8 (0.2)
Week 80	0.9 (0.4)	0.8 (0.2)	0.9 (0.8)	0.9 (0.4)

60. Secondary Outcome

Title	Change in Cytokines- Interleukin (IL)-10
Description	IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0	0.7 (1.4)	0.5 (1.1)	0.4 (0.3)	0.4 (0.2)
Week 54	0.4 (0.2)	0.4 (0.1)	0.4 (0.3)	0.4 (0.3)
Week 80	0.4 (0.5)	0.4 (0.2)	0.5 (0.7)	0.4 (0.1)

61. Secondary Outcome

Title	Change in Cytokines: Interleukin (IL)-17
Description	IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0	4.9 (2.0)	4.7 (0.7)	4.7 (0.0)	4.8 (0.9)
Week 54	4.9 (1.9)	4.8 (1.3)	5.1 (3.5)	5.4 (5.0)
Week 80	4.9 (1.7)	4.7 (0.0)	4.8 (1.2)	4.8 (1.0)

62. Secondary Outcome

Title	Change in Cytokines: Interferon (IFN) Gamma
Description	IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0	7.3 (16.1)	7.8 (24.0)	5.8 (11.6)	4.3 (2.8)
Week 54	4.6 (4.2)	7.5 (19.6)	5.0 (6.8)	5.8 (7.0)
Week 80	4.4 (2.8)	4.9 (6.4)	13.0 (57.5)	4.5 (3.4)

63. Secondary Outcome

Title	Change in Cytokines: TNF-alpha
Description	TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0	2.60 (1.69)	2.32 (0.82)	2.70 (1.73)	3.06 (3.75)
Week 54	2.36 (0.75)	2.33 (0.59)	2.56 (1.11)	2.43 (0.65)
Week 80	2.43 (0.66)	2.36 (0.68)	2.96 (2.39)	2.75 (2.47)

64. Secondary Outcome

Title	Change in Hormone Level: Thyroid Stimulating Hormone (TSH)
Description	Change in TSH (measured in milli international units per liter [mIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.00 (49.9)	1.12 (54.1)	0.89 (46.6)	0.91 (66.1)
Change from week 0 to week 80	1.04 (46.7)	0.99 (116.1)	0.99 (48.5)	0.93 (84.5)

65. Secondary Outcome

Title	Change in Hormone Level: Calcitonin
Description	Change in Calcitonin (measured in nanogram per liter [ng/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	1.00 (43.5)	0.90 (48.5)	0.89 (57.2)	0.88 (47.4)
Change from week 0 to week 80	0.85 (50.9)	0.93 (41.8)	0.82 (71.5)	0.90 (64.5)

66. Secondary Outcome

Title	Change in Systolic and Diastolic Blood Pressure
Description	Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 54: Systolic blood pressure	-3 (9)	3 (9)	-2 (14)	1 (11)
Week 80: Systolic blood pressure	-1 (10)	2 (11)	1 (12)	4 (10)
Week 54: Diastolic blood pressure	-0 (9)	2 (9)	-1 (10)	-1 (8)
Week 80: Diastolic blood pressure	-0 (9)	2 (9)	1 (10)	1 (10)

67. Secondary Outcome

Title	Change in Pulse
Description	Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	3 (12)	0 (12)	6 (9)	2 (8)
Change from week 0 to week 80	-1 (10)	-1 (10)	2 (10)	1 (9)

68. Secondary Outcome

Title	Change in Body Temperature
Description	Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.
Time Frame	Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	-0.1 (0.4)	0.0 (0.6)	-0.1 (0.5)	-0.0 (0.3)
Change from week 0 to week 80	-0.0 (0.4)	0.1 (0.5)	0.0 (0.5)	0.0 (0.4)

69. Secondary Outcome

Title	Change in Respiratory Rate
Description	Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	-0.3 (2.2)	0.1 (3.0)	0.1 (2.5)	0.6 (2.4)
Change from week 0 to week 80	-0.3 (2.0)	-0.2 (2.7)	0.1 (2.5)	0.1 (2.2)

70. Secondary Outcome

Title	Change in Electrocardiogram (ECG)
Description	The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Normal	62 80.5%	65 84.4%	60 78.9%	63 81.8%
Abnormal, NCS	15 19.5%	12 15.6%	16 21.1%	13 16.9%
Abnormal, CS	0 0%	0 0%	0 0%	1 1.3%
Normal	54 70.1%	48 62.3%	55 72.4%	46 59.7%
Abnormal, NCS	14 18.2%	17 22.1%	12 15.8%	19 24.7%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	51 66.2%	48 62.3%	53 69.7%	50 64.9%
Abnormal, NCS	15 19.5%	16 20.8%	15 19.7%	12 15.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%

71. Secondary Outcome

Title	Change in Eye-examination
Description	Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Normal	64 83.1%	68 88.3%	70 92.1%	66 85.7%
Abnormal, NCS	13 16.9%	9 11.7%	6 7.9%	11 14.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	55 71.4%	56 72.7%	60 78.9%	54 70.1%
Abnormal, NCS	12 15.6%	7 9.1%	9 11.8%	9 11.7%
Abnormal, CS	1 1.3%	0 0%	0 0%	1 1.3%
Normal	52 67.5%	54 70.1%	59 77.6%	51 66.2%
Abnormal, NCS	11 14.3%	8 10.4%	6 7.9%	8 10.4%
Abnormal, CS	3 3.9%	0 0%	0 0%	0 0%
Normal	58 75.3%	66 85.7%	69 90.8%	67 87%
Abnormal, NCS	18 23.4%	11 14.3%	7 9.2%	10 13%
Abnormal, CS	1 1.3%	0 0%	0 0%	0 0%
Normal	55 71.4%	55 71.4%	60 78.9%	55 71.4%
Abnormal, NCS	13 16.9%	8 10.4%	9 11.8%	8 10.4%
Abnormal, CS	0 0%	0 0%	0 0%	1 1.3%
Normal	52 67.5%	53 68.8%	58 76.3%	51 66.2%
Abnormal, NCS	12 15.6%	9 11.7%	7 9.2%	8 10.4%
Abnormal, CS	2 2.6%	0 0%	0 0%	0 0%

72. Secondary Outcome

Title	Change in Physical Examination
Description	Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Normal	76 98.7%	77 100%	76 100%	76 98.7%
Abnormal, NCS	1 1.3%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	68 88.3%	64 83.1%	66 86.8%	65 84.4%
Abnormal, NCS	0 0%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	1 1.3%	0 0%	0 0%
Normal	67 87%	64 83.1%	68 89.5%	61 79.2%
Abnormal, NCS	0 0%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	75 97.4%	77 100%	76 100%	76 98.7%
Abnormal, NCS	2 2.6%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	66 85.7%	65 84.4%	66 86.8%	66 85.7%
Abnormal, NCS	1 1.3%	0 0%	0 0%	0 0%
Abnormal, CS	1 1.3%	0 0%	0 0%	0 0%
Normal	65 84.4%	64 83.1%	66 86.8%	60 77.9%
Abnormal, NCS	2 2.6%	0 0%	2 2.6%	2 2.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	77 100%	77 100%	76 100%	77 100%
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	68 88.3%	65 84.4%	66 86.8%	66 85.7%
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	64 83.1%	68 89.5%	61 79.2%
Abnormal, NCS	0 0%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	74 96.1%	76 98.7%	76 100%	73 94.8%
Abnormal, NCS	3 3.9%	1 1.3%	0 0%	4 5.2%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	65 84.4%	65 85.5%	66 85.7%
Abnormal, NCS	1 1.3%	0 0%	1 1.3%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	64 83.1%	67 88.2%	62 80.5%
Abnormal, NCS	0 0%	0 0%	1 1.3%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	75 97.4%	76 98.7%	76 100%	76 98.7%
Abnormal, NCS	2 2.6%	1 1.3%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	68 88.3%	64 83.1%	66 86.8%	65 84.4%
Abnormal, NCS	0 0%	1 1.3%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	63 81.8%	68 89.5%	61 79.2%
Abnormal, NCS	0 0%	1 1.3%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	76 98.7%	75 97.4%	74 97.4%	77 100%
Abnormal, NCS	1 1.3%	2 2.6%	2 2.6%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	65 84.4%	63 81.8%	66 86.8%	65 84.4%
Abnormal, NCS	1 1.3%	2 2.6%	0 0%	1 1.3%
Abnormal, CS	2 2.6%	0 0%	0 0%	0 0%
Normal	66 85.7%	64 83.1%	68 89.5%	62 80.5%
Abnormal, NCS	1 1.3%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	77 100%	76 98.7%	76 100%	76 98.7%
Abnormal, NCS	0 0%	1 1.3%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	68 88.3%	64 83.1%	66 86.8%	65 84.4%
Abnormal, NCS	0 0%	1 1.3%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	66 85.7%	63 81.8%	68 89.5%	62 80.5%
Abnormal, NCS	1 1.3%	1 1.3%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	70 90.9%	75 97.4%	69 90.8%	74 96.1%
Abnormal, NCS	6 7.8%	2 2.6%	7 9.2%	3 3.9%
Abnormal, CS	1 1.3%	0 0%	0 0%	0 0%
Normal	61 79.2%	63 81.8%	63 82.9%	66 85.7%
Abnormal, NCS	5 6.5%	1 1.3%	3 3.9%	0 0%
Abnormal, CS	2 2.6%	1 1.3%	0 0%	0 0%
Normal	61 79.2%	62 80.5%	65 85.5%	62 80.5%
Abnormal, NCS	6 7.8%	2 2.6%	3 3.9%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	77 100%	76 98.7%	76 100%	77 100%
Abnormal, NCS	0 0%	1 1.3%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	68 88.3%	65 84.4%	66 86.8%	64 83.1%
Abnormal, NCS	0 0%	0 0%	0 0%	1 1.3%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	63 81.8%	67 88.2%	62 80.5%
Abnormal, NCS	0 0%	0 0%	1 1.3%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	77 100%	76 98.7%	76 100%	75 97.4%
Abnormal, NCS	0 0%	1 1.3%	0 0%	2 2.6%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	65 84.4%	66 86.8%	65 84.4%
Abnormal, NCS	1 1.3%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%
Normal	67 87%	64 83.1%	68 89.5%	62 80.5%
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%
Abnormal, CS	0 0%	0 0%	0 0%	0 0%

73. Secondary Outcome

Title	Occurrence of Anti-NNC0114-0006 Antibodies
Description	This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77
Negative	68 88.3%	62 80.5%
Positive	9 11.7%	14 18.2%
Negative	4 5.2%	7 9.1%
Positive	5 6.5%	7 9.1%
Negative	68 88.3%	62 80.5%
Positive	0 0%	3 3.9%
Negative	0 0%	3 3.9%
Positive	0 0%	0 0%
Negative	65 84.4%	60 77.9%
Positive	2 2.6%	4 5.2%
Negative	1 1.3%	2 2.6%
Positive	1 1.3%	2 2.6%

74. Secondary Outcome

Title	Occurrence of Anti-liraglutide Antibodies
Description	This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	Liraglutide (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	76
Negative	77 100%	75 97.4%
Positive	0 0%	0 0%
Negative	0 0%	0 0%
Positive	0 0%	0 0%
Negative	67 87%	65 84.4%
Positive	1 1.3%	2 2.6%
Negative	1 1.3%	1 1.3%
Positive	0 0%	1 1.3%
Negative	67 87%	66 85.7%
Positive	0 0%	2 2.6%
Negative	0 0%	0 0%
Positive	0 0%	0 0%

75. Secondary Outcome

Title	Change in Insulin Dose
Description	The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	-0.05 (0.18)	0.02 (0.18)	0.01 (0.23)	0.09 (0.19)
Change from week 0 to week 80	0.10 (0.20)	0.05 (0.19)	0.11 (0.22)	0.12 (0.18)

76. Secondary Outcome

Title	Change in Number of Insulin Injections
Description	The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	-0.3 (1.5)	-0.1 (1.2)	-0.5 (1.7)	0.2 (1.4)
Change from week 0 to week 80	0.2 (1.5)	-0.3 (1.3)	-0.2 (1.5)	0.2 (1.3)

77. Secondary Outcome

Title	Number of Weeks Off Bolus Insulin
Description	The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.
Time Frame	(Week 0 to week 54) and (week 0 to week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0 to week 54	10 (18)	5 (14)	9 (18)	4 (11)
Week 0 to week 80	14 (25)	9 (20)	12 (24)	6 (14)

