Ellipse™: Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01541215
• Collaborator: (none)
• Enrollment: 135
• Locations: 185
• Arms: 2
• Actual Duration (Months): 90.2
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: liraglutide; Drug: placebo; Drug: metformin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
• Actual Study Start Date: Nov 13, 2012
• Actual Primary Completion Date: Nov 15, 2017
• Actual Study Completion Date: May 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lira + Met	Drug: liraglutide; Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.; Drug: metformin; Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
Placebo Comparator: Placebo + Met	Drug: placebo; Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.; Drug: metformin; Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c (Glycosylated Haemoglobin) [Week 0, week 26]

   Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.

Secondary Outcome Measures

1. Change From Baseline in Fasting Plasma Glucose (FPG) [Week 0, week 26]

   Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.

2. Number of Subjects Having HbA1c Below 7.0% [Week 26]

   Percentage of subjects having HbA1c <7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

3. Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) [Week 0, week 26]

   Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

4. Number of Subjects Having HbA1c Below 7.0% [Week 52]

   Number of subjects achieving HbA1c <7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

5. Number of Subjects Having HbA1c Maximum 6.5% [Week 26]

   Number of subjects achieving HbA1c <=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

6. Number of Subjects Having HbA1c Maximum 6.5% [Week 52]

   Number of subjects achieving HbA1c <=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

7. Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes [Week 26]

   Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 26 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

8. Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes [Week 52]

   Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 52 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

9. Number of Subjects Having HbA1c Below 7.5% [Week 26]

   Number of subjects achieving HbA1c <7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

10. Number of Subjects Having HbA1c Below 7.5% [Week 52]

    Number of subjects achieving HbA1c <7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

11. Change in HbA1c [Week 0, week 52]

    Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.

12. Change in FPG [Week 0, week 52]

    Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.

13. Change in Mean 7-point Self-measured Plasma Glucose [Week 0, week 26]

    Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: 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. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

14. Change From Baseline in 7-point Self-measured Plasma Glucose [Week 0, week 52]

    Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: 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. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

15. Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) [Week 0, week 26]

    Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

16. Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) [Week 0, week 52]

    Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

17. Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) [Week 0, week 26]

    Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

18. Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) [Week 0, week 52]

    Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

19. Change From Baseline in Body Weight [Week 0, week 26]

    Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

20. Change From Baseline in Body Weight [Week 0, week 52]

    Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

21. Change From Baseline in BMI Standard Deviation Score (SDS) [Week 0, week 52]

    Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

22. Change in Blood Pressure (Systolic and Diastolic Blood Pressure) [Week 0, week 26]

    Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

23. Change in Blood Pressure (Systolic and Diastolic Blood Pressure) [Week 0, week 52]

    Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

24. Ratio to Baseline: Fasting Insulin [Week 0, week 26]

    Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

25. Ratio to Baseline: Fasting Insulin [Week 0, week 52]

    Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

26. Ratio to Baseline: Fasting Pro-insulin [Week 0, week 26]

    Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

27. Ratio to Baseline: Fasting Pro-insulin [Week 0, week 52]

    Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

28. Ratio to Baseline: Pro-insulin/Insulin Ratio [Week 0, week 26]

    Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

29. Ratio to Baseline: Pro-insulin/Insulin Ratio [Week 0, week 52]

    Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

30. Ratio to Baseline: Fasting Glucagon [Week 0, week 26]

    Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

31. Ratio to Baseline: Fasting Glucagon [Week 0, week 52]

    Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

32. Ratio to Baseline: Fasting C-peptide [Week 0, week 26]

    Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

33. Ratio to Baseline: Fasting C-peptide [Week 0, week 52]

    Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

34. Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) [Week 0, week 26]

    Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

35. Ratio to Baseline: HOMA-B [Week 0, week 52]

    Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

36. Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) [Week 0, week 26]

    Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

37. Ratio to Baseline: HOMA-IR [Week 0, week 52]

    Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

38. Ratio to Baseline: Total Cholesterol [Week 0, week 26]

    Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

39. Ratio to Baseline: Total Cholesterol [Week 0, week 52]

    Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

40. Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol [Week 0, week 26]

    Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

41. Ratio to Baseline: LDL Cholesterol [Week 0, week 52]

    Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

42. Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol [Week 0, week 26]

    Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

43. Ratio to Baseline: VLDL Cholesterol [Week 0, week 52]

    Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

44. Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol [Week 0, week 26]

    Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

45. Ratio to Baseline: HDL Cholesterol [Week 0, week 52]

    Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

46. Ratio to Baseline: Triglycerides [Week 0, week 26]

    Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

47. Ratio to Baseline: Triglycerides [Week 0, week 52]

    Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

48. Ratio to Baseline: Free Fatty Acids [Week 0, week 26]

    Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

49. Ratio to Baseline: Free Fatty Acids [Week 0, week 52]

    Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

50. Change From Baseline in Pulse [Week 0, week 26]

    Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

51. Change From Baseline in Pulse [Week 0, week 52]

    Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

52. Change From Baseline in Height SDS [Week 0, week 26]

    Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

53. Change From Baseline in Height SDS [Week 0, week 52]

    Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

54. Change in Bone Age Assessment (X-ray of Left Hand and Wrist) [Week 0, week 52]

    Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.

55. Pubertal Assessment/Progression (Tanner Staging) [Week 0, week 26, week 52]

    Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.

56. Growth (Height Velocity) [Week 0, week 26]

    Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.

57. Growth (Height Velocity) [Week 0, week 52]

    Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.

58. Height Velocity SDS [Week 0, week 26]

    Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

59. Height Velocity SDS [Week 0, week 52]

    Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

60. Number of Hypoglycaemic Episodes [0-26 weeks]

    Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.

61. Number of Hypoglycaemic Episodes [0-52 weeks]

    Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.

62. Number of Adverse Events (Week 0-26) [0-26 weeks]

    Total number of adverse events during 26 weeks.

63. Number of Adverse Events (Week 0-52) [0-52 weeks]

    Total number of adverse events during entire treatment period.

64. Number of Serious Adverse Events (Week 0-26) [0-26 weeks]

    Total number of serious adverse events during 26 weeks.

65. Number of Serious Adverse Events (Week 0-52) [0-52 weeks]

    Total number of serious adverse events during entire treatment period.

66. Number of Adverse Events (Week 53-104) [Week 53-104]

    This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).

67. Number of Serious Adverse Events (Week 53-104) [Weeks 53-104]

    This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).

