onset®8: Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02500706
• Collaborator: (none)
• Enrollment: 1,108
• Locations: 152
• Arms: 3
• Actual Duration (Months): 15.4
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1	Drug: Faster-acting insulin aspart; Drug: insulin aspart; Drug: insulin degludec	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
• Actual Study Start Date: May 4, 2016
• Actual Primary Completion Date: Jul 17, 2017
• Actual Study Completion Date: Aug 16, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mealtime faster-acting insulin aspart and insulin degludec	Drug: Faster-acting insulin aspart; Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.; Drug: insulin degludec; Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted
Active Comparator: Mealtime NovoRapid® and insulin degludec	Drug: insulin aspart; Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.; Drug: insulin degludec; Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted
Experimental: Postmeal faster-acting insulin aspart and insulin degludec	Drug: Faster-acting insulin aspart; Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.; Drug: insulin degludec; Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in HbA1c 26 Weeks After Randomisation [Week 0, week 26]

   Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.

Secondary Outcome Measures

1. Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) [Week 0, week 26]

   The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

2. Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation [Week 0, week 26]

   The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

3. Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation [Week 0, week 26]

   The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

4. Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation [26 weeks after randomisation]

   The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

5. Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation [26 weeks after randomisation]

   The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

6. Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation [26 weeks after randomisation]

   The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.

7. Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation [Week 0, week 26]

   Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

8. Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation [Week 0, week 26]

   Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

9. Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile [Week 0, week 26]

   The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

10. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) [Week 0, week 26]

    The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

11. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) [Week 0, week 26]

    The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

12. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile [Week 0, week 26]

    The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

13. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements [Week 0, week 26]

    The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).

14. Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L [26 weeks after randomisation]

    Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.

15. Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia [26 weeks after randomisation]

    Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.

16. Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia [26 weeks after randomisation]

    The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.

17. Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) [Week 0, week 26]

    Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).

18. Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) [Week 0, week 26]

    The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

19. Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation [Week 0 to week 26 (+7 days)]

    A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

20. Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation [Week 0 to week 26 (+7 days)]

    A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

21. Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall [Week 0 to week 26 (+1 day)]

    ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia. NN Classification: Severe:same as per ADA classification Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.

22. Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) [Week 0 to week 26 (+1 day)]

    ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.

23. Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal [Week 0 to week 26 (+1 day)]

    ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.

24. Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) [Week 0, week 26]

    The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.

25. Change From Baseline in Blood Pressure 26 Weeks After Randomisation [Week 0, week 26]

    Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

26. Change From Baseline in Pulse 26 Weeks After Randomisation [Week 0, week 26]

    Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

27. Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation [Week 0, week 26]

    The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.

28. Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation [Week 0, week 26]

    The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.

29. Change From Baseline in Erythrocytes 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

30. Change From Baseline in Haematocrit 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

31. Change From Baseline in Haemoglobin 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

32. Change From Baseline in Leukocytes 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

33. Change From Baseline in Thrombocytes 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

34. Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

35. Change From Baseline in Albumin 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

36. Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

37. Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

38. Change From Baseline in Total Bilirubin 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

39. Change From Baseline in Potassium 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

40. Change From Baseline in Creatinine 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

41. Change From Baseline in Total Protein 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

42. Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation [Week 0, week 26]

    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

43. Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation [Week 0, week 26]

    Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

44. Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation [Week 0, week 26]

    Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

45. Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation [Week 0, week 26]

    Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

46. Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation [Week 0, week 26]

    Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).