78. Secondary Outcome

Title	Change in HbA1c
Description	Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	-0.7 (1.9)	-0.5 (1.4)	-0.3 (1.5)	-0.3 (1.9)
Change from week 0 to week 80	-0.1 (1.6)	-0.2 (1.5)	0.5 (2.1)	-0.4 (1.8)

79. Secondary Outcome

Title	Change in Fasting Plasma Glucose
Description	Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.5 (3.2)	0.2 (2.4)	-0.3 (3.1)	0.5 (2.4)
Change from week 0 to week 80	1.1 (3.3)	0.3 (2.4)	0.2 (4.0)	1.0 (2.4)

80. Secondary Outcome

Title	Change in Fasting C-peptide- Ratio to Baseline
Description	Change in fasting C-peptide (measured in nanomole per liter [nmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Ratio from week 0 to week 54	1.01 (76.8)	0.70 (71.1)	0.65 (102.4)	0.66 (116.3)
Ratio from week 0 to week 80	0.58 (112.9)	0.53 (106.2)	0.42 (132.5)	0.54 (154.4)

81. Secondary Outcome

Title	Change in Fasting Glucagon- Ratio to Baseline
Description	Change in fasting glucagon (measured in picogram per milliliter [pg/mL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Ratio from week 0 to week 54	1.01 (32.1)	0.95 (32.5)	0.96 (31.3)	1.00 (31.4)
Ratio from week 0 to week 80	0.89 (36.2)	0.85 (30.7)	0.96 (32.8)	0.93 (37.8)

82. Secondary Outcome

Title	7-point SMPG Profiles
Description	Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.
Time Frame	Week 54 and Week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 54: Before breakfast	6.8 (3.4)	6.8 (2.7)	6.4 (2.2)	6.3 (1.4)
Week 54: 90 minutes after start of breakfast	8.9 (3.7)	7.5 (2.4)	7.4 (2.1)	7.6 (2.4)
Week 54: Before lunch	5.5 (1.8)	6.4 (2.3)	6.1 (1.8)	6.0 (1.6)
Week 54: 90 minutes after start of lunch	8.2 (2.6)	7.5 (2.7)	7.8 (2.4)	7.7 (2.0)
Week 54: Before dinner	6.5 (1.9)	6.5 (2.5)	6.6 (2.2)	6.1 (1.7)
Week 54: 90 minutes after start of dinner	8.2 (3.4)	7.0 (2.5)	7.2 (2.3)	6.8 (1.9)
Week 54: Bedtime	7.8 (3.9)	7.4 (2.6)	7.5 (2.5)	7.2 (2.1)
Week 80: Before breakfast	6.5 (1.7)	6.4 (2.0)	7.2 (2.7)	6.8 (2.0)
Week 80: 90 minutes after start of breakfast	8.5 (2.8)	7.2 (3.0)	8.3 (3.7)	7.5 (2.7)
Week 80: Before lunch	6.2 (2.2)	6.2 (2.0)	6.9 (3.3)	6.1 (1.8)
Week 80: 90 minutes after start of lunch	7.8 (2.6)	7.6 (2.7)	8.5 (4.5)	8.0 (3.0)
Week 80: Before dinner	6.5 (2.2)	6.7 (2.9)	7.6 (4.1)	6.5 (1.6)
Week 80: 90 minutes after start of dinner	7.6 (2.5)	7.0 (2.1)	9.0 (5.0)	7.6 (2.5)
Week 80: Bedtime	7.8 (3.0)	6.6 (1.8)	7.8 (4.4)	7.4 (2.2)

83. Secondary Outcome

Title	Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner
Description	Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54: Breakfast	1.3 (4.0)	0.4 (3.0)	-0.1 (3.8)	-0.6 (2.4)
Change from week 0 to week 80: Breakfast	1.9 (4.2)	0.5 (4.0)	-0.1 (4.5)	-0.5 (4.5)
Change from week 0 to week 54: Lunch	0.9 (4.5)	0.5 (3.4)	1.5 (2.9)	0.7 (2.7)
Change from week 0 to week 80: Lunch	0.0 (4.5)	0.1 (3.0)	1.0 (3.5)	0.8 (4.5)
Change from week 0 to week 54: Dinner	0.1 (4.5)	1.1 (4.0)	-0.8 (4.7)	-0.3 (3.1)
Change from week 0 to week 80: Dinner	0.5 (5.0)	0.5 (3.4)	-0.4 (4.3)	-0.4 (3.2)

84. Secondary Outcome

Title	Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)
Description	Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.9 (2.3)	0.6 (2.2)	0.2 (2.0)	-0.1 (2.0)
Change from week 0 to week 80	0.8 (2.6)	0.4 (2.2)	0.0 (2.5)	-0.0 (2.9)

85. Secondary Outcome

Title	Change in Mean of 7-point Profiles
Description	Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Change from week 0 to week 54	0.5 (2.0)	0.3 (2.4)	-0.1 (1.9)	0.0 (1.2)
Change from week 0 to week 80	0.1 (2.1)	0.0 (2.3)	0.7 (1.6)	0.3 (1.7)

86. Secondary Outcome

Title	Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)
Description	Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.
Time Frame	Week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 54	6.8 (3.4)	6.8 (2.7)	6.4 (2.2)	6.3 (1.4)
Week 80	6.5 (1.7)	6.4 (2.0)	7.2 (2.7)	6.8 (2.0)

87. Secondary Outcome

Title	Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)
Description	AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time Frame	Pre-dose and 1 hour post-dose during week 48 to week 54

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	17	16
Geometric Mean (Geometric Coefficient of Variation) [day*microgram per milliliter (day*ug/mL)]	3969 (17.9)	4115 (23.1)

88. Secondary Outcome

Title	Terminal Half-life (t½) After Last Dose of NNC0114-0006
Description	Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time Frame	Pre-dose and 1 hour post-dose during week 48 to week 80

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	17	16
Geometric Mean (Geometric Coefficient of Variation) [Days]	22.3 (17.9)	22.2 (16.5)

89. Secondary Outcome

Title	Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)
Description	The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time Frame	Pre-dose and 1 hour post-dose during week 48 to week 80

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	17	16
Geometric Mean (Geometric Coefficient of Variation) [Milliliters per kilogram (mL/kg)]	83.7 (23.1)	79.3 (17.6)

90. Secondary Outcome

Title	Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)
Description	Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time Frame	Pre-dose and 1 hour post-dose during week 48 to week 54

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	17	16
Geometric Mean (Geometric Coefficient of Variation) [(Milliliters/day)/kilogram ([mL/day]/kg)]	3.02 (17.9)	2.92 (23.1)

91. Secondary Outcome

Title	Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)
Description	This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.
Time Frame	Pre-dose and 1 hour post-dose during week 48 to week 80

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	17	16
Geometric Mean (Geometric Coefficient of Variation) [Days]	27.7 (24.5)	27.2 (22.6)

92. Secondary Outcome

Title	Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)
Description	Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time Frame	Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	16	16
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	1.24 (17.8)	1.26 (17.4)

93. Secondary Outcome

Title	Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)
Description	Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time Frame	Week 48 (predose)

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	17	16
Geometric Mean (Geometric Coefficient of Variation) [microgram/milliliter (ug/mL)]	34.7 (42.3)	36.7 (36.8)

94. Secondary Outcome

Title	Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)
Description	C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time Frame	Week 48 (1 hour post-dose)

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	14	15
Geometric Mean (Geometric Coefficient of Variation) [ug/mL]	298.6 (16.8)	282.6 (56.4)

95. Secondary Outcome

Title	Liraglutide Concentration at Steady State (C Liraglutide)
Description	C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.
Time Frame	Week 54 (post-dose)

Outcome Measure Data

Analysis Population Description

The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	Liraglutide (Experimental)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	17	19
Geometric Mean (Geometric Coefficient of Variation) [picomole per liter (pmol/L)]	16287 (41.7)	15920 (66.0)

96. Secondary Outcome

Title	Change in Biomarker: Immune Phenotyping- B Cell Panel
Description	B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0: Activated Memory B-Cells	1.3 (0.9)	1.4 (1.0)	1.6 (1.1)	1.5 (1.0)
Week 54: Activated Memory B-Cells	1.2 (0.8)	1.1 (1.0)	1.5 (1.3)	1.3 (0.8)
Week 80: Activated Memory B-Cells	1.2 (0.9)	1.1 (0.7)	1.5 (1.1)	1.5 (1.2)
Week 0: Mature Naive B-Cells	15.1 (6.7)	14.0 (7.1)	13.6 (6.9)	13.3 (7.4)
Week 54: Mature Naive B-Cells	14.0 (6.2)	14.3 (7.9)	13.6 (7.6)	13.5 (6.9)
Week 80: Mature Naive B-Cells	14.3 (7.3)	14.2 (8.7)	12.0 (5.2)	12.8 (7.6)
Week 0: Antibody-Secreting Cells	0.6 (0.4)	0.5 (0.5)	0.6 (0.3)	0.6 (0.6)
Week 54: Antibody-Secreting Cells	0.6 (0.5)	0.4 (0.4)	0.5 (0.3)	0.6 (0.7)
Week 80: Antibody-Secreting Cells	0.5 (0.4)	0.4 (0.3)	0.4 (0.4)	0.6 (0.5)
Week 0: B-Cells Positive For Both CD19 & CD20	71.9 (9.7)	71.1 (11.1)	72.1 (8.9)	72.2 (8.8)
Week 54: B-Cells Positive For Both CD19 & CD20	71.1 (12.4)	70.8 (12.4)	72.1 (8.4)	65.9 (13.6)
Week 80: B-Cells Positive For Both CD19 & CD20	71.0 (10.7)	69.8 (11.2)	72.8 (10.6)	69.6 (13.5)
Week 0: CD20Neg B-Cell	0.6 (0.5)	0.6 (0.7)	0.6 (0.7)	0.6 (0.5)
Week 54: CD20Neg B-Cell	0.6 (0.7)	0.5 (0.9)	0.5 (0.4)	0.6 (0.7)
Week 80: CD20Neg B-Cell	0.5 (0.3)	0.5 (0.4)	0.6 (1.8)	0.7 (1.0)
Week 0: CD24- B-Cells	29.8 (10.2)	31.0 (11.5)	31.5 (11.8)	32.0 (11.1)
Week 54: CD24- B-Cells	30.2 (9.4)	30.6 (10.8)	31.3 (11.9)	28.3 (8.9)
Week 80: CD24- B-Cells	30.0 (8.9)	31.6 (10.9)	33.4 (12.4)	30.7 (11.8)
Week 0: Class-Switched Memory B Cells	5.0 (3.3)	4.6 (2.5)	4.8 (3.3)	4.9 (3.0)
Week 54: Class-Switched Memory B Cells	5.0 (3.7)	4.2 (2.3)	4.6 (2.9)	4.8 (2.9)
Week 80: Class-Switched Memory B Cells	4.6 (3.3)	3.6 (2.0)	4.6 (3.0)	4.5 (2.5)
Week 0: IgMNeg IgDNeg Switched Memory B-cells	0.1 (0.1)	0.1 (0.1)	0.1 (0.1)	0.1 (0.1)
Week 54: IgMNeg IgDNeg Switched Memory B-cells	0.1 (0.1)	0.1 (0.1)	0.1 (0.2)	0.1 (0.1)
Week 80: IgMNeg IgDNeg Switched Memory B-cells	0.1 (0.1)	0.2 (0.2)	0.1 (0.1)	0.1 (0.1)
Week 0: Non-Class Switched Memory B-Cells	10.2 (6.4)	9.6 (5.8)	9.6 (5.8)	10.1 (6.4)
Week 54: Non-Class Switched Memory B-Cells	8.5 (4.8)	9.0 (5.7)	8.7 (5.8)	8.9 (5.8)
Week 80: Non-Class Switched Memory B-Cells	8.2 (4.9)	7.2 (4.1)	8.0 (5.1)	8.9 (6.2)
Week 0: Total B-Cell Population	72.5 (9.8)	71.7 (11.2)	72.7 (9.0)	72.8 (8.6)
Week 54: Total B-Cell Population	71.7 (12.1)	71.3 (11.9)	72.6 (8.4)	66.5 (13.3)
Week 80: Total B-Cell Population	71.4 (10.7)	70.3 (11.2)	73.5 (9.6)	70.4 (13.0)
Week 0: Transitional B-Cells	11.4 (6.1)	9.9 (6.5)	9.5 (5.5)	9.6 (6.6)
Week 54: Transitional B-Cells	10.2 (5.6)	10.7 (7.7)	9.5 (6.3)	9.8 (6.4)
Week 80: Transitional B-Cells	10.8 (6.8)	10.5 (8.1)	8.1 (4.0)	8.9 (6.1)