68. Growth (Height Velocity)- Week 104 [Week 0, week 104]

    Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

69. Height Velocity SDS- Week 104 [Week 0, week 104]

    The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

70. Change From Week 52 in Height SDS- Week 104 [Week 52, week 104]

    Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

71. Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 [Week 52, week 104]

    Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

72. Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104 [Week 52, week 104]

    Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

73. Number of Adverse Events (Week 53-156) [Week 53-156]

    This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).

74. Number of Serious Adverse Events (Week 53-156) [Weeks 53-156]

    This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).

75. Growth (Height Velocity)- Week 156 [Week 0, week 156]

    Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

76. Height Velocity SDS- Week 156 [Week 0, week 156]

    The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

77. Change From Week 52 in Height SDS- Week 156 [Week 52, week 156]

    Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

78. Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 [Week 52, week 156]

    Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

79. Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156 [Week 52, week 156]

    Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: - Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination

• Body mass index (BMI) above 85% percentile of the general age and gender matched population Exclusion Criteria: - Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35233
2	Novo Nordisk Investigational Site	Phoenix	Arizona	United States	85053
3	Novo Nordisk Investigational Site	Tucson	Arizona	United States	85724-0001
4	Novo Nordisk Investigational Site	Corona	California	United States	92880
5	Novo Nordisk Investigational Site	Costa Mesa	California	United States	92626
6	Novo Nordisk Investigational Site	Long Beach	California	United States	90806
7	Novo Nordisk Investigational Site	Los Angeles	California	United States	90027
8	Novo Nordisk Investigational Site	Los Angeles	California	United States	90048-1869
9	Novo Nordisk Investigational Site	Moreno Valley	California	United States	92555
10	Novo Nordisk Investigational Site	Palo Alto	California	United States	94304-1503
11	Novo Nordisk Investigational Site	San Diego	California	United States	92123
12	Novo Nordisk Investigational Site	Ventura	California	United States	93003
13	Novo Nordisk Investigational Site	New Haven	Connecticut	United States	06511
14	Novo Nordisk Investigational Site	Wilmington	Delaware	United States	19803
15	Novo Nordisk Investigational Site	Washington	District of Columbia	United States	20011
16	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32256
17	Novo Nordisk Investigational Site	Melbourne	Florida	United States	32901
18	Novo Nordisk Investigational Site	Miami	Florida	United States	33126
19	Novo Nordisk Investigational Site	Miami	Florida	United States	33144
20	Novo Nordisk Investigational Site	Miami	Florida	United States	33155
21	Novo Nordisk Investigational Site	Saint Petersburg	Florida	United States	33701
22	Novo Nordisk Investigational Site	Tallahassee	Florida	United States	32308
23	Novo Nordisk Investigational Site	Tampa	Florida	United States	33612
24	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30318
25	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30322
26	Novo Nordisk Investigational Site	Columbus	Georgia	United States	31904
27	Novo Nordisk Investigational Site	Bloomington	Indiana	United States	47401
28	Novo Nordisk Investigational Site	Iowa City	Iowa	United States	52242
29	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
30	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
31	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40536-0284
32	Novo Nordisk Investigational Site	Silver Spring	Maryland	United States	20910
33	Novo Nordisk Investigational Site	Worcester	Massachusetts	United States	01655
34	Novo Nordisk Investigational Site	Detroit	Michigan	United States	48201
35	Novo Nordisk Investigational Site	Grand Rapids	Michigan	United States	49503
36	Novo Nordisk Investigational Site	Saint Paul	Minnesota	United States	55102
37	Novo Nordisk Investigational Site	Columbia	Missouri	United States	65201
38	Novo Nordisk Investigational Site	Kansas City	Missouri	United States	64111
39	Novo Nordisk Investigational Site	Saint Louis	Missouri	United States	63104
40	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89128
41	Novo Nordisk Investigational Site	Hackensack	New Jersey	United States	07601
42	Novo Nordisk Investigational Site	West Orange	New Jersey	United States	07052
43	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
44	Novo Nordisk Investigational Site	New York	New York	United States	10003
45	Novo Nordisk Investigational Site	New York	New York	United States	10016
46	Novo Nordisk Investigational Site	New York	New York	United States	10029
47	Novo Nordisk Investigational Site	Sleepy Hollow	New York	United States	10591
48	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45229
49	Novo Nordisk Investigational Site	Toledo	Ohio	United States	43606
50	Novo Nordisk Investigational Site	Hershey	Pennsylvania	United States	17033
51	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
52	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19134
53	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
54	Novo Nordisk Investigational Site	Greenville	South Carolina	United States	29615
55	Novo Nordisk Investigational Site	Rapid City	South Dakota	United States	57701
56	Novo Nordisk Investigational Site	Chattanooga	Tennessee	United States	37403
57	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38105
58	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38119-3821
59	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38119
60	Novo Nordisk Investigational Site	Nashville	Tennessee	United States	37232
61	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
62	Novo Nordisk Investigational Site	Dallas	Texas	United States	75235
63	Novo Nordisk Investigational Site	Edinburg	Texas	United States	78539
64	Novo Nordisk Investigational Site	Fort Worth	Texas	United States	76104
65	Novo Nordisk Investigational Site	Houston	Texas	United States	77054
66	Novo Nordisk Investigational Site	Houston	Texas	United States	77061
67	Novo Nordisk Investigational Site	Kerrville	Texas	United States	78028
68	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78233
69	Novo Nordisk Investigational Site	Charlottesville	Virginia	United States	22908
70	Novo Nordisk Investigational Site	Norfolk	Virginia	United States	23507
71	Novo Nordisk Investigational Site	Charleston	West Virginia	United States	25302
72	Novo Nordisk Investigational Site	Ipswich	Queensland	Australia	4305
73	Novo Nordisk Investigational Site	Graz		Austria	8036
74	Novo Nordisk Investigational Site	Innsbruck		Austria	6020
75	Novo Nordisk Investigational Site	Salzburg		Austria	5020
