onset®7: Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02670915
• Collaborator: (none)
• Enrollment: 834
• Locations: 155
• Arms: 3
• Actual Duration (Months): 21.9
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.

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: 834 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 Children and Adolescents With Type 1 Diabetes
• Actual Study Start Date: May 4, 2016
• Actual Primary Completion Date: Feb 5, 2018
• Actual Study Completion Date: Mar 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meal-time faster-acting insulin aspart and insulin degludec	Drug: Faster-acting insulin aspart; For subcutaneous (s.c., under the skin) injection once daily.; Drug: insulin degludec; For subcutaneous (s.c., under the skin) injection once daily.
Active Comparator: Meal-time NovoRapid® (insulin aspart) and insulin degludec	Drug: insulin aspart; For subcutaneous (s.c., under the skin) injection once daily.; Drug: insulin degludec; For subcutaneous (s.c., under the skin) injection once daily.
Experimental: Post-meal faster-acting insulin aspart and insulin degludec	Drug: Faster-acting insulin aspart; For subcutaneous (s.c., under the skin) injection once daily.; Drug: insulin degludec; For subcutaneous (s.c., under the skin) injection once daily.

Outcome Measures

Primary Outcome Measures

1. Change in the Percentage of HbA1c [Week 0, Week 26]

   Change from baseline (week 0) in glycosylated haemoglobin (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 participant-site contact and included data collected after a subject discontinued trial product.

Secondary Outcome Measures

1. Change in 8-point SMPG Profile: Mean PPG Over All Three Meals [Week 0, Week 26]

   Change from baseline (week 0) in mean post prandial glucose (PPG) over all three meals was evaluated after 26 weeks of randomisation. PPG for each meal (breakfast, lunch and main evening meal) was recorded by the participant as part of the 8-point self-measured plasma glucose (SMPG) profile. Mean PPG over all three meals was derived as the mean of all corresponding mean meal. The results are based on the last in-trial value.

2. Change in 8-point SMPG Profile: PPG Increment Over All Three Meals [Week 0, Week 26]

   Change from baseline (week 0) in mean PPG increment over all three meals was evaluated after 26 weeks of randomisation. Postprandial glucose (PPG) increment for each meal (breakfast, lunch and main evening meal) was derived from the 8-point profile as the difference between PPG (1 hour after the meal) values and the plasma glucose (PG) value before meal. The mean of the derived increments was then calculated separately for each meal. Mean PPG increment over all three meals was derived as the mean of all corresponding mean meal increments. The results are based on the last in-trial value.

3. Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG [Week 0, Week 26]

   Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG was evaluated after 26 weeks of randomisation. PPG for each meal was recorded by the participant as part of the 8-point SMPG profile. The results are based on the last in-trial value.

4. Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment [Week 0, Week 26]

   Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG increment was evaluated after 26 weeks of randomisation. PPG increment for each meal was derived from the 8-point profile as the difference between PPG values (1 hour after the meal) and the PG value before meal. The results are based on the last in-trial value.

5. Change in 8-point SMPG Profile: Mean of the 8-point Profile [Week 0, Week 26]

   Change from baseline (week 0) in mean of the 8-point SMPG profile was evaluated after 26 weeks of randomisation. SMPG values were recorded at 8 time-points on two consecutive days: before and after (60 minute after the start of the meal) breakfast, lunch and main evening meal, before bedtime, and before breakfast on the next day. Mean of the 8-point profile was derived as the mean of all corresponding mean SMPG recorded at 8 different time points. The results are based on the last in-trial value.

6. Fluctuation in the 8-point SMPG Profile [Week 26]

   Fluctuation in the 8-point SMPG profile was evaluated after 26 weeks of randomisation. Fluctuation in 8-point SMPG profile was the average absolute difference from the mean of the SMPG profile. The results are based on the last in-trial value.

7. Change in FPG [Week 0, Week 26]

   Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.

8. Change in 1,5-anhydroglucitol [Week 0, Week 26]

   Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.

9. Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines [Week 26]

   Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.

10. Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia [Week 26]

    Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to ISPAD guidelines, without severe hypoglycaemia was evaluated after 26 weeks of randomisation. Severe hypoglycaemia according to ISPAD guidelines: hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose). The results are based on the last in-trial value.

11. Insulin Dose (Units/Day): Total Basal [Week 26]

    Total basal insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised NovoRapid®/NovoLog® / faster aspart and no later than 7 days after the day of last dose of NovoRapid®/NovoLog® / faster aspart. The on-treatment observation period includes data collected up to and including 7 days after treatment discontinuation. Number of participants analysed = number of participants contributed to the analysis. Analysis population description: Safety analysis set (SAS) included all participants receiving at least one dose of the investigational product (faster aspart) or its comparator (NovoRapid®/NovoLog®).

12. Insulin Dose (Units/Day): Total Bolus [Week 26]

    Total bolus insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

13. Insulin Dose (Units/Day): Individual Meal Insulin Dose [Week 26]

    Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.

14. Insulin Dose (Units/kg/Day): Total Basal [Week 26]

    Total basal insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

15. Insulin Dose (Units/kg/Day): Total Bolus [Week 26]

    Total bolus insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

16. Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose [Week 26]

    Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

17. Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) [Week 0, Week 26]

    Change from baseline (week 0) in the time spent in low IG (<=3.9 mmol/L [70 mg/dL]) based on continuous glucose monitoring (CGM) was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

18. Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) [Week 26]

    Incidence of episodes (number of episodes per 24 hours) with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was calculated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

19. Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) [Week 26]

    Percentage of time spent with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

20. Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included [Week 26]

    Percentage of time spent within IG target 4.0-10.0 mmol/L (71-180 mg/dL), both included based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

21. Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) [Week 0, Week 26]

    Change from baseline (week 0) in mean IG increment (0-1 hours and 0-2 hours after start of the meal) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.

22. Change in Mean IG Peak After Start of Meal [Week 0, Week 26]

    Change from baseline (week 0) in mean IG peak after start of meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.