97. Secondary Outcome

Title	Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel
Description	NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0: ADCC-Competent NK	39.5 (17.1)	36.3 (14.9)	36.0 (16.6)	34.7 (14.6)
Week 54: ADCC-Competent NK	37.1 (16.1)	32.5 (14.1)	33.9 (14.0)	31.5 (14.0)
Week 80: ADCC-Competent NK	37.1 (16.0)	33.2 (13.7)	31.9 (15.1)	34.1 (16.3)
Week 0: CD16+ Highly Functional NK Cells	0.8 (0.8)	0.8 (0.7)	0.7 (0.6)	0.7 (0.6)
Week 54: CD16+ Highly Functional NK Cells	0.7 (0.7)	0.7 (0.8)	0.7 (0.7)	0.6 (0.5)
Week 80: CD16+ Highly Functional NK Cells	0.7 (0.8)	0.6 (0.5)	0.6 (0.6)	0.8 (0.7)
Week 0: CD56- Cells	34.5 (15.9)	36.8 (15.5)	38.0 (17.1)	38.0 (13.6)
Week 54: CD56- Cells	34.8 (12.8)	36.6 (12.9)	38.1 (14.3)	41.1 (15.7)
Week 80: CD56- Cells	36.2 (14.3)	37.6 (13.7)	37.1 (11.7)	37.6 (12.7)
Week 0: CD56High NK Pool	4.9 (3.3)	5.1 (3.5)	4.5 (2.9)	4.9 (3.7)
Week 54: CD56High NK Pool	4.9 (3.1)	5.3 (3.4)	4.2 (2.9)	4.4 (3.0)
Week 80: CD56High NK Pool	4.5 (2.9)	5.1 (3.1)	4.3 (2.8)	5.4 (4.0)
Week 0: CD57+ MatNK Effectors	22.6 (12.5)	20.4 (10.3)	21.0 (11.8)	19.0 (10.1)
Week 54: CD57+ MatNK Effectors	21.0 (12.5)	18.0 (10.1)	18.9 (10.6)	16.6 (9.4)
Week 80: CD57+ MatNK Effectors	20.0 (11.2)	18.3 (9.0)	17.5 (11.1)	17.3 (9.6)
Week 0: Functional NK Cells; Efficient At ADCC	14.5 (7.8)	13.3 (8.5)	13.1 (9.7)	12.1 (6.4)
Week 54: Functional NK Cells; Efficient At ADCC	13.2 (8.5)	11.1 (7.2)	12.1 (7.1)	11.0 (7.2)
Week 80: Functional NK Cells; Efficient At ADCC	13.3 (7.4)	11.3 (7.1)	10.9 (7.2)	12.6 (9.4)
Week 0: Highly Cytolytic Subset Of NK Cells	18.8 (10.4)	20.9 (10.3)	20.6 (11.0)	21.4 (9.4)
Week 54: Highly Cytolytic Subset Of NK Cells	22.2 (10.7)	24.5 (11.0)	22.8 (11.5)	22.1 (11.0)
Week 80: Highly Cytolytic Subset Of NK Cells	21.1 (9.7)	23.0 (9.1)	25.5 (11.4)	21.9 (9.9)
Week 0: Mature CD16+ Highly Functional NK Cells	0.7 (0.7)	0.7 (0.6)	0.6 (0.6)	0.7 (0.6)
Week 54: Mature CD16+ Highly Functional NK Cells	0.6 (0.6)	0.6 (0.8)	0.6 (0.7)	0.6 (0.5)
Week 80: Mature CD16+ Highly Functional NK Cells	0.6 (0.7)	0.6 (0.5)	0.5 (0.6)	0.7 (0.7)
Week 0: Mature CD16+ Terminally Differentiated	1.3 (1.3)	1.1 (1.2)	1.1 (1.1)	1.3 (1.1)
Week 54: Mature CD16+ Terminally Differentiated	0.9 (0.7)	0.8 (0.7)	1.0 (0.9)	1.1 (0.9)
Week 80: Mature CD16+ Terminally Differentiated	1.1 (1.1)	1.0 (1.0)	0.8 (0.9)	1.3 (1.0)
Week 0: Mature CD16- Terminally Differentiate NK	0.3 (0.2)	0.3 (0.2)	0.4 (0.4)	0.4 (0.3)
Week 54: Mature CD16- Terminally Differentiate NK	0.3 (0.2)	0.3 (0.2)	0.3 (0.3)	0.4 (0.2)
Week 80: Mature CD16- Terminally Differentiate NK	0.3 (0.2)	0.3 (0.3)	0.4 (0.3)	1.0 (4.2)
Week 0: Mature Cytolytic NK Cells	2.3 (1.4)	2.2 (1.1)	2.4 (1.7)	2.3 (1.3)
Week 54: Mature Cytolytic NK Cells	2.4 (1.4)	2.7 (1.5)	2.5 (1.6)	2.4 (1.7)
Week 80: Mature Cytolytic NK Cells	2.3 (1.2)	2.9 (3.7)	2.6 (2.3)	2.5 (1.5)
Week 0: Mature Rapid Cytokine-Producing NK Cell	3.6 (2.5)	3.8 (2.8)	3.3 (2.2)	3.6 (2.8)
Week 54: Mature Rapid Cytokine-Producing NK Cell	3.6 (2.4)	3.9 (2.4)	3.0 (2.0)	3.3 (2.4)
Week 80: Mature Rapid Cytokine-Producing NK Cell	3.2 (2.0)	3.7 (2.4)	3.0 (1.9)	3.9 (3.0)
Week 0: Rapid Cytokine-Producing NK Cell Subset	4.1 (2.7)	4.4 (3.1)	3.8 (2.6)	4.1 (3.2)
Week 54: Rapid Cytokine-Producing NK Cell Subset	4.2 (2.7)	4.5 (2.8)	3.5 (2.3)	3.8 (2.6)
Week 80: Rapid Cytokine-Producing NK Cell Subset	3.8 (2.3)	4.4 (2.7)	3.7 (2.3)	4.6 (3.4)
Week 0: Senescent CD16+ CD56- NK cells	1.3 (1.8)	1.2 (1.9)	1.0 (1.1)	1.2 (1.2)
Week 54: Senescent CD16+ CD56- NK cells	1.0 (1.1)	1.2 (1.5)	0.9 (0.9)	1.1 (1.1)
Week 80: Senescent CD16+ CD56- NK cells	1.1 (1.4)	1.4 (1.5)	0.9 (0.9)	1.2 (1.0)
Week 0: Senescent CD16+CD56hi NK	0.1 (0.2)	0.1 (0.1)	0.1 (0.1)	0.1 (0.1)
Week 54: Week 0: Senescent CD16+CD56hi NK	0.1 (0.1)	0.0 (0.1)	0.1 (0.1)	0.0 (0.1)
Week 80: Week 0: Senescent CD16+CD56hi NK	0.1 (0.1)	0.0 (0.0)	0.1 (0.1)	0.1 (0.1)
Week 0: Senescent CD16- CD56- NK cells	1.3 (1.0)	1.5 (1.6)	1.3 (1.0)	1.5 (1.1)
Week 54: Senescent CD16- CD56- NK cells	1.5 (1.2)	1.8 (1.3)	1.6 (1.3)	2.0 (2.9)
Week 80: Senescent CD16- CD56- NK cells	1.9 (2.0)	2.4 (3.7)	1.9 (1.3)	2.2 (3.3)
Week 0: Senescent Cytolytic NK Cells	8.7 (6.6)	9.9 (7.2)	9.8 (7.2)	9.9 (6.0)
Week 54: Senescent Cytolytic NK Cells	9.9 (6.3)	11.3 (7.6)	10.9 (7.9)	9.6 (6.7)
Week 80: Senescent Cytolytic NK Cells	9.4 (6.1)	11.1 (7.1)	11.5 (7.9)	9.8 (7.3)
Week 0: Senescent Rapid Cytokine-Producing NK	0.1 (0.3)	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)
Week 54: Senescent Rapid Cytokine-Producing NK	0.0 (0.0)	0.0 (0.0)	0.0 (0.1)	0.0 (0.0)
Week 80: Senescent Rapid Cytokine-Producing NK	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.0 (0.1)
Week 0: Total CD16+ CD56- NK	6.7 (3.8)	7.4 (5.1)	6.4 (3.5)	7.3 (3.8)
Week 54: Total CD16+ CD56- NK	5.9 (2.6)	6.2 (3.8)	6.0 (3.1)	6.8 (3.5)
Week 80: Total CD16+ CD56- NK	6.8 (5.8)	6.6 (4.1)	6.2 (3.0)	7.3 (3.5)
Week 0: Total CD16- CD56- NK	27.6 (15.4)	29.2 (13.2)	31.4 (16.7)	30.5 (13.0)
Week 54: Week 0: Total CD16- CD56- NK	28.6 (12.2)	30.1 (11.9)	31.9 (13.3)	34.0 (14.1)
Week 80: Week 0: Total CD16- CD56- NK	29.2 (12.7)	30.7 (13.2)	30.7 (10.2)	30.0 (12.2)
Week 0: Total Mature NK Cells; Highly Cytolytic	58.6 (13.4)	57.4 (15.1)	56.8 (16.6)	56.3 (13.7)
Week 54: Total Mature NK Cells; Highly Cytolytic	59.6 (13.4)	57.3 (12.9)	56.9 (13.8)	53.7 (15.0)
Week 80: Total Mature NK Cells; Highly Cytolytic	58.5 (13.9)	56.5 (13.4)	57.7 (12.1)	56.2 (11.6)