76	Novo Nordisk Investigational Site	Wels		Austria	4600
77	Novo Nordisk Investigational Site	Brussel		Belgium	1090
78	Novo Nordisk Investigational Site	Bruxelles		Belgium	1200
79	Novo Nordisk Investigational Site	Leuven		Belgium	3000
80	Novo Nordisk Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	91350-250
81	Novo Nordisk Investigational Site	Edmonton	Alberta	Canada	T5X 3N5
82	Novo Nordisk Investigational Site	Winnipeg	Manitoba	Canada	R3E 3P4
83	Novo Nordisk Investigational Site	Brampton	Ontario	Canada	L6T 0G1
84	Novo Nordisk Investigational Site	Westmount	Quebec	Canada	H3Z 1E5
85	Novo Nordisk Investigational Site	Rijeka		Croatia	51000
86	Novo Nordisk Investigational Site	Zagreb		Croatia	10 000
87	Novo Nordisk Investigational Site	Herlev		Denmark	2730
88	Novo Nordisk Investigational Site	Næstved		Denmark	4700
89	Novo Nordisk Investigational Site	Alexandria		Egypt	21131
90	Novo Nordisk Investigational Site	Cairo		Egypt	11562
91	Novo Nordisk Investigational Site	Cairo		Egypt	11628
92	Novo Nordisk Investigational Site	Mansoura		Egypt	35516
93	Novo Nordisk Investigational Site	Marseille		France	13006
94	Novo Nordisk Investigational Site	MONTPELLIER cedex 05		France	34295
95	Novo Nordisk Investigational Site	Ludwigshafen		Germany	67059
96	Novo Nordisk Investigational Site	Mayen		Germany	56727
97	Novo Nordisk Investigational Site	Athens		Greece	151 23
98	Novo Nordisk Investigational Site	Athens		Greece	GR-17562
99	Novo Nordisk Investigational Site	Goudi/ Athens		Greece	GR-11527
100	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54643
101	Novo Nordisk Investigational Site	Budapest		Hungary	1023
102	Novo Nordisk Investigational Site	Budapest		Hungary	1089
103	Novo Nordisk Investigational Site	Budapest		Hungary	1094
104	Novo Nordisk Investigational Site	Miskolc		Hungary	3501
105	Novo Nordisk Investigational Site	Szombathely		Hungary	H-9700
106	Novo Nordisk Investigational Site	Guntur	Andhra Pradesh	India	522001
107	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh	India	500072
108	Novo Nordisk Investigational Site	Bangalore	Karnataka	India	560 017
109	Novo Nordisk Investigational Site	Bangalore	Karnataka	India	560041
110	Novo Nordisk Investigational Site	Bangalore	Karnataka	India	560052
111	Novo Nordisk Investigational Site	Bangalore	Karnataka	India	560054
112	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	400008
113	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	400703
114	Novo Nordisk Investigational Site	Pune	Maharashtra	India	411001
115	Novo Nordisk Investigational Site	New Dehli	New Delhi	India	110029
116	Novo Nordisk Investigational Site	Chandigarh	Punjab	India	160012
117	Novo Nordisk Investigational Site	Ludhiana	Punjab	India	141001
118	Novo Nordisk Investigational Site	Jaipur	Rajasthan	India	302006
119	Novo Nordisk Investigational Site	Chennai	Tamil Nadu	India	600086
120	Novo Nordisk Investigational Site	Hyderbad	Telengana	India	500 012
121	Novo Nordisk Investigational Site	Kolkata	West Bengal	India	700020
122	Novo Nordisk Investigational Site	Kolkata		India	700017
123	Novo Nordisk Investigational Site	Beer Sheva		Israel	84101
124	Novo Nordisk Investigational Site	Haifa		Israel	31096
125	Novo Nordisk Investigational Site	Jerusalem		Israel	91240
126	Novo Nordisk Investigational Site	Petah Tikva		Israel	49202
127	Novo Nordisk Investigational Site	Tel Hashomer		Israel	52621
128	Novo Nordisk Investigational Site	Roma		Italy	00165
129	Novo Nordisk Investigational Site	Hazmieh		Lebanon	9615
130	Novo Nordisk Investigational Site	Lebanon - Beirut		Lebanon	9611
131	Novo Nordisk Investigational Site	Kuala Lumpur		Malaysia	59100
132	Novo Nordisk Investigational Site	Tampico	Tamaulipas	Mexico	89170
133	Novo Nordisk Investigational Site	Puebla		Mexico	72190
134	Novo Nordisk Investigational Site	Fès		Morocco	30000
135	Novo Nordisk Investigational Site	Rabat		Morocco	10000
136	Novo Nordisk Investigational Site	Den Bosch		Netherlands	5223GZ
137	Novo Nordisk Investigational Site	Grafton		New Zealand	1023
138	Novo Nordisk Investigational Site	Skopje		North Macedonia	1000
139	Novo Nordisk Investigational Site	Bergen		Norway	5021
140	Novo Nordisk Investigational Site	Katowice		Poland	40-752
141	Novo Nordisk Investigational Site	Warszawa		Poland	04-730
142	Novo Nordisk Investigational Site	Wroclaw		Poland	50-311
143	Novo Nordisk Investigational Site	Braga		Portugal	4710-243
144	Novo Nordisk Investigational Site	Lisboa		Portugal	1169-045
145	Novo Nordisk Investigational Site	Lisboa		Portugal	1649-035
146	Novo Nordisk Investigational Site	Ponce		Puerto Rico	00717
147	Novo Nordisk Investigational Site	Timisoara	Timis	Romania	300011
148	Novo Nordisk Investigational Site	Bucharest		Romania	020614
149	Novo Nordisk Investigational Site	Bucharest		Romania	041451
150	Novo Nordisk Investigational Site	Constanta		Romania	900591
151	Novo Nordisk Investigational Site	Chelyabinsk		Russian Federation	454087
152	Novo Nordisk Investigational Site	Izhevsk		Russian Federation	426009
153	Novo Nordisk Investigational Site	Krasnoyarsk		Russian Federation	660022
154	Novo Nordisk Investigational Site	Moscow		Russian Federation	117036
155	Novo Nordisk Investigational Site	Moscow		Russian Federation	125373
156	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630048
157	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	191144
158	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194100
159	Novo Nordisk Investigational Site	Saratov		Russian Federation	410054
160	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
161	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
162	Novo Nordisk Investigational Site	Belgrade		Serbia	11070
163	Novo Nordisk Investigational Site	Nis		Serbia	18 000
164	Novo Nordisk Investigational Site	Novi Sad		Serbia	21000
165	Novo Nordisk Investigational Site	Leganés		Spain	28911
166	Novo Nordisk Investigational Site	Madrid		Spain	28009
167	Novo Nordisk Investigational Site	Madrid		Spain	28046
168	Novo Nordisk Investigational Site	Vigo		Spain	36312
169	Novo Nordisk Investigational Site	Vitoria		Spain	01009
170	Novo Nordisk Investigational Site	Göteborg		Sweden	416 85
171	Novo Nordisk Investigational Site	Huddinge		Sweden	141 57
172	Novo Nordisk Investigational Site	Uppsala		Sweden	751 85
173	Novo Nordisk Investigational Site	Tainan city		Taiwan	710
174	Novo Nordisk Investigational Site	Taoyuan		Taiwan	333
175	Novo Nordisk Investigational Site	Bangkok		Thailand	10700
176	Novo Nordisk Investigational Site	Chiang Mai		Thailand	50200
177	Novo Nordisk Investigational Site	Ankara		Turkey	06100
178	Novo Nordisk Investigational Site	Ankara		Turkey	06230
179	Novo Nordisk Investigational Site	Istanbul		Turkey	34890
180	Novo Nordisk Investigational Site	Kocaeli		Turkey	41380
181	Novo Nordisk Investigational Site	Birmingham		United Kingdom	B4 6NH
182	Novo Nordisk Investigational Site	London		United Kingdom	SE5 9RS
183	Novo Nordisk Investigational Site	Manchester		United Kingdom	M13 9WL
184	Novo Nordisk Investigational Site	Norwich		United Kingdom	NR4 7TJ
185	Novo Nordisk Investigational Site	Southampton		United Kingdom	SO16 6YD