23. Change in Mean Time to the IG Peak After Meal [Week 0, Week 26]

    Change from baseline (week 0) in mean time to the IG peak after meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of subjects wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.

24. Change in 30-minute PPG [Week 0, Week 26]

    Change from baseline (week 0) in 30-minute PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 30-minute after the meal intake at the visit. The results are based on the last in-trial value.

25. Change in 30-minute PPG Increment [Week 0, Week 26]

    Change from baseline (week 0) in 30-minute PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 30-minute (after the meal) at the visit. PPG increment was derived as 30-minute PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.

26. Change in 1-hour PPG [Week 0, Week 26]

    Change from baseline (week 0) in 1-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 1-hour after the meal intake at the visit. The results are based on the last in-trial value.

27. Change in 1-hour PPG Increment [Week 0, Week 26]

    Change from baseline (week 0) in 1-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 1-hour (after the meal) at the visit. PPG increment was derived as 1-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.

28. Change in 2-hour PPG [Week 0, Week 26]

    Change from baseline (week 0) in 2-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 2-hour after the meal intake at the visit. The results are based on the last in-trial value.

29. Change in 2-hour PPG Increment [Week 0, Week 26]

    Change from baseline (week 0) in 2-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 2-hour (after the meal) at the visit. PPG increment was derived as 2-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.

30. Change in AUCIG,0-15min [Week 0, Week 26]

    Change in area under the IG curve 0-15 minutes post meal (AUCIG,0-15min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. Interstitial glucose (IG) was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

31. Change in AUCIG,0-30min [Week 0, Week 26]

    Change in area under the IG curve 0-30 minutes post meal (AUCIG,0-30min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

32. Change in AUCIG,0-1h [Week 0, Week 26]

    Change in area under the IG curve 0-1 hour post meal (AUCIG,0-1h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

33. Change in AUCIG,0-2h [Week 0, Week 26]

    Change in area under the IG curve 0-2 hours post meal (AUCIG,0-2h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

34. Change in AUCIG,0-4h [Week 0, Week 26]

    Change in area under the IG curve 0-4 hours post meal (AUCIG,0-4h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.

35. Change in Time to the IG Peak After Start of Meal [Week 0, Week 26]

    Change in time to the IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.

36. Change in IG Peak After Start of Meal [Week 0, Week 26]

    Change in IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.

37. Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total [Week 0-26]

    Treatment emergent: if the onset of the episode occurred on or after the first day of treatment with investigational medicinal product (IMP) after randomisation, and no later than 1 day after the last day on IMP. Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic: episode during which typical symptoms of hypoglycaemia are accompanied by a PG level ≤3.9 mmol/L. 3) Asymptomatic: episode not accompanied by typical symptoms of hypoglycaemia, but with a PG level ≤3.9 mmol/L. 4) Probable symptomatic: an episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. 5) Pseudo-hypoglycaemia: episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a PG level >3.9mmol/L, but approaching that level. The results are based on the on-treatment period.

38. Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.

39. Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.

40. Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) Symptomatic blood glucose (BG) confirmed: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3) Asymptomatic BG confirmed: episode that is BG confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG confirmed symptomatic: an episode that is severe according to the ISPAD classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG confirmed: an episode that is BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG confirmed: an episode that is severe according to the ISPAD Classification or BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. The results are based on the on-treatment period.

41. Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.

42. Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.

43. Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.

44. Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.

45. Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.

46. Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.

47. Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.

48. Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.

49. Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.

50. Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification [Week 0-26]

    Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.

51. Number of Treatment Emergent Adverse Events (AEs) [Week 0-26]

    Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP (faster aspart or NovoRapid®/NovoLog®) and excluding the events occurring in the run-in period. The results are based on the on-treatment period.

52. Number of Treatment Emergent Injection Site Reactions [Week 0-26]

    Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP and excluding the events occurring in the run-in period. The results are based on the on-treatment period.

53. Change in Physical Examination [Week 0, Week 26]

    The following physical examinations were done: 1) Cardiovascular system. 2) Central and peripheral nervous system. 3) Gastrointestinal system including the mouth. 4) General appearance. 5) Head, ears, eyes, nose, throat and neck. 6) Musculoskeletal system. 7) Respiratory system. 8) Skin. Presented results are number of participants with the following outcomes: normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Presented results are baseline (week 0) and last on-treatment values. Number of participants analysed = number of participants contributed to the analysis.

54. Change in Vital Sign: Blood Pressure [Week 0, Week 26]

    Change from baseline (week 0) in blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.

55. Change in Vital Sign: Pulse [Week 0, Week 26]

    Change from baseline (week 0) in pulse was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.

56. Change in Body Weight [Week 0, Week 26]

    Change from baseline (week 0) in body weight was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

57. Change in Height [Week 0, Week 26]

    Change from baseline (week 0) in height was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

58. Change in Body Mass Index [Week 0, Week 26]

    Change from baseline (week 0) in body mass index (BMI) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

59. Change in SD Score of Body Weight [Week 0, Week 26]

    Change from baseline (week 0) in standard deviation (SD) score of body weight was evaluated after 26 weeks of randomisation. SD-scores are defined to be able to normalise the body weight in the various age groups. To estimate the growth of children, standardised weight is calculated for each year of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. The SD scores are derived from the age and sex of the subjects and the body weight together with growth curves defined for a reference population. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

60. Change in SD Score of Body Mass Index [Week 0, Week 26]

    Change from baseline (week 0) in SD score of BMI was evaluated after 26 weeks of randomisation. SD scores for BMI were determined in a similar way as SD scores for weight by use of a suitable reference population based on age and sex. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

61. Change in Haematology: Haemoglobin [Week 0, Week 26]

    Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

62. Change in Haematology: Haematocrit [Week 0, Week 26]

    Change from baseline (week 0) in haematocrit was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

63. Change in Haematology: Erythrocytes [Week 0, Week 26]

    Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

64. Change in Haematology: Thrombocytes [Week 0, Week 26]

    Change from baseline (week 0) in thrombocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