98. Secondary Outcome

Title	Change in Biomarker: Immune Phenotyping- T Cell Panel
Description	T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0: Activated CD4 TEMRA	10.1 (7.1)	9.7 (5.4)	10.8 (6.8)	9.7 (6.5)
Week 54: Activated CD4 TEMRA	10.3 (5.9)	8.7 (5.3)	9.7 (5.4)	9.3 (6.0)
Week 80: Activated CD4 TEMRA	9.1 (5.5)	8.1 (5.5)	8.1 (4.9)	8.7 (5.0)
Week 0: Activated CD8 TEMRA	0.9 (1.2)	0.8 (1.4)	0.6 (0.6)	1.0 (1.9)
Week 54: Activated CD8 TEMRA	0.9 (1.5)	0.6 (0.7)	0.6 (0.6)	0.7 (1.0)
Week 80: Activated CD8 TEMRA	0.7 (0.9)	0.6 (0.7)	0.6 (0.6)	1.1 (2.3)
Week 0: Activated Central Memory CD4	6.3 (3.3)	6.7 (3.1)	7.1 (3.8)	6.1 (3.2)
Week 54: Activated Central Memory CD4	6.3 (3.1)	6.1 (3.1)	6.3 (2.9)	6.2 (3.1)
Week 80: Activated Central Memory CD4	6.5 (3.0)	6.0 (2.6)	6.0 (2.6)	6.5 (2.8)
Week 0: Activated Central Memory CD8	1.1 (1.2)	1.7 (1.8)	1.6 (1.7)	1.1 (1.0)
Week 54: Activated Central Memory CD8	1.4 (1.6)	1.6 (1.8)	1.5 (1.4)	3.1 (13.3)
Week 80: Activated Central Memory CD8	2.2 (6.5)	1.4 (1.5)	1.6 (2.3)	1.9 (4.5)
Week 0: Activated Effector Memory CD4	10.3 (5.8)	10.9 (5.6)	11.3 (6.4)	9.4 (4.8)
Week 54: Activated Effector Memory CD4	10.1 (5.4)	9.6 (5.2)	10.0 (4.9)	9.2 (4.8)
Week 80: Activated Effector Memory CD4	10.2 (6.6)	8.9 (4.3)	9.5 (4.8)	9.1 (4.3)
Week 0: Activated Effector Memory CD8	1.9 (3.6)	1.7 (2.9)	1.2 (1.4)	0.9 (1.2)
Week 54: Activated Effector Memory CD8	2.0 (3.7)	1.6 (2.4)	1.2 (1.2)	1.1 (1.4)
Week 80: Activated Effector Memory CD8	1.9 (3.4)	1.5 (2.8)	1.4 (2.0)	1.1 (1.4)
Week 0: Activated Mature Naive CD4 T-Cells	4.0 (2.0)	4.0 (1.9)	4.7 (2.4)	3.9 (1.8)
Week 54: Activated Mature Naive CD4 T-Cells	3.9 (2.1)	3.8 (1.8)	4.5 (2.3)	3.7 (1.4)
Week 80: Activated Mature Naive CD4 T-Cells	4.0 (2.4)	3.8 (1.4)	4.0 (1.9)	3.9 (1.7)
Week 0: Activated Mature Naive CD8 T-Cells	3.4 (3.7)	2.8 (2.3)	3.3 (3.5)	3.5 (3.7)
Week 54: Activated Mature Naive CD8 T-Cells	3.0 (3.3)	2.6 (3.0)	2.6 (2.7)	3.1 (3.6)
Week 80: Activated Mature Naive CD8 T-Cells	2.7 (2.1)	2.6 (2.5)	2.5 (2.7)	3.1 (3.2)
Week 0: CCR5+ CD4 TEMRA	17.7 (12.2)	16.4 (8.1)	16.9 (11.1)	18.9 (12.8)
Week 54: CCR5+ CD4 TEMRA	18.4 (12.2)	17.7 (10.3)	18.8 (13.5)	21.0 (17.3)
Week 80: CCR5+ CD4 TEMRA	18.3 (11.0)	19.5 (13.6)	18.6 (11.9)	21.4 (15.1)
Week 0: CCR5+ CD4 Treg TEMRA	3.7 (10.6)	1.7 (1.8)	2.7 (4.7)	3.9 (8.6)
Week 54: CCR5+ CD4 Treg TEMRA	4.2 (9.1)	4.2 (10.4)	4.6 (10.5)	4.6 (9.3)
Week 80: CCR5+ CD4 Treg TEMRA	2.8 (4.6)	4.4 (10.4)	3.2 (5.7)	4.4 (9.3)
Week 0: CCR5+ CD8 EM	35.3 (14.5)	35.5 (13.8)	38.2 (14.1)	37.7 (15.8)
Week 54: CCR5+ CD8 EM	37.9 (14.1)	36.4 (13.5)	38.0 (14.4)	38.8 (15.5)
Week 80: CCR5+ CD8 EM	38.8 (15.3)	34.7 (12.4)	37.5 (14.1)	40.0 (16.3)
Week 0: CCR5+ CD8 TEMRA	22.8 (10.2)	22.9 (10.9)	25.9 (12.9)	24.3 (12.6)
Week 54: CCR5+ CD8 TEMRA	25.9 (10.7)	25.0 (9.7)	26.3 (12.1)	25.4 (11.6)
Week 80: CCR5+ CD8 TEMRA	25.9 (11.3)	24.4 (11.3)	26.8 (13.4)	26.9 (13.1)
Week 0: CCR5+ Central Memory CD4 Cells	4.1 (2.4)	4.3 (2.3)	4.5 (2.9)	4.5 (3.2)
Week 54: CCR5+ Central Memory CD4 Cells	4.5 (2.5)	4.1 (2.0)	4.1 (2.8)	4.9 (3.4)
Week 80: CCR5+ Central Memory CD4 Cells	4.9 (2.5)	4.9 (3.7)	5.1 (3.4)	5.7 (4.7)
Week 0: CCR5+ Central Memory CD8 Cells	15.0 (10.6)	14.4 (9.0)	16.9 (10.3)	16.7 (11.1)
Week 54: CCR5+ Central Memory CD8 Cells	16.8 (9.0)	14.2 (9.7)	15.8 (9.7)	18.5 (15.6)
Week 80: CCR5+ Central Memory CD8 Cells	16.8 (8.9)	15.5 (8.9)	15.8 (9.2)	19.3 (13.5)
Week 0: CCR5+ Central Memory Regulatory T-Cells	1.9 (1.7)	1.8 (1.4)	1.8 (1.9)	1.5 (1.1)
Week 54: CCR5+ Central Memory Regulatory T-Cells	2.0 (1.7)	1.5 (1.3)	1.7 (1.8)	1.7 (1.3)
Week 80: CCR5+ Central Memory Regulatory T-Cells	2.1 (1.9)	1.8 (1.7)	1.9 (1.9)	2.2 (2.4)
Week 0: CCR5+ Effector Memory CD4	15.5 (7.9)	14.5 (7.6)	15.5 (8.3)	15.3 (7.4)
Week 54: CCR5+ Effector Memory CD4	16.2 (7.7)	15.7 (7.6)	14.9 (7.5)	16.9 (9.6)
Week 80: CCR5+ Effector Memory CD4	17.5 (7.5)	16.8 (9.2)	16.4 (8.0)	18.4 (10.9)
Week 0: CCR5+ Effector Memory Regulatory T-Cells	4.7 (3.5)	5.1 (3.3)	4.5 (3.9)	4.1 (2.3)
Week 54: CCR5+ Effector Memory Regulatory T-Cells	4.8 (3.0)	4.6 (3.1)	4.4 (3.3)	4.5 (2.5)
Week 80: CCR5+ Effector Memory Regulatory T-Cells	5.2 (3.6)	5.2 (4.0)	5.4 (5.3)	5.2 (3.2)
Week 0: CCR5+ Naive CD4 T-Cells	1.9 (1.5)	2.0 (1.3)	2.1 (1.9)	2.0 (1.8)
Week 54: CCR5+ Naive CD4 T-Cells	2.0 (1.5)	2.1 (2.1)	2.1 (1.9)	2.3 (2.2)
Week 80: CCR5+ Naive CD4 T-Cells	2.3 (1.6)	2.9 (3.9)	2.8 (3.0)	3.5 (5.1)
Week 0: CCR5+ Naive CD8 T-Cells	3.7 (2.3)	3.5 (1.9)	4.1 (2.8)	4.2 (3.2)
Week 54: CCR5+ Naive CD8 T-Cells	3.4 (1.7)	3.5 (2.4)	3.5 (2.1)	4.1 (2.9)
Week 80: CCR5+ Naive CD8 T-Cells	3.8 (1.8)	4.0 (4.3)	4.3 (3.1)	4.9 (4.7)
Week 0: CCR5+ Naive Regulatory T-Cells	6.1 (6.5)	5.0 (3.6)	6.5 (8.3)	6.5 (8.8)
Week 54: CCR5+ Naive Regulatory T-Cells	6.7 (10.1)	6.3 (7.3)	4.8 (5.5)	5.3 (5.2)
Week 80: CCR5+ Naive Regulatory T-Cells	5.8 (4.9)	6.5 (8.4)	5.7 (6.5)	7.1 (8.0)
Week 0: CD4 TEMRA	3.7 (4.9)	2.6 (1.7)	3.1 (2.5)	2.7 (2.3)
Week 54: CD4 TEMRA	3.8 (5.7)	2.9 (2.3)	3.3 (2.8)	3.1 (3.2)
Week 80: CD4 TEMRA	4.4 (5.8)	3.2 (2.3)	3.6 (3.2)	3.5 (2.6)
Week 0: CD8 Central Memory	2.0 (1.8)	2.0 (2.1)	1.8 (1.5)	1.9 (1.3)
Week 54: CD8 Central Memory	1.8 (1.2)	2.1 (2.3)	1.7 (1.4)	2.1 (1.6)
Week 80: CD8 Central Memory	1.8 (1.6)	1.9 (2.0)	1.8 (1.5)	2.2 (2.0)
Week 0: CD8 Effector Memory	14.3 (7.9)	14.7 (7.6)	13.4 (7.7)	15.7 (6.9)
Week 54: CD8 Effector Memory	15.1 (7.6)	14.8 (7.8)	11.3 (6.6)	16.4 (7.4)
Week 80: CD8 Effector Memory	15.1 (8.0)	16.5 (9.0)	13.9 (7.6)	17.4 (7.5)
Week 0: CD8 TEMRA	31.6 (12.8)	30.9 (13.9)	29.0 (12.8)	32.3 (13.8)
Week 54: CD8 TEMRA	29.8 (12.3)	31.0 (13.9)	30.3 (12.9)	30.4 (13.3)