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 3, 2017
• Statistical Analysis Plan - Jun 25, 2018

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

• Tamborlane WV, Barrientos-Pérez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01541215
• Other Study ID Numbers: NN2211-3659; 2011-002605-29; P/288/2010; U1111-1121-8743; CTRI/2013/10/004082
• First Posted: Feb 29, 2012
• Last Update Posted: Jul 2, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Liraglutide

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 84 sites in 25 countries.
Pre-assignment Detail	Eligible subjects entered an 11- to 12-week run-in period where they were to undergo a 3-4 week titration of metformin to a maximum tolerated dose of metformin (≥1000 mg and ≤2000 mg per day) followed by an 8-week maintenance period.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Period Title: Treatment Period (52 Weeks)
STARTED	66	69
Exposed	66	68
COMPLETED	56	53
NOT COMPLETED	10	16
Period Title: Treatment Period (52 Weeks)
STARTED	52	0
COMPLETED	50	0
NOT COMPLETED	2	0
Period Title: Treatment Period (52 Weeks)
STARTED	48	0
COMPLETED	48	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Liraglutide 1.8 mg	Placebo	Total
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Total of all reporting groups
Overall Participants	66	68	134
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.57 (1.73)	14.57 (1.73)	14.57 (1.72)
Sex: Female, Male (Count of Participants)
Female	41 62.1%	42 61.8%	83 61.9%
Male	25 37.9%	26 38.2%	51 38.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 24.2%	23 33.8%	39 29.1%
Not Hispanic or Latino	50 75.8%	45 66.2%	95 70.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 3%	1 1.5%	3 2.2%
Asian	10 15.2%	8 11.8%	18 13.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 13.6%	7 10.3%	16 11.9%
White	42 63.6%	45 66.2%	87 64.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 4.5%	7 10.3%	10 7.5%
Glycosylated hemoglobin (HbA1c) (percentage of HbA1c) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of HbA1c]	7.87 (1.35)	7.69 (1.34)	7.78 (1.34)

Outcome Measures

1. Primary Outcome

Title	Change in HbA1c (Glycosylated Haemoglobin)
Description	Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Least Squares Mean (Standard Error) [Percentage of HbA1c]	-0.643 (0.215)	0.415 (0.216)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Liraglutide 1.8 mg, Placebo
	Comments	Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Primary analysis: change from baseline to week 26 in HbA1c Superiority of liraglutide over placebo was to be concluded if the 95% confidence interval for the treatment difference for change from baseline in HbA1c (%) after 26 weeks of randomised treatment was entirely below 0%, implying that the two sided p-value was less than 5%.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Pattern Mixture Model
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-1.058
	Confidence Interval	(2-Sided) 95%; -1.653 to -0.464
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.304
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG)
Description	Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Least Squares Mean (Standard Error) [mmol/L]	-1.076 (0.436)	0.801 (0.449)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Liraglutide 1.8 mg, Placebo
	Comments	Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: Change from baseline in FPG after 26 weeks of treatment
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Pattern Mixture Model
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-1.878
	Confidence Interval	(2-Sided) 95%; -3.093 to -0.662
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.620
	Estimation Comments

3. Secondary Outcome

Title	Number of Subjects Having HbA1c Below 7.0%
Description	Percentage of subjects having HbA1c <7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full analysis set.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Number [Percentage of subjects]	63.7	36.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Liraglutide 1.8 mg, Placebo
	Comments	Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: HbA1c < 7.0% after 26 weeks of treatment
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	logistic regression model
	Comments
Method of Estimation	Estimation Parameter	Treatment odds ratio
	Estimated Value	5.353
	Confidence Interval	(2-Sided) 95%; 2.105 to 13.615
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
Description	Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Least Squares Mean (Standard Error) [SDS score]	-0.254 (0.039)	-0.208 (0.039)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Liraglutide 1.8 mg, Placebo
	Comments	Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 4: Change from baseline in BMI SDS after 26 weeks of treatment
Statistical Test of Hypothesis	p-Value	0.392
	Comments
	Method	Pattern Mixture Model
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.047
	Confidence Interval	(2-Sided) 95%; -0.153 to 0.060
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.055
	Estimation Comments

5. Secondary Outcome

Title	Number of Subjects Having HbA1c Below 7.0%
Description	Number of subjects achieving HbA1c <7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	52
Yes	27 40.9%	16 23.5%
No	29 43.9%	36 52.9%

6. Secondary Outcome

Title	Number of Subjects Having HbA1c Maximum 6.5%
Description	Number of subjects achieving HbA1c <=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	58
Yes	28 42.4%	19 27.9%
No	31 47%	39 57.4%