65. Change in Haematology: Leukocytes [Week 0, Week 26]

    Change from baseline (week 0) in leukocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

66. Change in Biochemistry: Creatinine [Week 0, Week 26]

    Change from baseline (week 0) in creatinine was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

67. Change in Biochemistry: Alanine Aminotransferase (ALT) [Week 0, Week 26]

    Change from baseline (week 0) in ALT was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

68. Change in Biochemistry: Aspartate Aminotransferase (AST) [Week 0, Week 26]

    Change from baseline (week 0) in AST was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

69. Change in Biochemistry: Alkaline Phosphatase (AP) [Week 0, Week 26]

    Change from baseline (week 0) in AP was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

70. Change in Biochemistry: Sodium [Week 0, Week 26]

    Change from baseline (week 0) in sodium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

71. Change in Biochemistry: Potassium [Week 0, Week 26]

    Change from baseline (week 0) in potassium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

72. Change in Biochemistry: Albumin [Week 0, Week 26]

    Change from baseline (week 0) in albumin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

73. Change in Biochemistry: Total Bilirubin [Week 0, Week 26]

    Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.

74. Change in Lipid Profile: Total Cholesterol [Week 0, Week 26]

    Change from baseline (week 0) in total cholesterol after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.

75. Change in Lipid Profile: High Density Lipoproteins (HDL) [Week 0, Week 26]

    Change from baseline (week 0) in HDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.

76. Change in Lipid Profile: Low Density Lipoproteins (LDL) [Week 0, Week 26]

    Change from baseline (week 0) in LDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.

77. Change in Anti-insulin Aspart Antibody Development: Specific [Week 0, Week 26]

    Change from baseline (week 0) in 'antibodies specific for insulin aspart' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.

78. Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin [Week 0, Week 26]

    Change from baseline (week 0) in 'antibodies for insulin aspart, those cross-reacting with human insulin' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.