Week 80: CD8 TEMRA	31.9 (14.3)	33.5 (13.1)	30.4 (13.0)	33.4 (14.6)
Week 0: Conventional Central Memory CD4 T-Cells	20.0 (9.9)	22.1 (8.0)	20.3 (8.1)	21.6 (8.0)
Week 54: Conventional Central Memory CD4 T-Cells	20.4 (8.1)	22.2 (9.3)	19.9 (7.8)	21.1 (8.0)
Week 80: Conventional Central Memory CD4 T-Cells	19.4 (8.4)	21.7 (7.8)	19.9 (8.2)	21.1 (8.7)
Week 0: Conventional Effector Memory CD4 T-Cells	19.2 (10.7)	22.8 (10.3)	19.5 (9.5)	20.7 (9.2)
Week 54: Conventional Effector Memory CD4 T-Cells	20.3 (9.6)	22.9 (11.0)	20.5 (10.7)	21.3 (9.7)
Week 80: Conventional Effector Memory CD4 T-Cells	20.0 (9.8)	24.4 (11.3)	20.9 (11.7)	23.2 (10.0)
Week 0: Naive CD4 T-Cells	57.0 (14.7)	52.4 (14.4)	57.0 (12.6)	54.9 (13.2)
Week 54: Naive CD4 T-Cells	55.4 (11.9)	51.8 (15.0)	56.3 (13.9)	54.5 (12.5)
Week 80: Naive CD4 T-Cells	56.1 (11.9)	50.6 (16.2)	55.6 (15.1)	52.1 (14.5)
Week 0: Naive CD8 T-Cells	52.0 (15.9)	52.5 (19.1)	55.8 (17.0)	50.1 (17.4)
Week 54: Naive CD8 T-Cells	53.2 (14.9)	52.1 (18.1)	54.7 (15.4)	51.1 (17.4)
Week 80: Naive CD8 T-Cells	51.1 (16.0)	48.1 (19.2)	53.9 (17.4)	46.9 (17.6)
Week 0: Senescent CD4 Central Memory Cells	2.3 (1.9)	2.2 (1.5)	2.4 (2.6)	2.3 (2.7)
Week 54: Senescent CD4 Central Memory Cells	1.9 (1.5)	2.1 (1.7)	2.2 (1.9)	2.4 (2.5)
Week 80: Senescent CD4 Central Memory Cells	2.3 (1.8)	2.3 (1.6)	2.1 (1.6)	2.6 (2.4)
Week 0: Senescent CD4 Effector Memory Cells	6.9 (5.5)	6.3 (5.6)	6.9 (5.4)	6.7 (6.5)
Week 54: Senescent CD4 Effector Memory Cells	5.9 (5.8)	6.7 (6.0)	6.6 (4.9)	7.5 (9.0)
Week 80: Senescent CD4 Effector Memory Cells	6.9 (5.9)	7.0 (5.2)	6.4 (4.7)	7.6 (7.4)
Week 0: Senescent CD8 Central Memory Cells	12.1 (10.1)	11.5 (9.1)	12.9 (9.7)	12.4 (12.7)
Week 54: Senescent CD8 Central Memory Cells	11.7 (9.5)	10.4 (9.2)	12.0 (10.2)	12.2 (14.5)
Week 80: Senescent CD8 Central Memory Cells	12.7 (9.0)	12.7 (9.9)	11.3 (9.8)	12.2 (11.9)
Week 0: Senescent CD8 Effector Memory Cells	27.3 (14.8)	27.2 (15.5)	27.7 (13.6)	29.1 (17.4)
Week 54: Senescent CD8 Effector Memory Cells	25.2 (13.1)	25.1 (14.3)	26.1 (12.8)	25.8 (14.7)
Week 80: Senescent CD8 Effector Memory Cells	27.5 (14.5)	28.6 (15.7)	26.5 (14.1)	26.6 (15.5)
Week 0: Senescent Naive CD4 T-Cells	2.6 (2.7)	2.9 (3.3)	2.6 (2.3)	2.5 (2.3)
Week 54: Senescent Naive CD4 T-Cells	2.5 (2.5)	3.0 (3.8)	2.8 (3.0)	2.7 (2.4)
Week 80: Senescent Naive CD4 T-Cells	3.1 (3.3)	3.3 (3.8)	3.1 (3.7)	3.9 (5.3)
Week 0: Senescent Naive CD8 T-Cells	3.9 (3.4)	3.6 (3.5)	3.5 (3.1)	4.2 (4.4)
Week 54: Senescent Naive CD8 T-Cells	3.5 (2.9)	3.8 (4.5)	3.7 (4.3)	4.2 (3.6)
Week 80: Senescent Naive CD8 T-Cells	4.4 (4.3)	4.3 (4.7)	3.8 (3.6)	4.5 (4.1)
Week 0: Senescent Naive TREG	6.9 (7.9)	5.5 (3.7)	7.1 (8.5)	7.3 (9.3)
Week 54: Senescent Naive TREG	7.2 (10.9)	6.8 (7.8)	5.0 (5.5)	5.6 (5.2)
Week 80: Senescent Naive TREG	6.3 (5.7)	7.0 (8.9)	6.0 (7.2)	7.4 (8.2)
Week 0: Senescent TEMRA CD4	23.3 (19.8)	21.7 (18.4)	21.9 (21.7)	22.0 (20.1)
Week 54: Senescent TEMRA CD4	20.0 (17.1)	22.8 (18.3)	23.1 (22.2)	23.5 (21.7)
Week 80: Senescent TEMRA CD4	21.0 (19.5)	24.2 (18.1)	21.7 (21.5)	25.4 (21.6)
Week 0: Senescent TEMRA CD8	42.8 (20.2)	40.3 (21.0)	37.7 (19.4)	42.0 (23.0)
Week 54: Senescent TEMRA CD8	39.2 (19.8)	40.7 (21.3)	38.3 (18.4)	40.4 (22.9)
Week 80: Senescent TEMRA CD8	42.7 (21.4)	44.8 (20.9)	38.7 (20.4)	43.5 (23.1)
Week 0: Senescent TEMRA TREG	3.6 (19.7)	1.8 (1.9)	2.8 (4.6)	4.0 (8.6)
Week 54: Senescent TEMRA TREG	3.9 (9.0)	4.2 (10.4)	4.6 (10.5)	4.6 (9.1)
Week 80: Senescent TEMRA TREG	2.6 (4.5)	4.4 (10.4)	3.2 (5.7)	4.4 (9.3)
Week 0: Senescent TREG CM	0.1 (0.1)	0.1 (0.1)	0.1 (0.2)	0.2 (0.2)
Week 54: Senescent TREG CM	0.1 (0.1)	0.1 (0.1)	0.1 (0.2)	0.2 (0.2)
Week 80: Senescent TREG CM	0.2 (0.2)	0.2 (0.1)	0.1 (0.2)	0.3 (0.5)
Week 0: Senescent TREG EM	0.4 (0.4)	0.4 (0.3)	0.4 (0.5)	0.4 (0.4)
Week 54: Senescent TREG EM	0.4 (0.4)	0.3 (0.3)	0.3 (0.3)	0.5 (0.5)
Week 80: Senescent TREG EM	0.5 (0.7)	0.5 (0.9)	0.5 (0.7)	0.5 (0.7)
Week 0: Total Naive TREG	46.8 (18.1)	42.4 (14.1)	50.3 (14.2)	47.7 (17.6)
Week 54: Total Naive TREG	43.7 (15.6)	44.3 (15.8)	49.4 (15.4)	45.1 (13.7)
Week 80: Total Naive TREG	46.8 (15.7)	44.1 (18.3)	48.7 (17.0)	43.4 (15.2)
Week 0: Total TREG	3.9 (1.9)	3.8 (1.5)	4.1 (1.6)	3.5 (1.3)
Week 54: Total TREG	3.8 (1.5)	3.5 (1.5)	4.0 (1.5)	3.5 (1.2)
Week 80: Total TREG	3.7 (1.5)	3.5 (1.3)	3.4 (1.2)	3.4 (1.2)
Week 0: Total TREG CM	14.8 (9.2)	15.8 (8.1)	14.4 (7.9)	14.2 (7.9)
Week 54: Total TREG CM	15.5 (9.0)	15.6 (9.5)	13.8 (7.8)	15.0 (6.7)
Week 80: Total TREG CM	15.3 (8.7)	15.0 (8.2)	13.8 (7.4)	15.9 (8.2)
Week 0: Total TREG EM	30.8 (14.6)	36.4 (11.2)	28.8 (12.2)	30.7 (15.2)
Week 54: Total TREG EM	32.4 (14.6)	32.6 (12.5)	28.3 (12.9)	31.9 (13.6)
Week 80: Total TREG EM	30.7 (13.7)	33.5 (13.9)	30.2 (15.0)	32.9 (13.3)
Week 0: Total TREG TEMRA	7.6 (11.5)	5.5 (3.5)	6.7 (5.7)	7.5 (9.0)
Week 54: Total TREG TEMRA	8.5 (11.4)	7.7 (10.5)	8.6 (10.4)	8.2 (10.3)
Week 80: Total TREG TEMRA	7.3 (8.1)	7.4 (10.3)	7.5 (6.8)	7.8 (9.3)
Week 0: Total Viable CD4 T-Cells	54.7 (10.7)	53.2 (8.7)	54.6 (11.3)	54.6 (11.5)
Week 54: Total Viable CD4 T-Cells	54.3 (11.3)	52.1 (12.2)	54.6 (12.7)	52.7 (12.7)
Week 80: Total Viable CD4 T-Cells	51.9 (13.3)	50.3 (13.8)	53.1 (12.6)	52.2 (13.5)
Week 0: Total Viable CD8 T-Cells	26.1 (8.1)	28.2 (8.7)	25.8 (7.6)	26.6 (8.3)
Week 54: Total Viable CD8 T-Cells	25.0 (7.9)	26.7 (9.4)	24.6 (7.9)	24.0 (9.8)
Week 80: Total Viable CD8 T-Cells	24.2 (8.9)	25.4 (9.5)	23.5 (8.9)	23.9 (9.7)
Week 0: Total Viable T-Cells	55.6 (7.1)	55.2 (8.1)	55.3 (8.0)	55.0 (7.2)
Week 54: Total Viable T-Cells	53.6 (7.0)	55.9 (6.7)	57.4 (7.7)	55.5 (8.7)
Week 80: Total Viable T-Cells	52.7 (8.6)	55.3 (7.9)	56.2 (8.0)	55.8 (7.9)