7. Secondary Outcome

Title	Number of Subjects Having HbA1c Maximum 6.5%
Description	Number of subjects achieving HbA1c <=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	52
Yes	25 37.9%	13 19.1%
No	31 47%	39 57.4%

8. Secondary Outcome

Title	Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Description	Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 26 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	58
Yes	31 47%	21 30.9%
No	28 42.4%	37 54.4%

9. Secondary Outcome

Title	Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Description	Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 52 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	52
Yes	22 33.3%	16 23.5%
No	34 51.5%	36 52.9%

10. Secondary Outcome

Title	Number of Subjects Having HbA1c Below 7.5%
Description	Number of subjects achieving HbA1c <7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	58
Yes	43 65.2%	29 42.6%
No	16 24.2%	29 42.6%

11. Secondary Outcome

Title	Number of Subjects Having HbA1c Below 7.5%
Description	Number of subjects achieving HbA1c <7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	52
Yes	36 54.5%	23 33.8%
No	20 30.3%	29 42.6%

12. Secondary Outcome

Title	Change in HbA1c
Description	Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	52
Mean (Standard Deviation) [percentage of HbA1c]	-0.732 (1.423)	0.677 (1.523)

13. Secondary Outcome

Title	Change in FPG
Description	Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Mean (Standard Deviation) [mmol/L]	-1.627 (2.717)	0.983 (3.954)

14. Secondary Outcome

Title	Change in Mean 7-point Self-measured Plasma Glucose
Description	Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: 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. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	39	46
Mean (Standard Deviation) [mmol/L]	-2.384 (2.638)	0.198 (2.056)

15. Secondary Outcome

Title	Change From Baseline in 7-point Self-measured Plasma Glucose
Description	Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: 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. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	41	39
Mean (Standard Deviation) [mmol/L]	-2.309 (2.968)	-0.748 (1.944)

16. Secondary Outcome

Title	Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Description	Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of analysed=participants with available data for specified timepoints.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	41	46
Breakfast	-1.528 (3.168)	-0.319 (3.228)
Lunch	-0.358 (3.281)	-0.658 (3.421)
Dinner	0.397 (3.790)	-0.226 (2.806)

17. Secondary Outcome

Title	Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Description	Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of analysed=participants with available data for specified timepoints.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	42	38
Breakfast	-1.802 (3.338)	0.053 (2.124)
Lunch	-0.735 (3.809)	-1.219 (3.038)
Dinner	-0.028 (3.501)	-0.195 (2.803)

18. Secondary Outcome

Title	Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Description	Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	40	46
Mean (Standard Deviation) [mmol/L]	-0.428 (2.172)	-0.362 (1.733)

19. Secondary Outcome

Title	Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Description	Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	41	39
Mean (Standard Deviation) [mmol/L]	-0.747 (2.245)	-0.397 (1.594)

20. Secondary Outcome

Title	Change From Baseline in Body Weight
Description	Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Mean (Standard Deviation) [kg]	-2.48 (5.59)	-0.87 (3.84)

21. Secondary Outcome

Title	Change From Baseline in Body Weight
Description	Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Mean (Standard Deviation) [kg]	-2.27 (8.05)	1.02 (4.64)

22. Secondary Outcome

Title	Change From Baseline in BMI Standard Deviation Score (SDS)
Description	Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Mean (Standard Deviation) [SDS score]	-0.361 (0.542)	-0.166 (0.330)

23. Secondary Outcome

Title	Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Description	Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Systolic Blood Pressure	-1.65 (10.69)	0.03 (10.05)
Diastolic Blood Pressure	-1.27 (8.39)	0.97 (7.65)

24. Secondary Outcome

Title	Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Description	Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Systolic Blood Pressure	-0.77 (11.77)	2.81 (8.48)
Diastolic Blood Pressure	0.46 (10.01)	1.83 (7.26)

25. Secondary Outcome

Title	Ratio to Baseline: Fasting Insulin
Description	Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	57
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.9 (76.4)	1.0 (77.9)

26. Secondary Outcome

Title	Ratio to Baseline: Fasting Insulin
Description	Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	54	53
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.0 (80.6)	1.1 (142.8)

27. Secondary Outcome

Title	Ratio to Baseline: Fasting Pro-insulin
Description	Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	55
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.62 (110.3)	0.88 (131.6)

28. Secondary Outcome

Title	Ratio to Baseline: Fasting Pro-insulin
Description	Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	54	49
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.62 (118.0)	0.79 (121.0)

29. Secondary Outcome

Title	Ratio to Baseline: Pro-insulin/Insulin Ratio
Description	Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	55	54
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.690 (102.4)	0.923 (197.6)

30. Secondary Outcome

Title	Ratio to Baseline: Pro-insulin/Insulin Ratio
Description	Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	53	49
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.689 (106.6)	0.770 (225.1)

31. Secondary Outcome

Title	Ratio to Baseline: Fasting Glucagon
Description	Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	57
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.98 (29.3)	1.03 (32.4)

32. Secondary Outcome

Title	Ratio to Baseline: Fasting Glucagon
Description	Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	54	52
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.01 (35.0)	1.05 (32.7)

33. Secondary Outcome

Title	Ratio to Baseline: Fasting C-peptide
Description	Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	58
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.93 (39.7)	0.84 (82.3)

34. Secondary Outcome

Title	Ratio to Baseline: Fasting C-peptide
Description	Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	54	53
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.94 (40.8)	0.83 (56.5)

35. Secondary Outcome

Title	Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Description	Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	51
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.24 (96.9)	1.01 (119.0)

36. Secondary Outcome

Title	Ratio to Baseline: HOMA-B
Description	Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	51	49
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.48 (105.0)	0.93 (166.8)

37. Secondary Outcome

Title	Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Description	Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	58	54
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.73 (80.5)	0.98 (80.8)

38. Secondary Outcome

Title	Ratio to Baseline: HOMA-IR
Description	Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	53	52
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.82 (86.4)	1.08 (140.3)

39. Secondary Outcome

Title	Ratio to Baseline: Total Cholesterol
Description	Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.975 (17.7)	1.008 (13.3)

40. Secondary Outcome

Title	Ratio to Baseline: Total Cholesterol
Description	Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	52
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.013 (21.0)	1.026 (13.5)

41. Secondary Outcome

Title	Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
Description	Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	58	57
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.998 (24.8)	0.993 (20.4)