79. Change in Anti-insulin Aspart Antibody Development: Total [Week 0, Week 26]

    Change from baseline (week 0) in 'total anti-insulin aspart antibodies (specific for insulin aspart and those cross-reacting with human insulin)' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Phoenix	Arizona	United States	85053
2	Novo Nordisk Investigational Site	Tucson	Arizona	United States	85724
3	Novo Nordisk Investigational Site	Long Beach	California	United States	90806
4	Novo Nordisk Investigational Site	Los Angeles	California	United States	90027
5	Novo Nordisk Investigational Site	Sacramento	California	United States	95821
6	Novo Nordisk Investigational Site	Ventura	California	United States	93003
7	Novo Nordisk Investigational Site	Aurora	Colorado	United States	80045
8	Novo Nordisk Investigational Site	Gainesville	Florida	United States	32608
9	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32207
10	Novo Nordisk Investigational Site	Orlando	Florida	United States	32806
11	Novo Nordisk Investigational Site	Tallahassee	Florida	United States	32308
12	Novo Nordisk Investigational Site	Tampa	Florida	United States	33612
13	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30339
14	Novo Nordisk Investigational Site	Boise	Idaho	United States	83712
15	Novo Nordisk Investigational Site	Idaho Falls	Idaho	United States	83404-7596
16	Novo Nordisk Investigational Site	Springfield	Illinois	United States	62702
17	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
18	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21229
19	Novo Nordisk Investigational Site	Boston	Massachusetts	United States	02215
20	Novo Nordisk Investigational Site	Minneapolis	Minnesota	United States	55416
21	Novo Nordisk Investigational Site	Minneapolis	Minnesota	United States	55455
22	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89128
23	Novo Nordisk Investigational Site	Neptune	New Jersey	United States	07753
24	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
25	Novo Nordisk Investigational Site	Mineola	New York	United States	11501
26	Novo Nordisk Investigational Site	Raleigh	North Carolina	United States	27610
27	Novo Nordisk Investigational Site	Fargo	North Dakota	United States	58122
28	Novo Nordisk Investigational Site	Columbus	Ohio	United States	43205
29	Novo Nordisk Investigational Site	Tulsa	Oklahoma	United States	74135
30	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
31	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19107
32	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
33	Novo Nordisk Investigational Site	Sioux Falls	South Dakota	United States	57105
34	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
35	Novo Nordisk Investigational Site	Austin	Texas	United States	78731
36	Novo Nordisk Investigational Site	Dallas	Texas	United States	75231
37	Novo Nordisk Investigational Site	Dallas	Texas	United States	75235
38	Novo Nordisk Investigational Site	Salt Lake City	Utah	United States	84132
39	Novo Nordisk Investigational Site	Pleven		Bulgaria	5800
40	Novo Nordisk Investigational Site	Sofia		Bulgaria	1407
41	Novo Nordisk Investigational Site	Sofia		Bulgaria	1606
42	Novo Nordisk Investigational Site	Varna		Bulgaria	9010
43	Novo Nordisk Investigational Site	Hradec Kralove		Czechia	50005
44	Novo Nordisk Investigational Site	Opava		Czechia	746001
45	Novo Nordisk Investigational Site	Ostrava - Poruba		Czechia	70852
46	Novo Nordisk Investigational Site	Pardubice		Czechia	53203
47	Novo Nordisk Investigational Site	Praha		Czechia	10034
48	Novo Nordisk Investigational Site	Usti nad Labem		Czechia	40113
49	Novo Nordisk Investigational Site	Tallinn		Estonia	13419
50	Novo Nordisk Investigational Site	Tartu		Estonia	51014
51	Novo Nordisk Investigational Site	Espoo		Finland	02740
52	Novo Nordisk Investigational Site	OYS		Finland	90029
53	Novo Nordisk Investigational Site	Seinäjoki		Finland	60220
54	Novo Nordisk Investigational Site	Bochum		Germany	44791
55	Novo Nordisk Investigational Site	Freiburg		Germany	79106
56	Novo Nordisk Investigational Site	Hannover		Germany	30173
57	Novo Nordisk Investigational Site	Ludwigshafen		Germany	67059
58	Novo Nordisk Investigational Site	Münster		Germany	48155
59	Novo Nordisk Investigational Site	Neuwied		Germany	56564
60	Novo Nordisk Investigational Site	Oldenburg		Germany	23758
61	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach		Germany	66386
62	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh	India	500003
63	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh	India	500072
64	Novo Nordisk Investigational Site	Ahmedabad	Gujarat	India	380007
65	Novo Nordisk Investigational Site	Kochi	Kerala	India	682041
66	Novo Nordisk Investigational Site	Indore	Madhya Pradesh	India	452010
67	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	400010
68	Novo Nordisk Investigational Site	Pune	Maharashtra	India	411001
69	Novo Nordisk Investigational Site	Chennai	Tamil Nadu	India	600 013
70	Novo Nordisk Investigational Site	Kolkata		India	700026
71	Novo Nordisk Investigational Site	New Delhi		India	110060
72	Novo Nordisk Investigational Site	Beer Sheva		Israel	84101
73	Novo Nordisk Investigational Site	Haifa		Israel	31096
74	Novo Nordisk Investigational Site	Holon		Israel	58100
75	Novo Nordisk Investigational Site	Petah Tikva		Israel	49202
76	Novo Nordisk Investigational Site	Tel Aviv		Israel
77	Novo Nordisk Investigational Site	Zerifin		Israel	70300
78	Novo Nordisk Investigational Site	Ancona		Italy	60123
79	Novo Nordisk Investigational Site	Catanzaro		Italy	88100
80	Novo Nordisk Investigational Site	Chieti		Italy	66100
81	Novo Nordisk Investigational Site	Napoli		Italy	80131
82	Novo Nordisk Investigational Site	Verona		Italy	37126
83	Novo Nordisk Investigational Site	Amagasaki-shi, Hyogo		Japan	661-0965
84	Novo Nordisk Investigational Site	Chuo-shi, Yamanashi		Japan	409 3898
85	Novo Nordisk Investigational Site	Fukuoka		Japan	830-0011
86	Novo Nordisk Investigational Site	Hiroshima-shi, Hiroshima		Japan	734-8530
87	Novo Nordisk Investigational Site	Iruma-gun, Saitama		Japan	350 0495
88	Novo Nordisk Investigational Site	Kitakyushu,Fukuoka		Japan	8078556
89	Novo Nordisk Investigational Site	Kitakyushu-shi, Fukuoka		Japan	806-8501
90	Novo Nordisk Investigational Site	Kobe-shi, Hyogo		Japan	650-0047
91	Novo Nordisk Investigational Site	Kobe-shi, Hyogo		Japan	657-0846
92	Novo Nordisk Investigational Site	Kochi-shi, Kochi		Japan	780 0952
93	Novo Nordisk Investigational Site	Kofu, Yamanashi		Japan	400-0027
94	Novo Nordisk Investigational Site	Kumamoto-shi, Kumamoto		Japan	860 8556
95	Novo Nordisk Investigational Site	Kure-shi, Hiroshima		Japan	737-0023
96	Novo Nordisk Investigational Site	Kyoto		Japan	602-8566
97	Novo Nordisk Investigational Site	Maebashi-shi, Gunma		Japan	371-8511
98	Novo Nordisk Investigational Site	Matsumoto-shi, Nagano,		Japan	399-8701
99	Novo Nordisk Investigational Site	Matsuyama-shi, Ehime		Japan	790-8524
100	Novo Nordisk Investigational Site	Musashino-shi, Tokyo		Japan	180 0023
101	Novo Nordisk Investigational Site	Niigata-shi, Niigata		Japan	950 1197
102	Novo Nordisk Investigational Site	Niigata-shi, Niigata		Japan	951 8520
103	Novo Nordisk Investigational Site	Okayama Kita-ku, Okayama		Japan	700-8607
104	Novo Nordisk Investigational Site	Okayama-shi, Okayama		Japan	700-0013
105	Novo Nordisk Investigational Site	Okayama-shi, Okayama		Japan	701-1192
106	Novo Nordisk Investigational Site	Osaka-shi, Osaka		Japan	545 8586
107	Novo Nordisk Investigational Site	Ota-shi, Gunma		Japan	373-8585
108	Novo Nordisk Investigational Site	Otsu-shi, Shiga		Japan	520-0804
109	Novo Nordisk Investigational Site	Saga-shi, Saga		Japan	840-0801
110	Novo Nordisk Investigational Site	Sendai-shi, Miyagi		Japan	980 8574
111	Novo Nordisk Investigational Site	Suzaka-shi ,Nagano		Japan	382-0091
112	Novo Nordisk Investigational Site	Tochigi		Japan	329-0498
113	Novo Nordisk Investigational Site	Tokyo		Japan	101-8309
114	Novo Nordisk Investigational Site	Tokyo		Japan	157 8535
115	Novo Nordisk Investigational Site	Tokyo		Japan	162 8666
116	Novo Nordisk Investigational Site	Tsu-shi, Mie		Japan	514 0125
117	Novo Nordisk Investigational Site	Yokohama-shi, Kanagawa		Japan	232-0024
118	Novo Nordisk Investigational Site	Yokosuka-shi, Kanagawa		Japan	238-8567
119	Novo Nordisk Investigational Site	Riga		Latvia	LV1004
120	Novo Nordisk Investigational Site	Kaunas		Lithuania	50009
121	Novo Nordisk Investigational Site	Gdansk		Poland	80-952
122	Novo Nordisk Investigational Site	Warszawa		Poland	04-730
123	Novo Nordisk Investigational Site	Warszawa		Poland	04-736
124	Novo Nordisk Investigational Site	Wroclaw		Poland	50-368
125	Novo Nordisk Investigational Site	San Juan		Puerto Rico	00927
126	Novo Nordisk Investigational Site	Kazan		Russian Federation	420073
127	Novo Nordisk Investigational Site	Moscow		Russian Federation	117036
128	Novo Nordisk Investigational Site	Moscow		Russian Federation	125373
129	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630048
130	Novo Nordisk Investigational Site	Rostov-on-Don		Russian Federation	344013
131	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	191036
132	Novo Nordisk Investigational Site	Samara		Russian Federation	443079
133	Novo Nordisk Investigational Site	Saratov		Russian Federation	410054
134	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
135	Novo Nordisk Investigational Site	Ufa		Russian Federation	450106
136	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
137	Novo Nordisk Investigational Site	Belgrade		Serbia	11070
138	Novo Nordisk Investigational Site	Nis		Serbia	18 000
139	Novo Nordisk Investigational Site	Novi Sad		Serbia	21000
140	Novo Nordisk Investigational Site	Adana		Turkey	01130
141	Novo Nordisk Investigational Site	Antalya		Turkey	07059
142	Novo Nordisk Investigational Site	Istanbul		Turkey	34093
143	Novo Nordisk Investigational Site	Istanbul		Turkey	34668
144	Novo Nordisk Investigational Site	İzmir		Turkey	35040
145	Novo Nordisk Investigational Site	Izmir		Turkey	35340
146	Novo Nordisk Investigational Site	Samsun		Turkey	55139
147	Novo Nordisk Investigational Site	Dnipro		Ukraine	49023
148	Novo Nordisk Investigational Site	Ivano-Frankivsk		Ukraine	76018
149	Novo Nordisk Investigational Site	Kharkiv		Ukraine	61093
150	Novo Nordisk Investigational Site	Kharkiv		Ukraine	61153
151	Novo Nordisk Investigational Site	Kiev		Ukraine	01021
152	Novo Nordisk Investigational Site	Kyiv		Ukraine	04114
153	Novo Nordisk Investigational Site	Lviv		Ukraine	79010
154	Novo Nordisk Investigational Site	Vinnytsia		Ukraine	21010
155	Novo Nordisk Investigational Site	Zaporizhzhia		Ukraine	69063