99. Secondary Outcome

Title	Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel
Description	TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0: Activated cTfh17 Cells	0.8 (1.2)	1.0 (2.2)	0.8 (1.6)	0.6 (0.9)
Week 54: Activated cTfh17 Cells	0.6 (1.2)	0.4 (0.8)	0.7 (1.2)	0.9 (2.0)
Week 80: Activated cTfh17 Cells	0.8 (2.0)	1.1 (2.9)	0.6 (0.8)	0.9 (1.4)
Week 0: Activated cTfh2 Cells	0.6 (0.6)	0.6 (0.6)	0.6 (0.5)	0.6 (0.6)
Week 54: Activated cTfh2 Cells	0.4 (0.4)	0.4 (0.4)	0.7 (1.2)	0.6 (0.6)
Week 80: Activated cTfh2 Cells	0.6 (0.6)	0.5 (0.3)	0.5 (0.5)	0.6 (0.6)
Week 0:Activated PD1+ICOS+ cTfh1	1.3 (1.7)	1.9 (7.7)	1.1 (1.2)	1.0 (1.1)
Week 54: Activated PD1+ICOS+ cTfh1	0.7 (0.6)	1.0 (1.2)	1.2 (2.5)	1.2 (1.4)
Week 80: Activated PD1+ICOS+ cTfh1	0.7 (0.6)	0.9 (1.0)	1.0 (2.1)	1.1 (2.5)
Week 0: CCR7+ cTfh1 Cells	96.9 (2.5)	97.1 (3.5)	94.7 (13.4)	97.2 (2.2)
Week 54: CCR7+ cTfh1 Cells	97.1 (2.5)	95.8 (13.1)	97.1 (4.2)	97.3 (2.3)
Week 80: CCR7+ cTfh1 Cells	97.0 (3.0)	96.8 (3.0)	97.4 (2.1)	97.0 (2.3)
Week 0: CCR7+ cTfh17 Cells	97.4 (11.7)	97.4 (11.9)	97.4 (12.5)	97.3 (11.8)
Week 54: CCR7+ cTfh17 Cells	98.1 (2.9)	93.9 (22.3)	96.9 (12.9)	95.3 (18.3)
Week 80: CCR7+ cTfh17 Cells	98.7 (1.5)	97.3 (5.9)	96.8 (13.4)	98.7 (1.4)
Week 0: CCR7+ cTfh2 Cells	98.1 (1.6)	98.2 (1.4)	98.2 (1.5)	98.3 (1.4)
Week 54: CCR7+ cTfh2 Cells	98.1 (1.9)	98.5 (1.2)	98.3 (1.1)	98.1 (1.6)
Week 80: CCR7+ cTfh2 Cells	98.3 (1.5)	98.3 (1.8)	98.4 (1.1)	98.3 (1.0)
Week 0: CXCR4+ cTfh1 Cells	59.4 (27.6)	58.0 (25.9)	54.9 (27.8)	55.6 (29.2)
Week 54: CXCR4+ cTfh1 Cells	64.5 (28.7)	64.5 (28.8)	64.4 (29.3)	69.4 (25.0)
Week 80: CXCR4+ cTfh1 Cells	70.8 (24.5)	66.4 (27.4)	63.5 (30.3)	66.8 (25.2)
Week 0: CXCR4+ cTfh17 Cells	50.9 (30.4)	45.8 (27.8)	43.7 (29.3)	45.1 (31.4)
Week 54: CXCR4+ cTfh17 Cells	56.1 (31.1)	54.0 (29.3)	53.1 (31.4)	56.4 (29.6)
Week 80: CXCR4+ cTfh17 Cells	60.0 (27.4)	57.2 (30.3)	54.6 (31.4)	57.6 (28.5)
Week 0: CXCR4+ Ctfh2 Cells	58.8 (26.8)	56.3 (25.2)	54.0 (26.3)	54.5 (28.8)
Week 54: CXCR4+ Ctfh2 Cells	63.3 (28.2)	65.2 (27.3)	63.7 (28.5)	67.7 (25.3)
Week 80: CXCR4+ Ctfh2 Cells	69.3 (23.9)	65.8 (27.1)	62.7 (29.5)	66.7 (24.7)
Week 0: Circulating TFH-Cells (cTfh)	5.5 (3.7)	5.4 (3.4)	6.2 (3.3)	6.1 (3.7)
Week 54: Circulating TFH-Cells (cTfh)	5.7 (3.3)	5.6 (3.9)	6.2 (4.0)	6.2 (4.4)
Week 80: Circulating TFH-Cells (cTfh)	5.8 (3.3)	5.9 (4.1)	6.1 (4.2)	5.8 (3.8)
Week 0: ICOS+ CD4 CM	0.5 (0.5)	0.5 (0.5)	0.4 (0.3)	0.5 (0.4)
Week 54: ICOS+ CD4 CM	0.3 (0.2)	0.3 (0.2)	0.4 (0.2)	0.4 (0.3)
Week 80: ICOS+ CD4 CM	0.3 (0.3)	0.3 (0.2)	0.3 (0.2)	0.3 (0.2)
Week 0: ICOS+ CD4 EM	0.2 (0.2)	0.3 (0.6)	0.2 (0.2)	0.2 (0.2)
Week 54: ICOS+ CD4 EM	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)
Week 80: ICOS+ CD4 EM	0.2 (0.1)	0.2 (0.1)	0.2 (0.5)	0.2 (0.1)
Week 0: ICOS+ CD4 TEMRA	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)
Week 54: ICOS+ CD4 TEMRA	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)
Week 80: ICOS+ CD4 TEMRA	0.0 (0.0)	0.0 (0.0)	0.0 (0.1)	0.0 (0.0)
Week 0: ICOS+ NAIVE CD4 T-Cells	0.1 (0.1)	0.1 (0.1)	0.1 (0.1)	0.1 (0.1)
Week 54: ICOS+ NAIVE CD4 T-Cells	0.0 (0.1)	0.0 (0.0)	0.0 (0.1)	0.1 (0.1)
Week 80: ICOS+ NAIVE CD4 T-Cells	0.0 (0.1)	0.0 (0.0)	0.0 (0.1)	0.0 (0.0)
Week 0: ICOS+ NAIVE TREG	2.3 (1.8)	2.7 (3.4)	1.9 (2.1)	2.5 (2.8)
Week 54: ICOS+ NAIVE TREG	2.1 (2.0)	2.0 (2.4)	1.9 (2.5)	2.4 (2.5)
Week 80: ICOS+ NAIVE TREG	2.2 (2.2)	2.1 (2.4)	1.9 (2.3)	2.7 (2.7)
Week 0: ICOS+ TREG CM	10.9 (5.3)	11.3 (5.8)	10.4 (5.4)	11.0 (5.9)
Week 54: ICOS+ TREG CM	10.0 (5.2)	9.2 (4.4)	9.7 (4.7)	10.6 (5.1)
Week 80: ICOS+ TREG CM	10.1 (4.9)	9.0 (4.3)	8.8 (5.2)	10.5 (4.4)
Week 0: ICOS+ TREG EM	12.8 (6.4)	13.3 (6.8)	13.0 (6.2)	12.8 (6.5)
Week 54: ICOS+ TREG EM	11.9 (5.8)	11.6 (5.9)	12.8 (6.1)	12.7 (5.9)
Week 80: ICOS+ TREG EM	12.0 (5.5)	11.3 (5.4)	10.5 (5.3)	12.0 (5.8)
Week 0: ICOS+ TREG TEMRA	10.2 (10.6)	13.0 (18.4)	10.5 (11.4)	9.3 (8.6)
Week 54: ICOS+ TREG TEMRA	8.8 (10.5)	9.7 (10.7)	11.0 (12.6)	12.8 (15.1)
Week 80: ICOS+ TREG TEMRA	9.9 (9.8)	9.6 (10.1)	8.2 (9.2)	11.0 (10.5)
Week 0: PD1+ CD4 Central Memory	6.2 (4.0)	6.7 (4.9)	7.2 (5.3)	6.6 (4.3)
Week 54: PD1+ CD4 Central Memory	6.4 (4.7)	6.8 (5.4)	7.2 (5.4)	6.7 (3.9)
Week 80: PD1+ CD4 Central Memory	6.7 (5.5)	7.5 (5.9)	6.8 (4.8)	7.2 (5.3)
Week 0: PD1+ CD4 Effector Memory	4.0 (3.2)	4.2 (2.3)	4.0 (2.8)	4.1 (2.6)
Week 54: PD1+ CD4 Effector Memory	3.7 (3.0)	3.9 (2.2)	3.6 (2.3)	4.0 (2.5)
Week 80: PD1+ CD4 Effector Memory	3.9 (2.7)	4.3 (2.3)	3.6 (2.2)	4.3 (2.4)
Week 0: PD1+ Naive CD4	3.8 (6.1)	3.0 (4.7)	4.2 (6.8)	3.2 (4.4)
Week 54: PD1+ Naive CD4	4.2 (6.2)	2.9 (4.0)	4.4 (6.8)	3.5 (4.6)
Week 80: PD1+ Naive CD4	5.0 (8.4)	3.3 (4.6)	4.2 (6.6)	3.8 (6.2)
Week 0: PD1+ Naive TREG	8.4 (6.8)	8.7 (7.5)	8.4 (7.9)	8.5 (8.0)
Week 54: PD1+ Naive TREG	9.8 (7.9)	9.4 (9.5)	9.1 (8.5)	9.4 (8.2)
Week 80: PD1+ Naive TREG	11.0 (9.8)	10.1 (9.1)	9.3 (8.2)	10.7 (9.2)
Week 0: PD1+ TEMRA TREG	22.5 (19.0)	23.5 (17.5)	19.8 (15.0)	19.5 (13.5)
Week 54: PD1+ TEMRA TREG	20.5 (13.7)	19.7 (16.2)	18.6 (14.0)	21.4 (13.9)
Week 80: PD1+ TEMRA TREG	22.5 (15.0)	25.7 (19.5)	22.4 (16.6)	22.7 (13.0)
Week 0: PD1+ TREG CM	16.8 (10.0)	17.5 (11.5)	17.3 (11.0)	17.2 (10.2)
Week 54: PD1+ TREG CM	16.5 (10.5)	16.7 (10.9)	16.8 (11.4)	18.0 (10.6)
Week 80: PD1+ TREG CM	18.1 (13.0)	18.7 (11.2)	16.6 (11.0)	18.8 (11.6)
Week 0: PD1+ TREG EM	20.1 (9.9)	21.1 (11.4)	21.6 (10.9)	20.9 (10.0)
Week 54: PD1+ TREG EM	19.3 (10.5)	19.8 (10.3)	21.1 (11.6)	21.6 (10.7)
Week 80: PD1+ TREG EM	20.6 (12.2)	21.1 (10.5)	19.4 (10.6)	21.9 (10.0)
Week 0: PD1+ICOSNeg cTfh1	30.0 (14.8)	28.8 (15.3)	32.4 (16.5)	29.7 (13.2)
Week 54: PD1+ICOSNeg cTfh1	30.5 (16.2)	29.1 (13.9)	34.2 (19.0)	31.0 (13.5)
Week 80: PD1+ICOSNeg cTfh1	32.4 (18.1)	30.7 (16.0)	31.3 (14.0)	32.8 (13.6)
Week 0: PD1+ICOSNeg cTfh17	21.8 (16.3)	22.5 (16.3)	23.7 (17.1)	22.3 (15.7)
Week 54: PD1+ICOSNeg cTfh17	21.8 (17.4)	21.1 (16.9)	26.2 (19.7)	21.7 (15.5)
Week 80: PD1+ICOSNeg cTfh17	26.8 (19.2)	24.7 (16.0)	23.6 (15.8)	24.3 (15.5)
Week 0: PD1+ICOSNeg cTfh2	19.1 (12.0)	18.4 (12.6)	20.8 (14.3)	18.5 (11.2)
Week 54: PD1+ICOSNeg cTfh2	18.4 (13.3)	18.1 (13.1)	20.2 (14.4)	18.8 (11.7)
Week 80: PD1+ICOSNeg cTfh2	20.2 (16.6)	19.6 (13.9)	18.9 (11.7)	20.2 (13.2)
Week 0: PD1- ICOS- cTfh1	68.4 (15.1)	69.0 (16.3)	64.6 (17.9)	68.9 (13.5)
Week 54: PD1- ICOS- cTfh1	68.6 (16.4)	68.0 (16.5)	64.1 (19.7)	67.5 (14.1)
Week 80: PD1- ICOS- cTfh1	66.7 (18.2)	68.1 (16.1)	67.4 (14.4)	65.9 (14.0)
Week 0: PD1- ICOS- cTfh17	75.6 (18.8)	74.7 (18.2)	73.4 (19.3)	75.3 (18.1)
Week 54: PD1- ICOS- cTfh17	77.4 (17.9)	72.9 (23.7)	70.9 (21.5)	73.5 (20.9)
Week 80: PD1- ICOS- cTfh17	72.1 (20.1)	74.0 (16.2)	73.6 (18.7)	74.6 (15.8)
Week 0: PD1- ICOS- cTfh2	80.1 (12.2)	80.8 (12.8)	78.3 (14.2)	80.7 (11.5)
Week 54: PD1- ICOS- cTfh2	81.0 (13.3)	81.3 (13.3)	78.8 (14.3)	80.3 (11.9)
Week 80: PD1- ICOS- cTfh2	79.1 (16.9)	79.8 (13.9)	80.4 (11.9)	79.0 (13.4)
Week 0: Potentially Anergic TEMRA CD4	0.7 (2.5)	0.2 (0.3)	0.4 (1.0)	0.3 (0.7)
Week 54: Potentially Anergic TEMRA CD4	0.8 (3.0)	0.2 (0.3)	0.5 (1.3)	0.3 (0.5)
Week 80: Potentially Anergic TEMRA CD4	0.8 (2.9)	0.2 (0.3)	0.5 (1.4)	0.3 (0.7)
Week 0: Regulatory T-Follicular Subset	0.2 (0.2)	0.2 (0.2)	0.2 (0.2)	0.2 (0.2)
Week 54: Regulatory T-Follicular Subset	0.2 (0.2)	0.2 (0.2)	0.2 (0.2)	0.3 (0.2)
Week 80: Regulatory T-Follicular Subset	0.2 (0.2)	0.2 (0.3)	0.2 (0.3)	0.3 (0.3)
Week 0: TH17-Like Circulating T-Follicular cells	0.5 (0.5)	0.4 (0.4)	0.5 (0.5)	0.5 (0.5)
Week 54: TH17-Like Circulating T-Follicular cells	0.4 (0.4)	0.4 (0.4)	0.4 (0.5)	0.4 (0.4)
Week 80: TH17-Like Circulating T-Follicular cells	0.4 (0.5)	0.4 (0.5)	0.3 (0.3)	0.4 (0.5)
Week 0: TH2-Like Circulating T-Follicular Cells	3.6 (2.2)	3.6 (2.0)	4.0 (2.0)	4.1 (2.3)
Week 54: TH2-Like Circulating T-Follicular Cells	3.9 (2.0)	3.6 (2.2)	4.0 (2.3)	3.9 (2.5)
Week 80: TH2-Like Circulating T-Follicular Cells	3.8 (2.0)	3.7 (2.1)	3.9 (2.2)	3.8 (2.1)
Week 0: TIGIT+ cTfh1	53.0 (11.6)	48.5 (13.9)	53.4 (12.4)	51.6 (13.1)
Week 54: TIGIT+ cTfh1	51.1 (13.1)	47.6 (13.9)	52.2 (14.1)	50.2 (14.1)
Week 80: TIGIT+ cTfh1	51.4 (11.1)	48.1 (14.4)	49.6 (10.4)	52.7 (12.2)
Week 0: TIGIT+ cTfh17	40.5 (16.2)	36.2 (13.1)	39.3 (14.5)	38.7 (14.9)
Week 54: TIGIT+ cTfh17	37.0 (13.5)	31.4 (16.5)	40.7 (14.7)	35.8 (15.6)
Week 80: TIGIT+ cTfh17	39.4 (14.5)	35.9 (13.9)	35.3 (12.7)	36.8 (13.8)
Week 0: TIGIT+ cTfh2	44.4 (9.5)	40.9 (9.8)	44.8 (7.4)	43.4 (9.8)
Week 54: TIGIT+ cTfh2	41.1 (11.0)	37.9 (10.9)	42.0 (9.6)	41.0 (11.6)
Week 80: TIGIT+ cTfh2	40.7 (10.4)	38.4 (9.5)	40.5 (8.4)	41.9 (9.9)
Week 0: TOTAL ICOS+ TREG	8.6 (4.4)	9.6 (5.5)	8.0 (3.8)	8.9 (4.5)
Week 54: TOTAL ICOS+ TREG	8.3 (4.8)	7.5 (3.5)	7.6 (3.8)	8.6 (3.6)
Week 80: TOTAL ICOS+ TREG	8.3 (4.4)	7.4 (3.6)	6.6 (3.3)	8.6 (3.6)
Week 0: Th1-Like Circulating T-Follicular Cells	1.3 (1.4)	1.3 (1.2)	1.6 (1.2)	1.5 (1.3)
Week 54: Th1-Like Circulating T-Follicular Cells	1.4 (1.2)	1.6 (1.7)	1.8 (1.5)	1.8 (1.9)
Week 80: Th1-Like Circulating T-Follicular Cells	1.5 (1.4)	1.8 (1.9)	1.9 (2.0)	1.6 (1.5)
Week 0: Total PD1+ TREG	14.5 (7.9)	15.1 (8.2)	14.7 (8.9)	14.4 (7.4)
Week 54: Total PD1+ TREG	14.8 (9.1)	14.3 (8.5)	14.5 (9.1)	15.0 (7.6)
Week 80: Total PD1+ TREG	16.0 (10.6)	15.9 (8.3)	14.2 (9.0)	16.1 (8.9)