42. Secondary Outcome

Title	Ratio to Baseline: LDL Cholesterol
Description	Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	54	48
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.042 (46.3)	1.035 (21.5)

43. Secondary Outcome

Title	Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
Description	Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	58
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.890 (51.6)	1.035 (35.3)

44. Secondary Outcome

Title	Ratio to Baseline: VLDL Cholesterol
Description	Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	51
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.983 (48.4)	1.003 (45.5)

45. Secondary Outcome

Title	Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
Description	Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	58
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.997 (18.7)	0.981 (16.3)

46. Secondary Outcome

Title	Ratio to Baseline: HDL Cholesterol
Description	Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	51
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.028 (16.0)	1.000 (18.8)

47. Secondary Outcome

Title	Ratio to Baseline: Triglycerides
Description	Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.894 (50.6)	1.038 (36.0)

48. Secondary Outcome

Title	Ratio to Baseline: Triglycerides
Description	Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.964 (50.5)	1.036 (48.4)

49. Secondary Outcome

Title	Ratio to Baseline: Free Fatty Acids
Description	Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	59	58
Geometric Mean (Geometric Coefficient of Variation) [ratio]	1.023 (67.4)	0.985 (47.5)

50. Secondary Outcome

Title	Ratio to Baseline: Free Fatty Acids
Description	Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Full analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	54	51
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.928 (58.2)	0.868 (54.8)

51. Secondary Outcome

Title	Change From Baseline in Pulse
Description	Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Safety analysis set - included all subjects receiving at least one dose of liraglutide/placebo (134 subjects). Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Mean (Standard Deviation) [beats/minute]	1.40 (10.89)	0.33 (7.69)

52. Secondary Outcome

Title	Change From Baseline in Pulse
Description	Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Mean (Standard Deviation) [beats/minute]	-0.05 (10.39)	-0.28 (7.88)

53. Secondary Outcome

Title	Change From Baseline in Height SDS
Description	Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Mean (Standard Deviation) [SDS score]	-0.100 (0.133)	-0.042 (0.210)

54. Secondary Outcome

Title	Change From Baseline in Height SDS
Description	Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Mean (Standard Deviation) [SDS score]	-0.192 (0.223)	-0.134 (0.293)

55. Secondary Outcome

Title	Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
Description	Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	31	26
Mean (Standard Deviation) [years]	1.197 (0.899)	1.088 (0.889)

56. Secondary Outcome

Title	Pubertal Assessment/Progression (Tanner Staging)
Description	Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.
Time Frame	Week 0, week 26, week 52

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Stage I	1 1.5%	0 0%
Stage II	2 3%	0 0%
Stage III	4 6.1%	10 14.7%
Stage IV	8 12.1%	9 13.2%
Stage V	26 39.4%	23 33.8%
Stage I	0 0%	0 0%
Stage II	1 1.5%	0 0%
Stage III	2 3%	4 5.9%
Stage IV	5 7.6%	10 14.7%
Stage V	29 43.9%	22 32.4%
Stage I	0 0%	0 0%
Stage II	0 0%	0 0%
Stage III	1 1.5%	2 2.9%
Stage IV	5 7.6%	9 13.2%
Stage V	27 40.9%	22 32.4%
Stage I	2 3%	0 0%
Stage II	1 1.5%	3 4.4%
Stage III	2 3%	6 8.8%
Stage IV	9 13.6%	11 16.2%
Stage V	11 16.7%	6 8.8%
Stage I	2 3%	0 0%
Stage II	1 1.5%	1 1.5%
Stage III	2 3%	4 5.9%
Stage IV	7 10.6%	8 11.8%
Stage V	13 19.7%	10 14.7%
Stage I	1 1.5%	0 0%
Stage II	2 3%	0 0%
Stage III	0 0%	2 2.9%
Stage IV	7 10.6%	6 8.8%
Stage V	15 22.7%	13 19.1%
Stage I	3 4.5%	3 4.4%
Stage II	3 4.5%	0 0%
Stage III	8 12.1%	10 14.7%
Stage IV	14 21.2%	25 36.8%
Stage V	38 57.6%	29 42.6%
Stage I	3 4.5%	0 0%
Stage II	0 0%	2 2.9%
Stage III	5 7.6%	4 5.9%
Stage IV	11 16.7%	18 26.5%
Stage V	43 65.2%	34 50%
Stage I	1 1.5%	0 0%
Stage II	1 1.5%	0 0%
Stage III	4 6.1%	2 2.9%
Stage IV	8 12.1%	17 25%
Stage V	43 65.2%	34 50%

57. Secondary Outcome

Title	Growth (Height Velocity)
Description	Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Mean (Standard Deviation) [cm/year]	1.633 (2.016)	2.486 (2.834)

58. Secondary Outcome

Title	Growth (Height Velocity)
Description	Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	56	53
Mean (Standard Deviation) [cm/year]	1.345 (1.730)	1.817 (2.043)

59. Secondary Outcome

Title	Height Velocity SDS
Description	Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	60	58
Mean (Standard Deviation) [SDS score]	-1.24 (1.695)	-0.557 (2.058)

60. Secondary Outcome

Title	Height Velocity SDS
Description	Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

Safety analysis set. Number of participants analysed=participants with available data.

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	52	48
Mean (Standard Deviation) [SDS score]	-0.887 (1.460)	-0.551 (1.711)

61. Secondary Outcome

Title	Number of Hypoglycaemic Episodes
Description	Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.
Time Frame	0-26 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Number [hypoglycaemic episodes]	92	43

62. Secondary Outcome

Title	Number of Hypoglycaemic Episodes
Description	Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.
Time Frame	0-52 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Number [hypoglycaemic episodes]	160	63

63. Secondary Outcome

Title	Number of Adverse Events (Week 0-26)
Description	Total number of adverse events during 26 weeks.
Time Frame	0-26 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Number [events]	310	230

64. Secondary Outcome

Title	Number of Adverse Events (Week 0-52)
Description	Total number of adverse events during entire treatment period.
Time Frame	0-52 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Number [events]	426	321

65. Secondary Outcome

Title	Number of Serious Adverse Events (Week 0-26)
Description	Total number of serious adverse events during 26 weeks.
Time Frame	0-26 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Number [events]	7	4