47. Change From Baseline in Body Weight 26 Weeks After Randomisation [Week 0, week 26]

    The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

48. Change From Baseline in Body Mass Index 26 Weeks After Randomisation [Week 0, week 26]

    The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Tucson	Arizona	United States	85714
2	Novo Nordisk Investigational Site	Concord	California	United States	94520
3	Novo Nordisk Investigational Site	Encino	California	United States	91436
4	Novo Nordisk Investigational Site	Escondido	California	United States	92025
5	Novo Nordisk Investigational Site	Fresno	California	United States	93720
6	Novo Nordisk Investigational Site	Fullerton	California	United States	92835
7	Novo Nordisk Investigational Site	Huntington Beach	California	United States	92648
8	Novo Nordisk Investigational Site	Monterey	California	United States	93940
9	Novo Nordisk Investigational Site	Newport Beach	California	United States	92663
10	Novo Nordisk Investigational Site	Santa Barbara	California	United States	93105
11	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
12	Novo Nordisk Investigational Site	Denver	Colorado	United States	80209
13	Novo Nordisk Investigational Site	Golden	Colorado	United States	80401
14	Novo Nordisk Investigational Site	Palm Harbor	Florida	United States	34684
15	Novo Nordisk Investigational Site	Tampa	Florida	United States	33607
16	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
17	Novo Nordisk Investigational Site	Idaho Falls	Idaho	United States	83404-7596
18	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
19	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
20	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40213
21	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21204
22	Novo Nordisk Investigational Site	Rockville	Maryland	United States	20852
23	Novo Nordisk Investigational Site	Flint	Michigan	United States	48503-5904
24	Novo Nordisk Investigational Site	Kalamazoo	Michigan	United States	49048
25	Novo Nordisk Investigational Site	Minneapolis	Minnesota	United States	55416
26	Novo Nordisk Investigational Site	Jefferson City	Missouri	United States	65109
27	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89148
28	Novo Nordisk Investigational Site	Nashua	New Hampshire	United States	03063
29	Novo Nordisk Investigational Site	Hamilton	New Jersey	United States	08690
30	Novo Nordisk Investigational Site	Lawrenceville	New Jersey	United States	08648
31	Novo Nordisk Investigational Site	Albuquerque	New Mexico	United States	87109-2134
32	Novo Nordisk Investigational Site	Albany	New York	United States	12206
33	Novo Nordisk Investigational Site	Rochester	New York	United States	14607
34	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27517
35	Novo Nordisk Investigational Site	Greenville	North Carolina	United States	27834
36	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
37	Novo Nordisk Investigational Site	Bend	Oregon	United States	97702
38	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19114
39	Novo Nordisk Investigational Site	Chattanooga	Tennessee	United States	37411
40	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
41	Novo Nordisk Investigational Site	Austin	Texas	United States	78731
42	Novo Nordisk Investigational Site	Austin	Texas	United States	78749
43	Novo Nordisk Investigational Site	Beaumont	Texas	United States	77701
44	Novo Nordisk Investigational Site	Dallas	Texas	United States	75218
45	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
46	Novo Nordisk Investigational Site	Dallas	Texas	United States	75231
47	Novo Nordisk Investigational Site	Dallas	Texas	United States	75246
48	Novo Nordisk Investigational Site	Mesquite	Texas	United States	75149
49	Novo Nordisk Investigational Site	Round Rock	Texas	United States	78681
50	Novo Nordisk Investigational Site	Murray	Utah	United States	84123
51	Novo Nordisk Investigational Site	Ogden	Utah	United States	84405
52	Novo Nordisk Investigational Site	Salt Lake City	Utah	United States	84102
53	Novo Nordisk Investigational Site	Salt Lake City	Utah	United States	84107
54	Novo Nordisk Investigational Site	Federal Way	Washington	United States	98003
55	Novo Nordisk Investigational Site	Renton	Washington	United States	98057
56	Novo Nordisk Investigational Site	Spokane	Washington	United States	99201
57	Novo Nordisk Investigational Site	Tacoma	Washington	United States	98405
58	Novo Nordisk Investigational Site	Graz		Austria	8036
59	Novo Nordisk Investigational Site	Salzburg		Austria	5020
60	Novo Nordisk Investigational Site	Wien		Austria	1030
61	Novo Nordisk Investigational Site	Wien		Austria	1130
62	Novo Nordisk Investigational Site	Dimitrovgrad		Bulgaria	6400
63	Novo Nordisk Investigational Site	Pleven		Bulgaria	5800
64	Novo Nordisk Investigational Site	Plovdiv		Bulgaria	4002
65	Novo Nordisk Investigational Site	Ruse		Bulgaria	7000
66	Novo Nordisk Investigational Site	Sofia		Bulgaria	1431
67	Novo Nordisk Investigational Site	Sofia		Bulgaria	1606
68	Novo Nordisk Investigational Site	Varna		Bulgaria	9010
69	Novo Nordisk Investigational Site	Calgary	Alberta	Canada	T2H 2G4
70	Novo Nordisk Investigational Site	Halifax	Nova Scotia	Canada	B3H 2Y9
71	Novo Nordisk Investigational Site	Concord	Ontario	Canada	L4K 4M2