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Aug 17, 2018
• Statistical Analysis Plan - Aug 17, 2018

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

• Bode BW, Iotova V, Kovarenko M, Laffel LM, Rao PV, Deenadayalan S, Ekelund M, Larsen SF, Danne T. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. Diabetes Care. 2019 Jul;42(7):1255-1262. doi: 10.2337/dc19-0009. Epub 2019 May 10.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02670915
• Other Study ID Numbers: NN1218-4101; 2014-002568-33; U1111-1158-1170; JapicCTI-163248
• First Posted: Feb 2, 2016
• Last Update Posted: Jun 5, 2019
• Last Verified: May 1, 2019

• 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 150 sites in 17 countries(number of sites with screened/randomised subjects)-Bulgaria: 4/4; Czech Republic: 6/6; Estonia: 2/2; Finland: 3/3; Germany: 6/6; India: 7/7; Israel: 6/6; Italy: 5/5; Japan: 34/34; Latvia: 1/1; Lithuania: 1/1; Poland: 4/4; Russia: 11/11; Serbia: 4/4; Turkey: 7/7; Ukraine: 9/9; United States: 40/39
Pre-assignment Detail	12-week run-in period: Participants were switched from previous insulin treatment to insulin degludec once daily, and mealtime NovoRapid®/NovoLog®. Insulin degludec treatment was optimised on a weekly basis to the pre-breakfast glycaemic target of 4.0-8.0 mmol/L. Out of 834 participants, who started the run-in period, 57 were run-in failures.

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 the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Period Title: Overall Study
STARTED	260	259	258
COMPLETED	256	251	253
NOT COMPLETED	4	8	5

Baseline Characteristics

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)	Total
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Total of all reporting groups
Overall Participants	260	259	258	777
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	11.72 (3.74)	11.62 (3.65)	11.70 (3.44)	11.68 (3.61)
Sex: Female, Male (Count of Participants)
Female	126 48.5%	122 47.1%	110 42.6%	358 46.1%
Male	134 51.5%	137 52.9%	148 57.4%	419 53.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 6.2%	17 6.6%	12 4.7%	45 5.8%
Not Hispanic or Latino	244 93.8%	242 93.4%	246 95.3%	732 94.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.4%	1 0.4%	2 0.3%
Asian	46 17.7%	37 14.3%	43 16.7%	126 16.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	6 2.3%	4 1.5%	5 1.9%	15 1.9%
White	206 79.2%	217 83.8%	209 81%	632 81.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	2 0.8%	0 0%	0 0%	2 0.3%

Outcome Measures

1. Primary Outcome

Title	Change in the Percentage of HbA1c
Description	Change from baseline (week 0) in glycosylated haemoglobin (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 participant-site contact and included data collected after a subject discontinued trial product.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS), which included all randomised participants. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	7.57 (0.80)	7.58 (0.84)	7.53 (0.83)
Change from baseline	0.06 (0.80)	0.33 (0.83)	0.23 (0.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Meal), NovoRapid (Meal)
	Comments	The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.
	Type of Statistical Test	Non-Inferiority
	Comments	Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.
	Method	Multiple imputation
	Comments	Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.30 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Post), NovoRapid (Meal)
	Comments	The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.
	Type of Statistical Test	Non-Inferiority
	Comments	Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. 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-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.
	Method	Multiple imputation
	Comments	Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Faster Aspart (Meal), NovoRapid (Meal)
	Comments	The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.
	Type of Statistical Test	Superiority
	Comments	Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.
Statistical Test of Hypothesis	p-Value	=0.007
	Comments	p-values are from the 1-sided test for superiority evaluated at the 2.5% level.
	Method	multiple imputation
	Comments	Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.30 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in 8-point SMPG Profile: Mean PPG Over All Three Meals
Description	Change from baseline (week 0) in mean post prandial glucose (PPG) over all three meals was evaluated after 26 weeks of randomisation. PPG for each meal (breakfast, lunch and main evening meal) was recorded by the participant as part of the 8-point self-measured plasma glucose (SMPG) profile. Mean PPG over all three meals was derived as the mean of all corresponding mean meal. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	10.19 (2.64)	10.12 (2.79)	10.03 (2.52)
Change from baseline	-0.94 (2.55)	0.36 (3.17)	-0.21 (2.79)