66. Secondary Outcome

Title	Number of Serious Adverse Events (Week 0-52)
Description	Total number of serious adverse events during entire treatment period.
Time Frame	0-52 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Liraglutide 1.8 mg	Placebo
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Measure Participants	66	68
Number [events]	10	5

67. Secondary Outcome

Title	Number of Adverse Events (Week 53-104)
Description	This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).
Time Frame	Week 53-104

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
Measure Participants	52
Number [events]	30

68. Secondary Outcome

Title	Number of Serious Adverse Events (Week 53-104)
Description	This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).
Time Frame	Weeks 53-104

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
Measure Participants	52
Number [events]	7

69. Secondary Outcome

Title	Growth (Height Velocity)- Week 104
Description	Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 0, week 104

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
Measure Participants	50
Mean (Standard Deviation) [cm/year]	1.149 (1.776)

70. Secondary Outcome

Title	Height Velocity SDS- Week 104
Description	The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 0, week 104

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
Measure Participants	41
Mean (Standard Deviation) [SDS score]	-0.523 (1.466)

71. Secondary Outcome

Title	Change From Week 52 in Height SDS- Week 104
Description	Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 52, week 104

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
Measure Participants	49
Mean (Standard Deviation) [SDS score]	-0.133 (0.338)

72. Secondary Outcome

Title	Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
Description	Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 52, week 104

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Number analyzed= subjects with available data.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
Measure Participants	52
Stage I	0 0%
Stage II	0 0%
Stage III	1 1.5%
Stage IV	5 7.6%
Stage V	21 31.8%
Stage I	0 0%
Stage II	0 0%
Stage III	0 0%
Stage IV	5 7.6%
Stage V	11 16.7%
Stage I	1 1.5%
Stage II	2 3%
Stage III	0 0%
Stage IV	7 10.6%
Stage V	14 21.2%
Stage I	0 0%
Stage II	1 1.5%
Stage III	0 0%
Stage IV	5 7.6%
Stage V	8 12.1%
Stage I	0 0%
Stage II	0 0%
Stage III	2 3%
Stage IV	2 3%
Stage V	22 33.3%
Stage I	0 0%
Stage II	0 0%
Stage III	1 1.5%
Stage IV	2 3%
Stage V	13 19.7%
Stage I	1 1.5%
Stage II	1 1.5%
Stage III	2 3%
Stage IV	6 9.1%
Stage V	14 21.2%
Stage I	0 0%
Stage II	1 1.5%
Stage III	0 0%
Stage IV	4 6.1%
Stage V	9 13.6%

73. Secondary Outcome

Title	Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
Description	Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 52, week 104

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
Measure Participants	13
Mean (Standard Deviation) [Years]	1.231 (0.992)

74. Secondary Outcome

Title	Number of Adverse Events (Week 53-156)
Description	This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).
Time Frame	Week 53-156

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1 and 2
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
Measure Participants	52
Number [events]	47

75. Secondary Outcome

Title	Number of Serious Adverse Events (Week 53-156)
Description	This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).
Time Frame	Weeks 53-156

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1 and 2
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
Measure Participants	52
Number [events]	9

76. Secondary Outcome

Title	Growth (Height Velocity)- Week 156
Description	Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 0, week 156

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1 and 2
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
Measure Participants	45
Mean (Standard Deviation) [cm/year]	1.100 (1.504)

77. Secondary Outcome

Title	Height Velocity SDS- Week 156
Description	The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 0, week 156

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1 and 2
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
Measure Participants	27
Mean (Standard Deviation) [SDS score]	0.142 (1.156)

78. Secondary Outcome

Title	Change From Week 52 in Height SDS- Week 156
Description	Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 52, week 156

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1 and 2
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
Measure Participants	36
Mean (Standard Deviation) [SDS score]	-0.224 (0.446)

79. Secondary Outcome

Title	Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
Description	Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 52, week 156

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Number analyzed= subjects with available data.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1 and 2
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
Measure Participants	52
Stage I	0 0%
Stage II	0 0%
Stage III	1 1.5%
Stage IV	5 7.6%
Stage V	21 31.8%
Stage I	0 0%
Stage II	0 0%
Stage III	0 0%
Stage IV	3 4.5%
Stage V	11 16.7%
Stage I	1 1.5%
Stage II	2 3%
Stage III	0 0%
Stage IV	7 10.6%
Stage V	14 21.2%
Stage I	0 0%
Stage II	0 0%
Stage III	1 1.5%
Stage IV	3 4.5%
Stage V	9 13.6%
Stage I	0 0%
Stage II	0 0%
Stage III	2 3%
Stage IV	2 3%
Stage V	22 33.3%
Stage I	0 0%
Stage II	0 0%
Stage III	0 0%
Stage IV	2 3%
Stage V	11 16.7%
Stage I	1 1.5%
Stage II	1 1.5%
Stage III	2 3%
Stage IV	6 9.1%
Stage V	14 21.2%
Stage I	0 0%
Stage II	0 0%
Stage III	1 1.5%
Stage IV	3 4.5%
Stage V	10 15.2%

80. Secondary Outcome

Title	Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
Description	Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time Frame	Week 52, week 156

Outcome Measure Data

Analysis Population Description

Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

Arm/Group Title	Liraglutide 1.8 mg: Follow-up 1 and 2
Arm/Group Description	Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
Measure Participants	9
Mean (Standard Deviation) [Years]	1.778 (1.277)