72	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H2W 1R7
73	Novo Nordisk Investigational Site	Quebec		Canada	G1V 4G2
74	Novo Nordisk Investigational Site	Quebec		Canada	G1V 4G5
75	Novo Nordisk Investigational Site	Berlin		Germany	12163
76	Novo Nordisk Investigational Site	Berlin		Germany	13597
77	Novo Nordisk Investigational Site	Dresden		Germany	01219
78	Novo Nordisk Investigational Site	Falkensee		Germany	14612
79	Novo Nordisk Investigational Site	Lingen		Germany	49808
80	Novo Nordisk Investigational Site	Münster		Germany	48145
81	Novo Nordisk Investigational Site	Neuwied		Germany	56564
82	Novo Nordisk Investigational Site	Schweinfurt		Germany	97421
83	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh	India	500072
84	Novo Nordisk Investigational Site	Visakhapatnam	Andhra Pradesh	India	530002
85	Novo Nordisk Investigational Site	Ahmedabad	Gujarat	India	380006
86	Novo Nordisk Investigational Site	Ahmedabad	Gujarat	India	380052
87	Novo Nordisk Investigational Site	Rohtak	Haryana	India	124001
88	Novo Nordisk Investigational Site	Kozhikode	Kerala	India	673017
89	Novo Nordisk Investigational Site	Indore	Madhya Pradesh	India	452008
90	Novo Nordisk Investigational Site	Indore	Madhya Pradesh	India	452010
91	Novo Nordisk Investigational Site	Pune	Maharashtra	India	411001
92	Novo Nordisk Investigational Site	Bhubaneswar	Orissa	India	751019
93	Novo Nordisk Investigational Site	Chennai	Tamil Nadu	India	600 013
94	Novo Nordisk Investigational Site	Chennai	Tamil Nadu	India	600086
95	Novo Nordisk Investigational Site	Vellore	Tamil Nadu	India	632004
96	Novo Nordisk Investigational Site	Chandigarh		India	160012
97	Novo Nordisk Investigational Site	New Dehli		India	110029
98	Novo Nordisk Investigational Site	New Delhi		India	110001
99	Novo Nordisk Investigational Site	Pune		India	411011
100	Novo Nordisk Investigational Site	Haifa		Israel	31096
101	Novo Nordisk Investigational Site	Holon		Israel	58100
102	Novo Nordisk Investigational Site	Jerusalem		Israel	91120
103	Novo Nordisk Investigational Site	Jerusalem		Israel	93106
104	Novo Nordisk Investigational Site	Petah Tikva		Israel	49202
105	Novo Nordisk Investigational Site	Rishon Le Zion		Israel	75650
106	Novo Nordisk Investigational Site	Ancona		Italy	60100
107	Novo Nordisk Investigational Site	Bergamo		Italy	24127
108	Novo Nordisk Investigational Site	Catanzaro		Italy	88100
109	Novo Nordisk Investigational Site	Milano		Italy	20132
110	Novo Nordisk Investigational Site	Rome		Italy	00168
111	Novo Nordisk Investigational Site	Sesto San Giovanni (MI)		Italy	20099
112	Novo Nordisk Investigational Site	Amagasaki-shi, Hyogo		Japan	661-0002
113	Novo Nordisk Investigational Site	Chuo-ku, Tokyo		Japan	103-0002
114	Novo Nordisk Investigational Site	Ebina-shi, Kanagawa		Japan	243-0432
115	Novo Nordisk Investigational Site	Fukuoka		Japan	830 8522
116	Novo Nordisk Investigational Site	Fukushima		Japan	963-8851
117	Novo Nordisk Investigational Site	Hokkaido		Japan	060-0062
118	Novo Nordisk Investigational Site	Hokkaido		Japan	062-0007
119	Novo Nordisk Investigational Site	Ibaraki		Japan	305-0812
120	Novo Nordisk Investigational Site	Ibaraki		Japan	311-0113
121	Novo Nordisk Investigational Site	Izumisano-shi		Japan	598 0048
122	Novo Nordisk Investigational Site	Kanagawa		Japan	235-0045
123	Novo Nordisk Investigational Site	Kobe-shi, Hyogo		Japan	657-0846
124	Novo Nordisk Investigational Site	Kumamoto		Japan	862-0976
125	Novo Nordisk Investigational Site	Matsumoto-shi, Nagano		Japan	390-8621
126	Novo Nordisk Investigational Site	Mito-shi, Ibaraki		Japan	311-4153
127	Novo Nordisk Investigational Site	Miyazaki		Japan	880-0034
128	Novo Nordisk Investigational Site	Oita-shi		Japan	870 0039
129	Novo Nordisk Investigational Site	Osaka-shi, Osaka		Japan	545 8586
130	Novo Nordisk Investigational Site	Osaka		Japan	569-1045
131	Novo Nordisk Investigational Site	Ota-ku, Tokyo		Japan	1430015
132	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido		Japan	060-0001
133	Novo Nordisk Investigational Site	Tokyo		Japan	105-8471
134	Novo Nordisk Investigational Site	Tokyo		Japan	113-8431
135	Novo Nordisk Investigational Site	Tokyo		Japan	162 8666
136	Novo Nordisk Investigational Site	Ponce		Puerto Rico	00716
137	Novo Nordisk Investigational Site	Barnaul		Russian Federation	656045
138	Novo Nordisk Investigational Site	Kazan		Russian Federation	420061
139	Novo Nordisk Investigational Site	Moscow		Russian Federation	119435
140	Novo Nordisk Investigational Site	Moscow		Russian Federation	123423
141	Novo Nordisk Investigational Site	Moscow		Russian Federation	125367
142	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630047
143	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630117
144	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194358
145	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	195213
146	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	199226
147	Novo Nordisk Investigational Site	Saratov		Russian Federation	410053
148	Novo Nordisk Investigational Site	Tumen		Russian Federation	625023
149	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
150	Novo Nordisk Investigational Site	Taipei		Taiwan	104
151	Novo Nordisk Investigational Site	Taipei		Taiwan	112
152	Novo Nordisk Investigational Site	Taoyuan		Taiwan	333