3. Secondary Outcome

Title	Change in 8-point SMPG Profile: PPG Increment Over All Three Meals
Description	Change from baseline (week 0) in mean PPG increment over all three meals was evaluated after 26 weeks of randomisation. Postprandial glucose (PPG) increment for each meal (breakfast, lunch and main evening meal) was derived from the 8-point profile as the difference between PPG (1 hour after the meal) values and the plasma glucose (PG) value before meal. The mean of the derived increments was then calculated separately for each meal. Mean PPG increment over all three meals was derived as the mean of all corresponding mean meal increments. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis. .

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	1.20 (2.70)	1.01 (2.48)	0.97 (2.55)
Change from baseline	-0.92 (2.92)	0.56 (2.88)	0.14 (2.75)

4. Secondary Outcome

Title	Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG
Description	Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG was evaluated after 26 weeks of randomisation. PPG for each meal was recorded by the participant as part of the 8-point SMPG profile. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Breakfast: Baseline	10.51 (3.59)	10.51 (3.77)	10.49 (3.59)
Breakfast: Change from baseline	-1.11 (3.91)	0.16 (3.95)	0.04 (3.89)
Lunch: Baseline	9.69 (3.32)	9.99 (3.82)	9.62 (3.30)
Lunch: Change from baseline	-0.80 (3.74)	0.18 (4.40)	-0.24 (4.22)
Main evening meal: Baseline	10.24 (3.64)	9.90 (3.59)	9.87 (3.46)
Main evening meal: Change from baseline	-0.74 (3.96)	0.61 (4.40)	-0.05 (4.14)

5. Secondary Outcome

Title	Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment
Description	Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG increment was evaluated after 26 weeks of randomisation. PPG increment for each meal was derived from the 8-point profile as the difference between PPG values (1 hour after the meal) and the PG value before meal. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Breakfast: Baseline	1.90 (3.64)	2.10 (3.59)	2.12 (4.08)
Breakfast: Change from baseline	-0.82 (4.44)	0.46 (4.21)	0.10 (4.66)
Lunch: Baseline	1.02 (3.82)	1.12 (3.79)	0.74 (3.88)
Lunch: Change from baseline	-0.58 (4.92)	0.12 (4.41)	-0.11 (4.54)
Main evening meal: Baseline	0.53 (4.28)	-0.26 (3.53)	-0.06 (3.78)
Main evening meal: Change from baseline	-0.92 (5.07)	1.03 (4.68)	0.45 (4.31)

6. Secondary Outcome

Title	Change in 8-point SMPG Profile: Mean of the 8-point Profile
Description	Change from baseline (week 0) in mean of the 8-point SMPG profile was evaluated after 26 weeks of randomisation. SMPG values were recorded at 8 time-points on two consecutive days: before and after (60 minute after the start of the meal) breakfast, lunch and main evening meal, before bedtime, and before breakfast on the next day. Mean of the 8-point profile was derived as the mean of all corresponding mean SMPG recorded at 8 different time points. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	9.41 (1.98)	9.47 (1.89)	9.39 (1.97)
Change from baseline	-0.27 (2.04)	0.17 (2.12)	-0.05 (2.29)

7. Secondary Outcome

Title	Fluctuation in the 8-point SMPG Profile
Description	Fluctuation in the 8-point SMPG profile was evaluated after 26 weeks of randomisation. Fluctuation in 8-point SMPG profile was the average absolute difference from the mean of the SMPG profile. The results are based on the last in-trial value.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Geometric Mean (Geometric Coefficient of Variation) [mmol/L]	1.88 (44.49)	1.94 (42.51)	1.83 (45.98)

8. Secondary Outcome

Title	Change in FPG
Description	Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	7.58 (3.56)	8.03 (3.35)	7.79 (3.48)
Change from baseline	0.41 (5.04)	-0.08 (4.49)	-0.13 (4.16)

9. Secondary Outcome

Title	Change in 1,5-anhydroglucitol
Description	Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	4.95 (3.62)	5.07 (3.97)	5.13 (3.76)
Change from baseline	-0.06 (3.13)	-0.85 (2.80)	-0.63 (2.42)

10. Secondary Outcome

Title	Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines
Description	Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Yes	42.3 16.3%	31.7 12.2%	39.5 15.3%
No	57.7 22.2%	68.3 26.4%	60.5 23.4%

11. Secondary Outcome

Title	Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia
Description	Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to ISPAD guidelines, without severe hypoglycaemia was evaluated after 26 weeks of randomisation. Severe hypoglycaemia according to ISPAD guidelines: hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose). The results are based on the last in-trial value.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Yes	41.9 16.1%	30.9 11.9%	38.4 14.9%
No	58.1 22.3%	69.1 26.7%	61.6 23.9%

12. Secondary Outcome

Title	Insulin Dose (Units/Day): Total Basal
Description	Total basal insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised NovoRapid®/NovoLog® / faster aspart and no later than 7 days after the day of last dose of NovoRapid®/NovoLog® / faster aspart. The on-treatment observation period includes data collected up to and including 7 days after treatment discontinuation. Number of participants analysed = number of participants contributed to the analysis. Analysis population description: Safety analysis set (SAS) included all participants receiving at least one dose of the investigational product (faster aspart) or its comparator (NovoRapid®/NovoLog®).
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Mean (Standard Deviation) [Units (U)]	21.6 (12.9)	21.5 (14.5)	20.7 (12.8)

13. Secondary Outcome

Title	Insulin Dose (Units/Day): Total Bolus
Description	Total bolus insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Mean (Standard Deviation) [Units (U)]	23.3 (14.5)	23.5 (15.1)	22.5 (13.0)