100. Secondary Outcome

Title	Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel
Description	Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE_MDSC refers to Immature myeloid cells & a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0: CD14+ HLA low Myeloid Cells	1.1 (1.5)	1.0 (1.3)	0.9 (1.2)	1.0 (1.4)
Week 54: CD14+ HLA low Myeloid Cells	1.1 (2.3)	0.7 (0.9)	0.7 (1.1)	0.6 (1.1)
Week 80: CD14+ HLA low Myeloid Cells	1.0 (2.2)	0.6 (0.7)	0.9 (1.2)	0.8 (1.1)
Week 0: CD14+ MDSC	68.2 (20.8)	69.1 (22.3)	73.5 (19.4)	70.3 (18.6)
Week 54: CD14+ MDSC	64.0 (23.4)	67.0 (23.2)	69.3 (21.4)	65.9 (20.2)
Week 80: CD14+ MDSC	65.7 (22.3)	62.7 (20.8)	64.1 (23.3)	63.9 (23.2)
Week 0: CD14-HLA II- Myeloid Cells Total Myeloid	80.4 (11.0)	82.2 (10.4)	80.8 (12.1)	81.8 (11.0)
Week 54: CD14-HLA II- Myeloid Cells Total Myeloid	80.9 (11.7)	80.0 (12.0)	80.8 (12.7)	83.5 (10.5)
Week 80: CD14-HLA II- Myeloid Cells Total Myeloid	79.0 (12.9)	81.0 (10.8)	80.9 (9.7)	81.3 (8.4)
Week 0: CD16+ Dendritic Cells	12.5 (8.4)	11.3 (7.5)	12.9 (10.6)	11.5 (7.5)
Week 54: CD16+ Dendritic Cells	10.2 (8.1)	10.3 (7.5)	11.2 (9.7)	12.0 (9.7)
Week 80: CD16+ Dendritic Cells	11.7 (10.6)	9.4 (6.1)	9.2 (7.1)	12.1 (8.0)
Week 0: IMMYE_MDSC	0.3 (0.2)	0.2 (0.2)	0.2 (0.2)	0.2 (0.4)
Week 54: IMMYE_MDSC	0.2 (0.3)	0.2 (0.3)	0.2 (0.3)	0.1 (0.2)
Week 80: IMMYE_MDSC	0.2 (0.3)	0.1 (0.2)	0.2 (0.2)	0.2 (0.2)
Week 0: Intermediate Monocyte Subset	8.6 (8.4)	9.0 (7.8)	8.3 (8.8)	7.7 (7.3)
Week 54: Intermediate Monocyte Subset	6.5 (4.8)	7.3 (6.7)	6.3 (7.1)	5.8 (5.4)
Week 80: Intermediate Monocyte Subset	6.0 (5.1)	6.6 (6.5)	5.7 (5.4)	5.8 (4.5)
Week 0: Non-Classical Monocytes	1.5 (1.3)	1.3 (0.8)	1.2 (0.8)	1.3 (1.0)
Week 54: Non-Classical Monocytes	1.2 (1.1)	1.3 (0.8)	1.1 (0.8)	1.2 (0.9)
Week 80: Non-Classical Monocytes	1.2 (0.7)	1.2 (0.7)	1.0 (0.6)	1.3 (0.9)
Week 0: Total Classical Monocytes	87.2 (9.3)	86.7 (8.1)	87.6 (9.1)	88.0 (8.0)
Week 54: Total Classical Monocytes	87.8 (7.9)	88.1 (7.6)	88.0 (8.8)	89.3 (6.8)
Week 80: Total Classical Monocytes	89.3 (6.0)	88.5 (7.1)	88.6 (7.0)	89.7 (5.4)
Week 0: Total Monocytes in Myeloid Cells	14.2 (8.9)	12.6 (7.8)	14.1 (9.5)	13.4 (8.7)
Week 54: Total Monocytes in Myeloid Cells	13.8 (9.3)	14.9 (9.8)	14.3 (10.6)	12.2 (8.3)
Week 80: Total Monocytes in Myeloid Cells	15.5 (10.3)	13.8 (9.1)	13.6 (7.6)	13.5 (6.3)
Week 0: Total Myeloid DC	3.8 (2.1)	3.6 (2.3)	3.8 (2.8)	3.4 (2.0)
Week 54: Total Myeloid DC	3.7 (2.3)	3.9 (2.4)	3.8 (2.4)	3.2 (2.1)
Week 80: Total Myeloid DC	4.1 (2.3)	4.1 (2.5)	4.1 (3.0)	3.9 (2.1)
Week 0: Total MYDC	30.4 (9.1)	31.4 (10.2)	32.7 (9.2)	31.0 (9.6)
Week 54: Total MYDC	30.4 (11.3)	31.3 (8.5)	31.7 (11.9)	27.2 (9.2)
Week 80: Total MYDC	28.7 (10.7)	30.5 (7.9)	31.6 (12.0)	31.9 (10.2)
Week 0: Total Percent Of Myeloid Cells	94.6 (3.8)	94.7 (5.4)	94.6 (3.4)	94.6 (4.1)
Week 54: Total Percent Of Myeloid Cells	95.1 (3.6)	95.9 (4.0)	95.0 (3.8)	95.6 (3.7)
Week 80: Total Percent Of Myeloid Cells	94.8 (5.4)	95.6 (4.0)	94.6 (4.4)	94.1 (5.1)
Week 0: Total Plasmacytoid Dendritic Cells (PDC)	14.3 (5.4)	12.5 (6.6)	12.0 (6.3)	12.9 (7.5)
Week 54: Total Plasmacytoid Dendritic Cells (PDC)	14.4 (6.7)	13.5 (5.9)	12.0 (6.1)	11.8 (6.5)
Week 80: Total Plasmacytoid Dendritic Cells (PDC)	13.5 (6.6)	12.8 (6.7)	11.6 (6.3)	12.5 (6.7)

101. Secondary Outcome

Title	Autoantibodies Against Glutamic Acid Decarboxylase (GAD)
Description	Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Negative	3 3.9%	1 1.3%	5 6.6%	3 3.9%
Positive	74 96.1%	76 98.7%	71 93.4%	74 96.1%
Negative	5 6.5%	4 5.2%	4 5.3%	3 3.9%
Positive	62 80.5%	61 79.2%	64 84.2%	63 81.8%
Negative	4 5.2%	2 2.6%	5 6.6%	1 1.3%
Positive	61 79.2%	62 80.5%	63 82.9%	61 79.2%

102. Secondary Outcome

Title	Autoantibodies Against Zinc-transporter 8 (ZnT8)
Description	Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Negative	29 37.7%	30 39%	30 39.5%	36 46.8%
Positive	48 62.3%	47 61%	46 60.5%	41 53.2%
Negative	26 33.8%	28 36.4%	27 35.5%	33 42.9%
Positive	42 54.5%	37 48.1%	41 53.9%	33 42.9%
Negative	23 29.9%	30 39%	31 40.8%	33 42.9%
Positive	42 54.5%	34 44.2%	37 48.7%	29 37.7%

103. Secondary Outcome

Title	Autoantibodies Against Islet Antigen-2 (IA2)
Description	Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Negative	38 49.4%	37 48.1%	31 40.8%	45 58.4%
Positive	39 50.6%	40 51.9%	45 59.2%	32 41.6%
Negative	35 45.5%	33 42.9%	28 36.8%	38 49.4%
Positive	33 42.9%	32 41.6%	40 52.6%	28 36.4%
Negative	32 41.6%	38 49.4%	29 38.2%	35 45.5%
Positive	33 42.9%	26 33.8%	39 51.3%	27 35.1%

104. Secondary Outcome

Title	Autoantibodies Against Insulin Autoantibodies (IAA)
Description	Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Negative	35 45.5%	28 36.4%	26 34.2%	36 46.8%
Positive	42 54.5%	48 62.3%	49 64.5%	40 51.9%
Negative	30 39%	28 36.4%	22 28.9%	11 14.3%
Positive	38 49.4%	37 48.1%	46 60.5%	55 71.4%
Negative	18 23.4%	24 31.2%	13 17.1%	15 19.5%
Positive	48 62.3%	40 51.9%	55 72.4%	47 61%

105. Secondary Outcome

Title	Change in Biomarker: Total Interleukin-21 (IL-21)
Description	IL-21 is evaluated at baseline (week 0), week 54 and week 80.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0	28.8 (10.2)	31.1 (10.8)	30.9 (10.7)	30.2 (10.2)
Week 54	3993.5 (2145.4)	4368.2 (2374.9)	25.0 (0.0)	34.1 (68.1)
Week 80	540.9 (495.3)	674.1 (648.1)	28.0 (8.2)	30.7 (17.2)

106. Secondary Outcome

Title	Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)
Description	Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.
Time Frame	Week 0, week 54 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 0	123 (30)	122 (39)	122 (29)	120 (33)
Week 54	117 (31)	125 (36)	113 (30)	119 (32)
Week 80	119 (41)	124 (49)	121 (38)	115 (33)

107. Secondary Outcome

Title	Change in Short Form 36 Health Survey (SF-36)
Description	SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 54: Bodily pain	-0.8 (8.5)	-2.2 (7.6)	0.1 (5.2)	0.6 (9.1)
Week 80: Bodily Pain	0.8 (7.8)	-1.4 (7.0)	-0.5 (6.4)	0.8 (10.2)
Week 54: General Health Perception	-1.1 (7.1)	-0.3 (8.4)	-1.6 (7.3)	-1.0 (7.1)
Week 80: General Health Perception	-0.9 (7.2)	0.6 (9.0)	-1.7 (7.9)	-1.8 (8.6)
Week 54: Mental Component Sum	0.5 (9.4)	0.6 (9.3)	-2.1 (9.0)	-1.3 (7.6)
Week 80: Mental Component Sum	1.7 (9.8)	-0.4 (8.9)	-2.4 (9.6)	-0.7 (8.7)
week 54: Mental Health	0.7 (8.4)	0.6 (7.9)	-1.5 (8.6)	-1.3 (6.9)
Week 80: Mental Health	1.5 (8.6)	-0.2 (8.0)	-1.5 (9.0)	-0.7 (7.6)
Week 54: Physical Component Sum	-0.4 (4.2)	-0.4 (5.3)	-0.1 (3.8)	0.3 (5.7)
Week 80: Physical Component Sum	-0.1 (3.9)	0.5 (5.4)	0.0 (4.3)	0.0 (6.9)
Week 54: Physical Functioning	0.6 (2.5)	0.9 (4.4)	0.0 (2.6)	0.3 (5.8)
Week 80: Physical Functioning	0.5 (2.9)	1.1 (4.6)	-0.1 (2.4)	0.1 (6.4)
Week 54:Lim Emotion Prob	0.3 (10.7)	0.5 (8.9)	-1.4 (9.0)	-0.1 (8.5)
Week 80: Lim Emotion Prob	1.2 (10.8)	-0.1 (9.8)	-2.2 (9.4)	0.0 (8.3)
Week 54: Lim. Phy Health	0.3 (5.8)	0.7 (6.9)	-0.6 (5.7)	-0.2 (6.9)
Week 80: Lim. Phy Health	0.8 (6.4)	0.9 (7.0)	-0.2 (5.2)	0.0 (7.3)
Week 54: Social Functioning	0.8 (10.3)	0.1 (10.0)	-1.4 (7.4)	0.0 (8.5)
Week 80: Social Functioning	2.3 (9.9)	1.0 (8.3)	-1.2 (7.3)	-0.4 (8.4)
Week 54: Vitality	-0.5 (8.2)	0.5 (7.9)	-2.2 (5.9)	-2.3 (6.9)
Week 80: Vitality	0.5 (7.9)	-1.4 (6.9)	-2.2 (7.1)	-0.7 (6.9)

108. Secondary Outcome

Title	Change in Experience of Treatment Benefits and Barriers (ETBB)
Description	Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 54: Total Score for Perceived Barriers	-1.2 (8.3)	-1.8 (7.7)	-0.2 (8.2)	-0.3 (6.3)
Week 80: Total Score for Perceived Barriers	-2.0 (7.8)	-2.0 (7.5)	-0.1 (6.7)	0.1 (8.3)
Week 54: Total Score for Perceived Benefits	0.6 (5.6)	1.1 (4.2)	0.2 (5.7)	-0.5 (6.3)
Week 80: Total Score for Perceived Benefits	0.1 (5.8)	1.1 (4.8)	1.3 (6.2)	-0.4 (5.1)