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 13, 2018
• Statistical Analysis Plan - Mar 13, 2018

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

• Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02500706
• Other Study ID Numbers: NN1218-4131; 2015-001047-36; U1111-1167-9495
• First Posted: Jul 16, 2015
• Last Update Posted: Jun 12, 2019
• Last Verified: May 1, 2019

• 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 1; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 146 sites in 12 countries(number of sites indicates those that both screened and randomised subjects, unless otherwise noted)-Austria(4);Bulgaria(8); Canada(6); Germany(7); India(16); Israel(6); Italy(4); Japan(24); Russian Federation(10); Serbia(3); Taiwan(3); United States(55 sites screened/52 sites randomised subjects)
Pre-assignment Detail	Eligible subjects were enrolled in a 8-week run-in period (1108 subjects) where subjects were switched from previous insulin treatment to insulin degludec once daily,and NovoRapid®/NovoLog® as mealtime bolus insulin. The basal insulin treatment was optimised using treat-to-target approach. 83 subjects were run-in failures and 1025 were randomised.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Period Title: Overall Study
STARTED	342	341	342
Exposed	342	341	342
COMPLETED	338	334	335
NOT COMPLETED	4	7	7

Baseline Characteristics

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)	Total
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Total of all reporting groups
Overall Participants	342	341	342	1025
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.48 (14.42)	41.02 (14.59)	40.77 (14.22)	41.09 (14.40)
Sex: Female, Male (Count of Participants)
Female	158 46.2%	155 45.5%	163 47.7%	476 46.4%
Male	184 53.8%	186 54.5%	179 52.3%	549 53.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 3.8%	8 2.3%	12 3.5%	33 3.2%
Not Hispanic or Latino	329 96.2%	333 97.7%	330 96.5%	992 96.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	0 0%	1 0.3%	2 0.2%
Asian	116 33.9%	131 38.4%	137 40.1%	384 37.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	6 1.8%	4 1.2%	6 1.8%	16 1.6%
White	219 64%	206 60.4%	198 57.9%	623 60.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Glycosylated hemoglobin (HbA1c) (percentage of HbA1c) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of HbA1c]	7.46 (0.68)	7.40 (0.60)	7.41 (0.79)	7.42 (0.70)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in HbA1c 26 Weeks After Randomisation
Description	Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	341
Mean (Standard Deviation) [percentage of HbA1c]	-0.12 (0.64)	0.005 (0.64)	-0.09 (0.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Meal), NovoRapid (Meal)
	Comments	The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value from the 2-sided test for treatment difference evaluated at the 5% level
	Method	ANOVA model after multiple imputation
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.11 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Post), NovoRapid (Meal)
	Comments	The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®. Non-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value from the 2-sided test for treatment difference evaluated at the 5% level.
	Method	ANOVA model after multiple imputation
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 95%; 0.004 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Meal), NovoRapid (Meal)
	Comments	The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®. Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points.
Statistical Test of Hypothesis	p-Value	0.633
	Comments	p-value from the 2-sided test for treatment difference evaluated at the 5% level
	Method	ANOVA model after multiple imputation
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.11 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)
Description	The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	332	332	326
Mean (Standard Deviation) [mmol/L]	-1.13 (4.04)	1.04 (3.53)	-0.15 (3.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Meal), NovoRapid (Meal)
	Comments	Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog. Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value from the 2-sided test for treatment difference evaluated at the 5% level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.90
	Confidence Interval	(2-Sided) 95%; -1.36 to -0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation
Description	The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	341	336	338
Mean (Standard Deviation) [ug/mL]	0.22 (2.23)	-0.15 (2.10)	0.22 (2.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Meal), NovoRapid (Meal)
	Comments	Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®. Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0.
Statistical Test of Hypothesis	p-Value	0.924
	Comments	p-values are from the 2-sided test for treatment difference evaluated at the 5% level.
	Method	ANOVA model after multiple imputation
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.31 to 0.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation
Description	The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	339	338	336
Mean (Standard Deviation) [mmol/L]	0.17 (2.94)	0.44 (3.29)	0.64 (3.35)

5. Secondary Outcome

Title	Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation
Description	The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.
Time Frame	26 weeks after randomisation

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Yes	28.7	28.2	32.7
No	71.3	71.8	67.3

6. Secondary Outcome

Title	Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation
Description	The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.
Time Frame	26 weeks after randomisation

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Yes	25.7	26.4	30.4
No	74.3	73.6	69.6

7. Secondary Outcome

Title	Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation
Description	The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.
Time Frame	26 weeks after randomisation

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Yes	16.4	17.9	19.3
No	83.6	82.1	80.7

8. Secondary Outcome

Title	Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation
Description	Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Change in PPG at 30 min	-0.47 (3.58)	1.31 (3.52)	0.21 (3.78)
Change in PPG at 1 hour	-1.05 (4.56)	1.39 (4.44)	0.20 (4.52)
Change in PPG at 2 hours	-0.41 (5.17)	0.80 (5.38)	0.33 (5.51)
Change in PPG at 3 hours	-0.12 (5.20)	0.93 (5.06)	0.51 (5.33)
Change in PPG at 4 hours	0.005 (4.64)	0.83 (4.59)	0.53 (4.60)

9. Secondary Outcome

Title	Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation
Description	Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Change in PPG increment at 30 min	-0.55 (2.55)	0.94 (2.47)	-0.14 (2.63)
Change in PPG increment at 1 hour	-1.13 (4.04)	1.04 (3.53)	-0.15 (3.78)
Change in PPG increment at 2 hours	-0.47 (4.74)	0.42 (5.01)	-0.01 (5.15)
Change in PPG increment at 3 hours	-0.20 (4.89)	0.55 (4.95)	0.11 (5.32)
Change in PPG increment at 4 hours	-0.10 (4.47)	0.45 (4.44)	0.16 (4.63)

10. Secondary Outcome

Title	Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile
Description	The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	320	327	320
Mean (Standard Deviation) [mmol/L]	-0.304 (1.928)	-0.231 (1.846)	-0.309 (2.060)

11. Secondary Outcome

Title	Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)
Description	The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Change in PPG breakfast	-0.83 (3.34)	-0.03 (3.30)	-0.31 (3.18)
Change in PPG lunch	-0.59 (3.04)	0.06 (2.98)	-0.33 (3.38)
Change in PPG main evening meal	-0.53 (3.55)	-0.01 (3.56)	-0.14 (3.22)
Change in PPG all meals	-0.65 (2.26)	-0.004 (2.19)	-0.25 (2.33)

12. Secondary Outcome

Title	Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)
Description	The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of analysed=subject with data available data for PPG values and the PG value before the meal (breakfast, lunch, main evening meal).