14. Secondary Outcome

Title	Insulin Dose (Units/Day): Individual Meal Insulin Dose
Description	Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Breakfast	7.3 (5.1)	7.1 (4.9)	6.8 (4.4)
Lunch	8.1 (5.1)	8.4 (6.2)	7.9 (5.2)
Main evening meal	8.1 (6.0)	8.0 (5.4)	7.7 (5.1)

15. Secondary Outcome

Title	Insulin Dose (Units/kg/Day): Total Basal
Description	Total basal insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Mean (Standard Deviation) [Units (U)/kg]	0.433 (0.228)	0.425 (0.196)	0.409 (0.176)

16. Secondary Outcome

Title	Insulin Dose (Units/kg/Day): Total Bolus
Description	Total bolus insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Mean (Standard Deviation) [Units (U)/kg]	0.483 (0.256)	0.491 (0.241)	0.468 (0.224)

17. Secondary Outcome

Title	Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose
Description	Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Breakfast	0.151 (0.091)	0.150 (0.079)	0.144 (0.081)
Lunch	0.170 (0.103)	0.174 (0.104)	0.166 (0.095)
Main evening meal	0.164 (0.099)	0.165 (0.092)	0.158 (0.086)

18. Secondary Outcome

Title	Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])
Description	Change from baseline (week 0) in the time spent in low IG (<=3.9 mmol/L [70 mg/dL]) based on continuous glucose monitoring (CGM) was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	107.94 (77.34)	100.70 (77.28)	81.52 (71.90)
Change from baseline	-24.11 (71.74)	-13.06 (82.55)	6.92 (74.64)

19. Secondary Outcome

Title	Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
Description	Incidence of episodes (number of episodes per 24 hours) with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was calculated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Episodes with IG <=2.5 mmol/L	0.55	0.68	0.57
Episodes with IG <=3.0 mmol/L	1.01	1.10	1.03
Episodes with IG <=3.9 mmol/L	2.29	2.30	2.24
Episodes with IG >10 mmol/L	11.52	11.61	11.65
Episodes with IG >12 mmol/L	7.64	7.77	8.05

20. Secondary Outcome

Title	Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
Description	Percentage of time spent with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Time spent with IG <=2.5 mmol/L	1.09 (1.50)	1.80 (3.21)	1.34 (1.90)
Time spent with IG <=3.0 mmol/L	2.19 (2.35)	2.90 (4.06)	2.48 (2.92)
Time spent with IG <=3.9 mmol/L	5.97 (4.59)	6.25 (5.68)	5.97 (5.38)
Time spent with IG >10 mmol/L	40.40 (14.80)	40.60 (14.38)	42.47 (17.51)
Time spent with IG >12 mmol/L	26.09 (12.82)	25.67 (13.60)	28.62 (16.83)

21. Secondary Outcome

Title	Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included
Description	Percentage of time spent within IG target 4.0-10.0 mmol/L (71-180 mg/dL), both included based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Mean (Standard Deviation) [Percentage of time]	53.00 (12.15)	52.56 (14.08)	51.03 (16.25)

22. Secondary Outcome

Title	Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)
Description	Change from baseline (week 0) in mean IG increment (0-1 hours and 0-2 hours after start of the meal) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
0-1 hour: Baseline	0.56 (0.58)	0.73 (0.54)	0.61 (0.49)
0-1 hour: Change from baseline	-0.19 (0.55)	0.26 (0.83)	0.07 (0.50)
0-2 hour: Baseline	0.76 (0.75)	1.10 (1.03)	0.86 (0.69)
0-2 hour: Change from baseline	-0.35 (0.87)	0.55 (1.14)	0.09 (0.59)

23. Secondary Outcome

Title	Change in Mean IG Peak After Start of Meal
Description	Change from baseline (week 0) in mean IG peak after start of meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	12.90 (1.88)	12.92 (1.97)	12.90 (2.25)
Change from baseline	-0.28 (1.91)	0.80 (1.84)	0.38 (2.00)

24. Secondary Outcome

Title	Change in Mean Time to the IG Peak After Meal
Description	Change from baseline (week 0) in mean time to the IG peak after meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of subjects wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	103.16 (16.87)	106.21 (20.68)	102.20 (17.09)
Change from baseline	4.70 (25.85)	-8.56 (22.62)	2.29 (19.80)

25. Secondary Outcome

Title	Change in 30-minute PPG
Description	Change from baseline (week 0) in 30-minute PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 30-minute after the meal intake at the visit. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	11.28 (3.26)	10.96 (3.78)	11.71 (3.13)
Change from baseline	-0.21 (3.49)	1.84 (3.41)	-0.45 (3.42)

26. Secondary Outcome

Title	Change in 30-minute PPG Increment
Description	Change from baseline (week 0) in 30-minute PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 30-minute (after the meal) at the visit. PPG increment was derived as 30-minute PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	3.44 (2.16)	3.48 (2.50)	4.02 (2.18)
Change from baseline	0.36 (2.92)	1.92 (2.79)	-0.34 (2.18)

27. Secondary Outcome

Title	Change in 1-hour PPG
Description	Change from baseline (week 0) in 1-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 1-hour after the meal intake at the visit. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	12.77 (3.92)	12.56 (5.08)	13.06 (3.86)
Change from baseline	-0.15 (4.39)	2.54 (4.43)	-0.63 (4.73)

28. Secondary Outcome

Title	Change in 1-hour PPG Increment
Description	Change from baseline (week 0) in 1-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 1-hour (after the meal) at the visit. PPG increment was derived as 1-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	4.93 (3.34)	5.08 (4.21)	5.36 (2.77)
Change from baseline	0.42 (4.93)	2.63 (4.03)	-0.52 (3.17)

29. Secondary Outcome

Title	Change in 2-hour PPG
Description	Change from baseline (week 0) in 2-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 2-hour after the meal intake at the visit. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	12.50 (4.63)	12.54 (5.74)	12.37 (4.74)
Change from baseline	0.69 (5.88)	1.80 (5.08)	-0.75 (5.64)