109. Secondary Outcome

Title	Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Description	Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.
Time Frame	(Week 0, week 54) and (week 0, week 80)

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Number analyzed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	77	77	76	77
Week 54: Perceived frequency of hyperglycaemia	0.6 (1.9)	0.0 (1.5)	0.0 (1.9)	0.5 (1.7)
Week 80: Perceived frequency of hyperglycaemia	0.9 (1.8)	0.5 (1.8)	0.6 (2.0)	0.7 (1.9)
Week 54: Perceived frequency of hypoglycaemia	-0.7 (2.1)	-0.6 (1.6)	-0.4 (2.1)	-0.2 (1.5)
Week 80: Perceived frequency of hypoglycaemia	-0.9 (1.8)	-0.3 (1.7)	-0.4 (1.8)	-0.1 (1.5)
Week 54: Treatment satisfaction	1.5 (4.8)	0.9 (5.2)	1.3 (4.8)	0.2 (5.5)
Week 80: Treatment satisfaction	1.3 (6.1)	1.2 (5.7)	0.0 (5.1)	0.2 (6.2)

110. Secondary Outcome

Title	Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).
Time Frame	0 - 4 hours post-dose on week 0 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	63	64	62	58
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	0.566 (71.3)	0.598 (70.2)	0.373 (115.8)	0.571 (100.9)

111. Secondary Outcome

Title	AUC0-2h of C-peptide at Week 80 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.
Time Frame	0-2 hours post-dose on week 0 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	63	64	62	58
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	0.590 (74.5)	0.619 (71.2)	0.370 (111.5)	0.540 (120.6)

112. Secondary Outcome

Title	Cmax of C-peptide at Week 80 Relative to Baseline
Description	Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).
Time Frame	0-4 hours post-dose on week 0 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	63	64	62	58
Geometric Mean (Geometric Coefficient of Variation) [Ratio of Cmax]	0.580 (74.8)	0.592 (76.8)	0.389 (109.0)	0.568 (97.7)

113. Secondary Outcome

Title	AUC0-4h of Glucose at Week 80 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).
Time Frame	0 - 4 hours post-dose on week 0 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	63	64	63	58
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	1.129 (33.3)	1.115 (32.6)	1.136 (39.0)	1.221 (26.6)

114. Secondary Outcome

Title	AUC0-2h of Glucose at Week 80 Relative to Baseline
Description	Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol*h/L'.
Time Frame	0-2 hours post-dose on week 0 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	63	64	63	58
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AUC]	1.119 (28.6)	1.086 (28.1)	1.070 (35.5)	1.166 (21.7)

115. Secondary Outcome

Title	Cmax of Glucose at Week 80 Relative to Baseline
Description	Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.
Time Frame	0-4 hours post-dose on week 0 and week 80

Outcome Measure Data

Analysis Population Description

The FAS included all randomised participants. Overall number of participants analysed = participants with available data

Arm/Group Title	NNC0114-0006 + Liraglutide (Experimental)	NNC0114-0006 (Experimental)	Liraglutide (Experimental)	Placebo (Placebo)
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Measure Participants	63	64	63	58
Geometric Mean (Geometric Coefficient of Variation) [Ratio of Cmax]	1.114 (25.6)	1.074 (28.7)	1.104 (31.0)	1.155 (21.5)

Adverse Events

Time Frame	Weeks 0-80
Adverse Event Reporting Description	All reported adverse events are treatment-emergent. Results are based on the safety analysis set (SAS) which included all participants who received at least one dose of randomised treatment.
Arm/Group Title	NNC0114-0006 + Liraglutide		NNC0114-0006		Liraglutide		Placebo
Arm/Group Description	Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.		Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.		Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.		Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
All Cause Mortality
	NNC0114-0006 + Liraglutide		NNC0114-0006		Liraglutide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)		1/76 (1.3%)		0/77 (0%)
Serious Adverse Events
	NNC0114-0006 + Liraglutide		NNC0114-0006		Liraglutide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/77 (9.1%)		5/77 (6.5%)		9/76 (11.8%)		11/77 (14.3%)
Blood and lymphatic system disorders
Haemorrhagic anaemia	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Lymphoid tissue hyperplasia	1/77 (1.3%)	1	0/77 (0%)	0	0/76 (0%)	0	0/77 (0%)	0
Cardiac disorders
Atrioventricular block second degree	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Myocarditis	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Congenital, familial and genetic disorders
Spinal muscular atrophy	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Gastrointestinal disorders
Abdominal pain	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Vomiting	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Infections and infestations
Bronchitis	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Genital herpes	0/77 (0%)	0	1/77 (1.3%)	1	0/76 (0%)	0	0/77 (0%)	0
Genital herpes simplex	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Herpes zoster	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Meningitis	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Oral herpes	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	2	0/77 (0%)	0
Peritonsillitis	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Pneumonia	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Tooth abscess	1/77 (1.3%)	1	0/77 (0%)	0	0/76 (0%)	0	0/77 (0%)	0
Injury, poisoning and procedural complications
Clavicle fracture	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Concussion	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	1/77 (1.3%)	1
Contusion	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Head injury	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Limb injury	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Lower limb fracture	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Meniscus injury	1/77 (1.3%)	1	0/77 (0%)	0	0/76 (0%)	0	0/77 (0%)	0
Pulmonary contusion	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Traumatic shock	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Wrist fracture	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Investigations
Cytomegalovirus test positive	1/77 (1.3%)	1	0/77 (0%)	0	0/76 (0%)	0	0/77 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus	1/77 (1.3%)	1	0/77 (0%)	0	0/76 (0%)	0	0/77 (0%)	0
Diabetes mellitus inadequate control	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Diabetic ketoacidosis	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	1/77 (1.3%)	1
Diabetic metabolic decompensation	2/77 (2.6%)	2	0/77 (0%)	0	1/76 (1.3%)	1	2/77 (2.6%)	2
Hypoglycaemia	1/77 (1.3%)	1	1/77 (1.3%)	1	0/76 (0%)	0	0/77 (0%)	0
Ketosis	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Nervous system disorders
Brain oedema	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Headache	1/77 (1.3%)	1	0/77 (0%)	0	0/76 (0%)	0	0/77 (0%)	0
Hypoglycaemic coma	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Hypoglycaemic unconsciousness	0/77 (0%)	0	1/77 (1.3%)	1	0/76 (0%)	0	0/77 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1
Psychiatric disorders
Suicide attempt	0/77 (0%)	0	1/77 (1.3%)	1	0/76 (0%)	0	0/77 (0%)	0
Reproductive system and breast disorders
Cervical dysplasia	0/77 (0%)	0	1/77 (1.3%)	1	0/76 (0%)	0	0/77 (0%)	0
Respiratory, thoracic and mediastinal disorders
Nasal polyps	0/77 (0%)	0	1/77 (1.3%)	1	0/76 (0%)	0	0/77 (0%)	0
Nasal septum deviation	0/77 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/77 (0%)	0
Surgical and medical procedures
Routine health maintenance	1/77 (1.3%)	1	0/77 (0%)	0	0/76 (0%)	0	0/77 (0%)	0
Other (Not Including Serious) Adverse Events
	NNC0114-0006 + Liraglutide		NNC0114-0006		Liraglutide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	57/77 (74%)		55/77 (71.4%)		62/76 (81.6%)		54/77 (70.1%)
Gastrointestinal disorders
Abdominal discomfort	2/77 (2.6%)	2	4/77 (5.2%)	5	4/76 (5.3%)	4	2/77 (2.6%)	4
Abdominal distension	3/77 (3.9%)	3	0/77 (0%)	0	4/76 (5.3%)	4	0/77 (0%)	0
Abdominal pain	9/77 (11.7%)	11	0/77 (0%)	0	4/76 (5.3%)	4	7/77 (9.1%)	10
Abdominal pain upper	1/77 (1.3%)	1	0/77 (0%)	0	7/76 (9.2%)	8	4/77 (5.2%)	6
Diarrhoea	15/77 (19.5%)	21	9/77 (11.7%)	15	13/76 (17.1%)	22	9/77 (11.7%)	11
Dyspepsia	5/77 (6.5%)	8	3/77 (3.9%)	6	3/76 (3.9%)	5	4/77 (5.2%)	4
Nausea	19/77 (24.7%)	33	6/77 (7.8%)	10	42/76 (55.3%)	62	9/77 (11.7%)	13
Vomiting	14/77 (18.2%)	24	0/77 (0%)	0	17/76 (22.4%)	34	4/77 (5.2%)	5
General disorders
Fatigue	4/77 (5.2%)	4	4/77 (5.2%)	4	6/76 (7.9%)	6	2/77 (2.6%)	4
Pyrexia	3/77 (3.9%)	4	7/77 (9.1%)	9	7/76 (9.2%)	12	4/77 (5.2%)	4
Infections and infestations
Gastroenteritis	3/77 (3.9%)	4	6/77 (7.8%)	7	5/76 (6.6%)	6	4/77 (5.2%)	5
Influenza	6/77 (7.8%)	7	12/77 (15.6%)	14	2/76 (2.6%)	3	2/77 (2.6%)	2
Nasopharyngitis	20/77 (26%)	35	27/77 (35.1%)	63	25/76 (32.9%)	50	25/77 (32.5%)	45
Pharyngitis	3/77 (3.9%)	3	4/77 (5.2%)	5	0/76 (0%)	0	3/77 (3.9%)	4
Respiratory tract infection viral	5/77 (6.5%)	7	1/77 (1.3%)	1	3/76 (3.9%)	6	2/77 (2.6%)	2
Rhinitis	5/77 (6.5%)	5	3/77 (3.9%)	3	3/76 (3.9%)	5	5/77 (6.5%)	6
Sinusitis	1/77 (1.3%)	1	2/77 (2.6%)	5	1/76 (1.3%)	1	4/77 (5.2%)	4
Upper respiratory tract infection	8/77 (10.4%)	13	5/77 (6.5%)	9	4/76 (5.3%)	4	7/77 (9.1%)	9
Injury, poisoning and procedural complications
Contusion	4/77 (5.2%)	5	1/77 (1.3%)	2	0/76 (0%)	0	3/77 (3.9%)	3
Skin laceration	0/77 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	4/77 (5.2%)	4
Investigations
Blood creatine phosphokinase increased	4/77 (5.2%)	4	2/77 (2.6%)	2	2/76 (2.6%)	2	3/77 (3.9%)	3
Blood immunoglobulin E increased	1/77 (1.3%)	1	3/77 (3.9%)	3	7/76 (9.2%)	7	4/77 (5.2%)	5
Lipase increased	5/77 (6.5%)	6	1/77 (1.3%)	1	1/76 (1.3%)	1	2/77 (2.6%)	2
Weight decreased	4/77 (5.2%)	4	2/77 (2.6%)	2	1/76 (1.3%)	1	0/77 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	14/77 (18.2%)	15	2/77 (2.6%)	2	11/76 (14.5%)	13	1/77 (1.3%)	1
Hypoglycaemia	4/77 (5.2%)	15	1/77 (1.3%)	1	0/76 (0%)	0	0/77 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	4/77 (5.2%)	4	1/77 (1.3%)	1	1/76 (1.3%)	1	3/77 (3.9%)	3
Back pain	1/77 (1.3%)	1	4/77 (5.2%)	6	5/76 (6.6%)	6	2/77 (2.6%)	3
Nervous system disorders
Headache	11/77 (14.3%)	21	10/77 (13%)	12	10/76 (13.2%)	11	11/77 (14.3%)	17
Respiratory, thoracic and mediastinal disorders
Cough	6/77 (7.8%)	7	4/77 (5.2%)	4	5/76 (6.6%)	7	1/77 (1.3%)	1
Oropharyngeal pain	10/77 (13%)	11	13/77 (16.9%)	18	5/76 (6.6%)	8	9/77 (11.7%)	11
Respiratory disorder	4/77 (5.2%)	4	2/77 (2.6%)	2	0/76 (0%)	0	5/77 (6.5%)	6
Rhinorrhoea	1/77 (1.3%)	1	0/77 (0%)	0	2/76 (2.6%)	4	4/77 (5.2%)	6
Skin and subcutaneous tissue disorders
Erythema	1/77 (1.3%)	1	0/77 (0%)	0	1/76 (1.3%)	1	4/77 (5.2%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.