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Change in PPG increment breakfast	-1.14 (3.64)	0.06 (3.51)	-0.30 (3.16)
Change in PPG increment lunch	-0.67 (3.20)	-0.08 (3.10)	-0.004 (3.31)
Change in PPG increment main evening meal	-0.29 (3.70)	0.34 (3.54)	0.26 (3.49)
Change in PPG increment all meals	-0.72 (2.06)	0.08 (1.98)	-0.02 (2.01)

13. Secondary Outcome

Title	Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile
Description	The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	331	335	331
Geometric Mean (Geometric Coefficient of Variation) [ratio]	0.876 (47.490)	0.875 (40.293)	0.890 (41.978)

14. Secondary Outcome

Title	Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements
Description	The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Change in nocturnal increment-bedtime to 04:00	0.14 (5.66)	0.19 (6.41)	0.45 (5.55)
Change in nocturnal increment-bedtime to breakfast	0.86 (6.21)	0.93 (6.24)	0.33 (5.71)
Change in nocturnal increment-04:00 to breakfast	0.78 (4.95)	1.01 (4.12)	-0.02 (4.17)

15. Secondary Outcome

Title	Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L
Description	Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.
Time Frame	26 weeks after randomisation

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Yes	27.8	19.9	21.6
No	72.2	80.1	78.4

16. Secondary Outcome

Title	Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia
Description	Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.
Time Frame	26 weeks after randomisation

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Yes	24.6	18.8	20.5
No	75.4	81.2	79.5

17. Secondary Outcome

Title	Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia
Description	The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.
Time Frame	26 weeks after randomisation

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Yes	7.6	4.7	8.2
No	92.4	95.3	91.8

18. Secondary Outcome

Title	Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)
Description	Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
HDL cholesterol	0.981 (16.200)	0.998 (17.283)	0.999 (33.056)
LDL cholesterol	1.025 (20.067)	1.053 (22.465)	1.062 (215.570)
Total cholesterol	1.002 (14.561)	1.030 (15.789)	1.020 (15.891)

19. Secondary Outcome

Title	Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)
Description	The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for specified categories.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Daily bolus insulin dose: week 0	25.5 (15.4)	25.4 (14.3)	26.6 (14.8)
Daily bolus insulin dose: Last on-treatment value	31.1 (19.4)	30.5 (18.9)	33.5 (22.5)
Daily basal insulin dose: week 0	25.3 (14.5)	26.7 (15.6)	26.2 (15.0)
Daily basal insulin dose: Last on-treatment value	26.7 (16.6)	27.3 (16.8)	27.2 (17.3)
Total daily insulin dose: week 0	50.8 (26.1)	52.2 (25.2)	53.1 (25.9)
Total daily insulin dose: Last on-treatment value	57.7 (31.4)	57.8 (30.2)	60.4 (34.0)
Daily breakfast bolus insulin dose: Last value	8.8 (6.2)	8.6 (6.0)	9.5 (7.7)
Daily lunch bolus insulin dose: Last value	10.5 (7.0)	10.3 (6.9)	11.2 (7.6)
Daily main evening meal bolus insulin: Last value	11.9 (7.7)	11.6 (7.4)	12.7 (9.1)
Daily other bolus insulin dose: Last value	4.7 (5.1)	4.3 (3.5)	4.2 (3.3)

20. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation
Description	A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Time Frame	Week 0 to week 26 (+7 days)

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Number [events]	649	656	627

21. Secondary Outcome

Title	Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation
Description	A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Time Frame	Week 0 to week 26 (+7 days)

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Number [Injection site reactions]	9	12	10

22. Secondary Outcome

Title	Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall
Description	ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia. NN Classification: Severe:same as per ADA classification Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.
Time Frame	Week 0 to week 26 (+1 day)

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Number [hypoglycaemic episodes]	15760	16579	16520

23. Secondary Outcome

Title	Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
Description	ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.
Time Frame	Week 0 to week 26 (+1 day)

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Daytime hypoglycaemic episodes	14570	15379	15257
Nocturnal hypoglycaemic episodes	1190	1200	1263

24. Secondary Outcome

Title	Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal
Description	ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.
Time Frame	Week 0 to week 26 (+1 day)

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Within 1 hour after meal	624	614	459
Within 2 hours after meal	1314	1470	1224
Within 4 hours after meal	3920	4794	4129
Between 1 (exclusive) to 2 hours (inclusive)	690	856	765
Between 2 (exclusive) to 3 hours (inclusive)	1236	1634	1302
Between 2 (exclusive) to 4 hours (inclusive)	2606	3324	2905
Between 3 (exclusive) to 4 hours (inclusive) hours	1370	1690	1603