Adverse Events

Time Frame	Week 0 - 156. All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration.
Adverse Event Reporting Description	Adverse events were reported per reporting group for treatment period and follow up period. Results are based on SAS which included subjects: who received at least one dose of liraglutide or placebo for "Liraglutide 1.8 mg- Treatment period" and "Placebo" and who received liraglutide for more than 3 months during treatment period (week 0-52) and provided follow-up data anytime during weeks 53-104 for "Liraglutide 1.8 mg: Follow-up 1" and weeks 105-156 for "Liraglutide 1.8 mg: Follow-up 2".
Arm/Group Title	Liraglutide 1.8 mg		Placebo		Liraglutide 1.8 mg: Follow-up 1		Liraglutide 1.8 mg: Follow-up 2
Arm/Group Description	After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).		After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.		Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.		Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 156.
All Cause Mortality
	Liraglutide 1.8 mg		Placebo		Liraglutide 1.8 mg: Follow-up 1		Liraglutide 1.8 mg: Follow-up 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/68 (0%)		0/52 (0%)		0/48 (0%)
Serious Adverse Events
	Liraglutide 1.8 mg		Placebo		Liraglutide 1.8 mg: Follow-up 1		Liraglutide 1.8 mg: Follow-up 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/66 (13.6%)		4/68 (5.9%)		7/52 (13.5%)		2/48 (4.2%)
Ear and labyrinth disorders
Vertigo	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	0/48 (0%)	0
Gastrointestinal disorders
Abdominal pain	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	1/48 (2.1%)	1
Diarrhoea	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	0/48 (0%)	0
Constipation	0/66 (0%)	0	0/68 (0%)	0	1/52 (1.9%)	1	0/48 (0%)	0
Malocclusion	0/66 (0%)	0	0/68 (0%)	0	0/52 (0%)	0	1/48 (2.1%)	1
Infections and infestations
Abscess neck	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	0/48 (0%)	0
Appendicitis perforated	0/66 (0%)	0	1/68 (1.5%)	1	0/52 (0%)	0	0/48 (0%)	0
Pneumonia	0/66 (0%)	0	1/68 (1.5%)	1	0/52 (0%)	0	0/48 (0%)	0
Viral infection	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	0/48 (0%)	0
Subcutaneous abscess	0/66 (0%)	0	0/68 (0%)	0	1/52 (1.9%)	1	0/48 (0%)	0
Appendicitis	0/66 (0%)	0	0/68 (0%)	0	0/52 (0%)	0	1/48 (2.1%)	1
Investigations
Glycosylated haemoglobin increased	1/66 (1.5%)	1	1/68 (1.5%)	1	0/52 (0%)	0	0/48 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/66 (0%)	0	1/68 (1.5%)	1	0/52 (0%)	0	0/48 (0%)	0
Hyperglycaemia	1/66 (1.5%)	1	1/68 (1.5%)	1	2/52 (3.8%)	2	0/48 (0%)	0
Musculoskeletal and connective tissue disorders
Scoliosis	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	0/48 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	0/48 (0%)	0
Nervous system disorders
Nervous system disorder	1/66 (1.5%)	1	0/68 (0%)	0	0/52 (0%)	0	0/48 (0%)	0
Psychiatric disorders
Depressive symptom	0/66 (0%)	0	0/68 (0%)	0	1/52 (1.9%)	1	0/48 (0%)	0
Surgical and medical procedures
Fasciotomy	0/66 (0%)	0	0/68 (0%)	0	1/52 (1.9%)	1	0/48 (0%)	0
Metabolic surgery	0/66 (0%)	0	0/68 (0%)	0	1/52 (1.9%)	1	0/48 (0%)	0
Other (Not Including Serious) Adverse Events
	Liraglutide 1.8 mg		Placebo		Liraglutide 1.8 mg: Follow-up 1		Liraglutide 1.8 mg: Follow-up 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/66 (68.2%)		49/68 (72.1%)		7/52 (13.5%)		1/48 (2.1%)
Gastrointestinal disorders
Abdominal pain	11/66 (16.7%)	22	5/68 (7.4%)	6	1/52 (1.9%)	1	0/48 (0%)	0
Abdominal pain upper	2/66 (3%)	3	8/68 (11.8%)	9	0/52 (0%)	0	0/48 (0%)	0
Constipation	4/66 (6.1%)	4	1/68 (1.5%)	1	1/52 (1.9%)	1	0/48 (0%)	0
Diarrhoea	15/66 (22.7%)	21	11/68 (16.2%)	13	0/52 (0%)	0	0/48 (0%)	0
Dyspepsia	5/66 (7.6%)	6	1/68 (1.5%)	1	1/52 (1.9%)	1	0/48 (0%)	0
Nausea	19/66 (28.8%)	25	9/68 (13.2%)	12	1/52 (1.9%)	1	0/48 (0%)	0
Vomiting	17/66 (25.8%)	46	6/68 (8.8%)	8	2/52 (3.8%)	2	0/48 (0%)	0
General disorders
Pyrexia	4/66 (6.1%)	5	5/68 (7.4%)	5	0/52 (0%)	0	0/48 (0%)	0
Infections and infestations
Gastroenteritis	7/66 (10.6%)	8	2/68 (2.9%)	2	0/52 (0%)	0	0/48 (0%)	0
Influenza	4/66 (6.1%)	6	6/68 (8.8%)	9	0/52 (0%)	0	0/48 (0%)	0
Nasopharyngitis	11/66 (16.7%)	16	19/68 (27.9%)	28	2/52 (3.8%)	2	0/48 (0%)	0
Pharyngitis	4/66 (6.1%)	5	4/68 (5.9%)	6	0/52 (0%)	0	1/48 (2.1%)	1
Upper respiratory tract infection	6/66 (9.1%)	10	5/68 (7.4%)	8	0/52 (0%)	0	0/48 (0%)	0
Investigations
Alanine aminotransferase increased	0/66 (0%)	0	4/68 (5.9%)	5	0/52 (0%)	0	0/48 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	4/66 (6.1%)	4	3/68 (4.4%)	3	0/52 (0%)	0	0/48 (0%)	0
Hyperglycaemia	4/66 (6.1%)	4	4/68 (5.9%)	4	1/52 (1.9%)	1	1/48 (2.1%)	1
Nervous system disorders
Dizziness	8/66 (12.1%)	10	2/68 (2.9%)	4	0/52 (0%)	0	0/48 (0%)	0
Headache	14/66 (21.2%)	27	13/68 (19.1%)	39	0/52 (0%)	0	0/48 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	3/66 (4.5%)	10	6/68 (8.8%)	11	0/52 (0%)	0	0/48 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	4/66 (6.1%)	7	4/68 (5.9%)	5	0/52 (0%)	0	0/48 (0%)	0
Oropharyngeal pain	4/66 (6.1%)	6	6/68 (8.8%)	10	0/52 (0%)	0	0/48 (0%)	0
Rhinorrhoea	1/66 (1.5%)	2	4/68 (5.9%)	4	0/52 (0%)	0	0/48 (0%)	0
Skin and subcutaneous tissue disorders
Rash	4/66 (6.1%)	5	1/68 (1.5%)	1	0/52 (0%)	0	0/48 (0%)	0

Limitations/Caveats

[Not Specified]

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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.