25. Secondary Outcome

Title	Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)
Description	The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number analysed=number of subjects with available data for physical examinations at specified timepoints.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Cardiovascular system - Week 0: Normal	97.4	98.8	97.7
Cardiovascular system - Week 0: Abn, NCS	2.6	0.9	2.0
Cardiovascular system - Week 0: Abn, CS	0.0	0.3	0.3
Cardiovascular system - Last value: Normal	97.4	98.8	97.9
Cardiovascular system - Last value: Abn, NCS	2.6	0.9	1.8
Cardiovascular system - Last value: Abn, CS	0.0	0.3	0.3
Nervous system - Week 0: Normal	83.9	86.8	86.3
Nervous system - Week 0: Abn, NCS	15.5	12.9	13.2
Nervous system - Week 0: Abn, CS	0.6	0.3	0.6
Nervous system - Last value: Normal	83.8	87.1	86.8
Nervous system - Last value: Abn, NCS	15.6	12.9	12.4
Nervous system - Last value: Abn, CS	0.6	0.0	0.9
Gastrointestinal system-week 0: Normal	99.7	98.8	98.2
Gastrointestinal system-week 0: Abn, NCS	0.3	0.9	0.9
Gastrointestinal system-week 0: Abn, CS	0.0	0.3	0.9
Gastrointestinal system-Last value: Normal	99.1	97.9	98.5
Gastrointestinal system-Last value: Abn, NCS	0.9	1.2	0.6
Gastrointestinal system-Last value: Abn, CS	0.0	0.9	0.9
Head,ears,eyes,nose,throat,neck:week 0-Normal	95.0	95.6	93.3
Head,ear,eye,nose,throat,neck-week 0:Abn,NCS	4.1	3.8	5.8
Head,ears,eyes,nose,throat,neck-week 0:Abn,CS	0.9	0.6	0.9
Head,ears,eyes,nose,throat,neck-Last value:Normal	95.3	92.9	94.1
Head,ear,eye,nose,throat,neck-Last value:Abn,NCS	3.8	6.2	4.4
Head,ear,eye,nose,throat,neck-Last value:Abn,CS	0.9	0.9	1.5
Musculoskeletal system-week 0: Normal	95.9	97.1	96.2
Musculoskeletal system-week 0: Abn, NCS	4.1	2.9	3.5
Musculoskeletal system-week 0: Abn, CS	0.0	0.0	0.3
Musculoskeletal system-Last value: Normal	96.8	97.4	95.3
Musculoskeletal system-Last value: Abn, NCS	3.2	2.6	3.8
Musculoskeletal system-Last value: Abn, CS	0.0	0.0	0.9
Respiratory system-week 0: Normal	99.4	99.4	99.1
Respiratory system-week 0: Abn, NCS	0.6	0.3	0.6
Respiratory system-week 0: Abn, CS	0.0	0.3	0.3
Respiratory system-Last value: Normal	99.7	99.4	99.4
Respiratory system-Last value: Abn, NCS	0.3	0.3	0.3
Respiratory system-Last value: Abn, CS	0.0	0.3	0.3
Skin-week 0: Normal	91.5	89.7	91.5
Skin-week 0: Abn, NCS	7.3	8.8	7.9
Skin-week 0: Abn, CS	1.2	1.5	0.6
Skin-Last value: Normal	91.5	91.5	92.4
Skin-Last value: Abn, NCS	7.6	6.2	6.5
Skin-Last value: Abn, CS	0.9	2.4	1.2

26. Secondary Outcome

Title	Change From Baseline in Blood Pressure 26 Weeks After Randomisation
Description	Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number of subjects analysed=subjects with available data for blood pressure

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Diastolic blood pressure	0.5 (8.3)	0.2 (7.8)	0.8 (7.9)
Systolic blood pressure	0.6 (12.5)	1.4 (10.8)	0.8 (12.9)

27. Secondary Outcome

Title	Change From Baseline in Pulse 26 Weeks After Randomisation
Description	Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number of subjects analysed=subjects with available data for pulse.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Mean (Standard Deviation) [beats/minute]	0.0 (8.8)	-0.7 (9.3)	0.7 (8.3)

28. Secondary Outcome

Title	Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation
Description	The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number analysed=number of subjects with available data for electrocardiogram at specified timepoints.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Week 0: Normal	80.7	81.8	84.2
Week 0: Abn, NCS	19.3	17.6	15.8
Week 0: Abn, CS	0.0	0.6	0.0
Last on-treatment value: Normal	80.8	84.0	82.3
Last on-treatment value: Abn, NCS	19.2	15.1	17.1
Last on-treatment value: Abn, CS	0.0	0.9	0.6

29. Secondary Outcome

Title	Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation
Description	The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number analysed=number of subjects with available data for fundoscopy/fundus photography at specified timepoints.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Left eye-Week 0: Normal	65.8	68.0	69.3
Left eye-Week 0: Abn, NCS	26.9	23.5	23.4
Left eye-Week 0: Abn, CS	7.3	8.5	7.3
Left eye-Last on-treatment value: Normal	62.5	69.4	69.3
Left eye-Last on-treatment value: Abn, NCS	29.7	21.0	21.1
Left eye-Last on-treatment value: Abn, CS	7.8	9.6	9.6
Right eye-Week 0: Normal	65.2	68.9	67.0
Right eye-Week 0: Abn, NCS	27.8	22.3	25.4
Right eye-Week 0: Abn, CS	7.0	8.8	7.6
Right eye-Last on-treatment value: Normal	64.0	67.9	68.7
Right eye-Last on-treatment value: Abn, NCS	29.1	22.5	22.6
Right eye-Last on-treatment value: Abn, CS	6.9	9.6	8.7

30. Secondary Outcome

Title	Change From Baseline in Erythrocytes 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for erythrocytes measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Mean (Standard Deviation) [number of erythrocytes 10^12/L]	-0.01 (0.24)	-0.03 (0.26)	-0.02 (0.26)

31. Secondary Outcome

Title	Change From Baseline in Haematocrit 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haematocrit measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Mean (Standard Deviation) [percentage of red blood cells in blood]	-0.48 (2.58)	-0.52 (2.41)	-0.57 (2.45)

32. Secondary Outcome

Title	Change From Baseline in Haemoglobin 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haemoglobin measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Mean (Standard Deviation) [mmol/L]	-0.04 (0.51)	-0.04 (0.46)	-0.05 (0.50)

33. Secondary Outcome

Title	Change From Baseline in Leukocytes 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for leukocytes measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Mean (Standard Deviation) [Number of leukocytes 10^9/L]	-0.17 (1.63)	-0.03 (1.52)	-0.01 (1.46)

34. Secondary Outcome

Title	Change From Baseline in Thrombocytes 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for thrombocytes measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	339
Mean (Standard Deviation) [Number of thrombocytes 10^9/L]	-0.7 (40.0)	-2.0 (36.3)	-1.8 (33.7)

35. Secondary Outcome

Title	Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alanine aminotransferase measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	340
Mean (Standard Deviation) [U/L]	1.3 (10.1)	0.9 (9.0)	0.6 (11.6)

36. Secondary Outcome

Title	Change From Baseline in Albumin 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for albumin measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	340
Mean (Standard Deviation) [g/dL]	-0.02 (0.25)	-0.05 (0.25)	-0.03 (0.25)

37. Secondary Outcome

Title	Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alkaline phosphatase measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	340
Mean (Standard Deviation) [U/L]	2.1 (18.9)	1.4 (12.3)	-0.2 (14.4)

38. Secondary Outcome

Title	Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for aspartate aminotransferase measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	339
Mean (Standard Deviation) [U/L]	-0.0 (9.5)	-0.1 (9.4)	-0.3 (13.3)

39. Secondary Outcome

Title	Change From Baseline in Total Bilirubin 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total bilirubin measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	340
Mean (Standard Deviation) [umol/L]	-0.1 (3.3)	-0.2 (3.9)	-0.2 (3.3)

40. Secondary Outcome

Title	Change From Baseline in Potassium 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for potassium measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	339
Mean (Standard Deviation) [mmol/L]	0.01 (0.43)	0.04 (0.42)	0.04 (0.43)

41. Secondary Outcome

Title	Change From Baseline in Creatinine 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for creatinine measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	340
Mean (Standard Deviation) [umol/L]	2.0 (8.8)	1.8 (7.5)	1.8 (15.6)

42. Secondary Outcome

Title	Change From Baseline in Total Protein 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total protein measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	340
Mean (Standard Deviation) [g/dL]	0.03 (0.40)	0.02 (0.37)	-0.02 (0.36)

43. Secondary Outcome

Title	Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation
Description	Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for urinary albumin and creatinine measurement.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	339	340
Mean (Standard Deviation) [mg/mmol]	0.636 (7.361)	-0.379 (11.095)	0.656 (12.739)

44. Secondary Outcome

Title	Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation
Description	Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number analysed=number of subjects with available data for ketones values.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Week 0: Negative	96.2	97.1	92.7
Week 0: Positive	0.0	0.0	0.0
Week 0: Trace	2.0	1.8	5.3
Week 0: 1+	1.8	1.2	1.8
Week 0: 2+	0.0	0.0	0.3
Week 0: 3+	0.0	0.0	0.0
Last on-treatment value: Negative	92.3	89.7	90.0
Last on-treatment value:Positive	0.0	0.0	0.0
Last on-treatment value: Trace	5.0	6.5	6.5
Last on-treatment value:1+	2.1	3.2	2.9
Last on-treatment value: 2+	0.6	0.6	0.6
Last on-treatment value: 3+	0.0	0.0	0.0

45. Secondary Outcome

Title	Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation
Description	Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number analysed=number of subjects with available data for protein values.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Week 0: Negative	82.2	79.5	80.4
Week 0: Positive	0.0	0.0	0.0
Week 0: Trace	12.0	14.4	13.5
Week 0: 1+	4.4	4.1	3.5
Week 0: 2+	1.2	1.2	2.0
Week 0: 3+	0.3	0.9	0.6
Last on-treatment value: Negative	83.5	82.6	78.8
Last on-treatment value:Positive	0.0	0.0	0.0
Last on-treatment value: Trace	8.6	10.9	12.4
Last on-treatment value:1+	5.9	4.7	6.5
Last on-treatment value: 2+	1.5	1.2	2.1
Last on-treatment value: 3+	0.6	0.6	0.3

46. Secondary Outcome

Title	Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation
Description	Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number analysed=number of subjects with available data for erythrocytes values.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Week 0: Negative	95.3	93.3	93.3
Week 0: Positive	0.0	0.0	0.0
Week 0: Trace	1.8	2.3	3.2
Week 0: 1+	0.9	1.5	2.0
Week 0: 2+	1.2	0.9	0.6
Week 0: 3+	0.9	2.1	0.9
Last on-treatment value: Negative	93.5	91.7	91.8
Last on-treatment value:Positive	0.0	0.0	0.0
Last on-treatment value: Trace	2.7	3.8	2.6
Last on-treatment value:1+	1.5	0.9	2.1
Last on-treatment value: 2+	0.6	2.1	1.8
Last on-treatment value: 3+	1.8	1.5	1.8

47. Secondary Outcome

Title	Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation
Description	Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on the SAS. Number analysed=number of subjects with available data for anti-insulin aspart antibody.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	342	341	342
Anti-insulin aspart specific antibodies	0.033 (0.777)	-0.027 (1.077)	-0.013 (1.568)
Cross-reacting to human insulin	-0.972 (6.028)	-1.799 (6.812)	-1.427 (5.527)

48. Secondary Outcome

Title	Change From Baseline in Body Weight 26 Weeks After Randomisation
Description	The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number of subjects analysed=subject with data available for body weight.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Mean (Standard Deviation) [kg]	1.43 (2.66)	1.14 (2.95)	1.24 (2.60)

49. Secondary Outcome

Title	Change From Baseline in Body Mass Index 26 Weeks After Randomisation
Description	The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame	Week 0, week 26

Outcome Measure Data

Analysis Population Description

Analysis was based on SAS. Number of subjects analysed=subject with data available for body mass index.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Measure Participants	340	340	340
Mean (Standard Deviation) [kg/m^2]	0.49 (0.91)	0.39 (1.02)	0.43 (0.89)

Adverse Events

Time Frame	Week 0 to week 26 (+7 days)
Adverse Event Reporting Description	A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Arm/Group Title	Faster Aspart (Meal)		Faster Aspart (Post)		NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.		Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.		After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
All Cause Mortality
	Faster Aspart (Meal)		Faster Aspart (Post)		NovoRapid (Meal)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/342 (0%)		0/341 (0%)		0/342 (0%)
Serious Adverse Events
	Faster Aspart (Meal)		Faster Aspart (Post)		NovoRapid (Meal)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/342 (5.8%)		17/341 (5%)		17/342 (5%)
Gastrointestinal disorders
Gastritis	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Gastrooesophageal reflux disease	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
General disorders
Chest pain	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Hepatobiliary disorders
Cholecystitis	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Infections and infestations
Cellulitis	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Diverticulitis	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Pilonidal cyst	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Urinary tract infection	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Injury, poisoning and procedural complications
Extradural haematoma	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Fall	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Femoral neck fracture	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Forearm fracture	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Postoperative ileus	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Radius fracture	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Road traffic accident	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Skull fractured base	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Tendon rupture	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Ulna fracture	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Wrong drug administered	0/342 (0%)	0	0/341 (0%)	0	2/342 (0.6%)	2
Investigations
Blood glucose fluctuation	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Metabolism and nutrition disorders
Diabetic metabolic decompensation	1/342 (0.3%)	1	1/341 (0.3%)	1	1/342 (0.3%)	1
Hypoglycaemia	8/342 (2.3%)	8	3/341 (0.9%)	6	6/342 (1.8%)	6
Hypoglycaemia unawareness	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Musculoskeletal and connective tissue disorders
Bursitis	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Collagen disorder	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Intervertebral disc disorder	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Intervertebral disc protrusion	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Trigger finger	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Nervous system disorders
Cerebrovascular accident	0/342 (0%)	0	1/341 (0.3%)	1	0/342 (0%)	0
Diabetic neuropathy	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Hypoglycaemic coma	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Hypoglycaemic seizure	2/342 (0.6%)	2	1/341 (0.3%)	1	0/342 (0%)	0
Hypoglycaemic unconsciousness	2/342 (0.6%)	2	3/341 (0.9%)	3	2/342 (0.6%)	2
Polyneuropathy	0/342 (0%)	0	2/341 (0.6%)	2	0/342 (0%)	0
Psychiatric disorders
Depression	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Surgical and medical procedures
Haemorrhoid operation	1/342 (0.3%)	1	0/341 (0%)	0	0/342 (0%)	0
Inguinal hernia repair	0/342 (0%)	0	0/341 (0%)	0	1/342 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Faster Aspart (Meal)		Faster Aspart (Post)		NovoRapid (Meal)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	154/342 (45%)		152/341 (44.6%)		161/342 (47.1%)
Infections and infestations
Influenza	21/342 (6.1%)	22	14/341 (4.1%)	14	10/342 (2.9%)	10
Upper respiratory tract infection	30/342 (8.8%)	38	26/341 (7.6%)	34	27/342 (7.9%)	34
Viral upper respiratory tract infection	73/342 (21.3%)	101	70/341 (20.5%)	100	80/342 (23.4%)	118
Investigations
Blood glucose decreased	58/342 (17%)	81	67/341 (19.6%)	83	68/342 (19.9%)	82

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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