30. Secondary Outcome

Title	Change in 2-hour PPG Increment
Description	Change from baseline (week 0) in 2-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 2-hour (after the meal) at the visit. PPG increment was derived as 2-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	4.66 (4.22)	5.06 (5.04)	4.67 (3.83)
Change from baseline	1.26 (6.81)	1.62 (5.03)	-0.64 (4.43)

31. Secondary Outcome

Title	Change in AUCIG,0-15min
Description	Change in area under the IG curve 0-15 minutes post meal (AUCIG,0-15min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. Interstitial glucose (IG) was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	8.01 (2.72)	7.49 (2.07)	7.66 (1.96)
Change from baseline	-1.27 (3.68)	0.08 (2.48)	-0.53 (2.85)

32. Secondary Outcome

Title	Change in AUCIG,0-30min
Description	Change in area under the IG curve 0-30 minutes post meal (AUCIG,0-30min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	8.28 (2.75)	7.80 (2.13)	8.13 (1.87)
Change from baseline	-1.15 (3.62)	0.22 (2.52)	-0.47 (2.81)

33. Secondary Outcome

Title	Change in AUCIG,0-1h
Description	Change in area under the IG curve 0-1 hour post meal (AUCIG,0-1h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	9.63 (2.90)	9.43 (2.71)	10.02 (2.19)
Change from baseline	-0.87 (3.71)	0.54 (3.00)	-0.65 (2.91)

34. Secondary Outcome

Title	Change in AUCIG,0-2h
Description	Change in area under the IG curve 0-2 hours post meal (AUCIG,0-2h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	11.40 (3.20)	11.48 (3.43)	11.76 (2.80)
Change from baseline	-0.84 (3.93)	0.75 (3.74)	-0.86 (3.61)

35. Secondary Outcome

Title	Change in AUCIG,0-4h
Description	Change in area under the IG curve 0-4 hours post meal (AUCIG,0-4h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	11.21 (3.25)	11.19 (3.47)	11.46 (3.21)
Change from baseline	-0.38 (3.96)	0.62 (3.97)	-1.30 (4.13)

36. Secondary Outcome

Title	Change in Time to the IG Peak After Start of Meal
Description	Change in time to the IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	102.85 (48.93)	94.26 (38.22)	93.80 (39.19)
Change from baseline	5.29 (55.42)	-0.04 (42.05)	-8.76 (52.17)

37. Secondary Outcome

Title	Change in IG Peak After Start of Meal
Description	Change in IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	14.87 (3.55)	15.15 (4.52)	15.11 (3.62)
Change from baseline	-0.55 (3.77)	1.11 (4.88)	-1.36 (4.36)

38. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total
Description	Treatment emergent: if the onset of the episode occurred on or after the first day of treatment with investigational medicinal product (IMP) after randomisation, and no later than 1 day after the last day on IMP. Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic: episode during which typical symptoms of hypoglycaemia are accompanied by a PG level ≤3.9 mmol/L. 3) Asymptomatic: episode not accompanied by typical symptoms of hypoglycaemia, but with a PG level ≤3.9 mmol/L. 4) Probable symptomatic: an episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. 5) Pseudo-hypoglycaemia: episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a PG level >3.9mmol/L, but approaching that level. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	3	8	4
Documented symptomatic	5391	5712	5170
Asymptomatic	4255	3781	3656
Probable symptomatic	12	10	24
Pseudo-hypoglycaemia	35	37	47
Unclassifiable	5	2	1

39. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	3	5	3
Documented symptomatic	4895	5077	4779
Asymptomatic	3584	3163	3101
Probable symptomatic	10	10	22
Pseudo-hypoglycaemia	32	31	42
Unclassifiable	5	2	1

40. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	0	3	1
Documented symptomatic	496	635	391
Asymptomatic	671	618	555
Probable symptomatic	2	0	2
Pseudo-hypoglycaemia	3	6	5
Unclassifiable	0	0	0

41. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) Symptomatic blood glucose (BG) confirmed: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3) Asymptomatic BG confirmed: episode that is BG confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG confirmed symptomatic: an episode that is severe according to the ISPAD classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG confirmed: an episode that is BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG confirmed: an episode that is severe according to the ISPAD Classification or BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	3	8	4
BG confirmed	3580	3586	3272
Severe or BG confirmed symptomatic	2242	2427	2194
Severe or BG confirmed	3583	3594	3276
Unclassifiable	6118	5956	5626

42. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	3	5	3
BG confirmed	3184	3112	2960
Severe or BG confirmed symptomatic	2062	2167	2035
Severe or BG confirmed	3187	3117	2963
Unclassifiable	5342	5171	4985

43. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	0	3	1
BG confirmed	396	474	312
Severe or BG confirmed symptomatic	180	260	159
Severe or BG confirmed	396	477	313
Unclassifiable	776	785	641

44. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	0	0	0
Documented symptomatic	178	113	157
Asymptomatic	77	51	55
Probable symptomatic	0	0	1
Pseudo-hypoglycaemia	1	2	1
Unclassifiable	0	0	0

45. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	2	1	1
Documented symptomatic	1125	882	1016
Asymptomatic	421	268	303
Probable symptomatic	1	1	7
Pseudo-hypoglycaemia	6	6	4
Unclassifiable	0	0	0

46. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	3	1	2
Documented symptomatic	3041	3064	2812
Asymptomatic	1340	1194	1168
Probable symptomatic	4	8	16
Pseudo-hypoglycaemia	15	18	17
Unclassifiable	2	0	0

47. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	1	0	1
Documented symptomatic	1916	2182	1796
Asymptomatic	919	926	865
Probable symptomatic	3	7	9
Pseudo-hypoglycaemia	9	12	13
Unclassifiable	2	0	0

48. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	0	0	0
BG confirmed	119	66	105
Severe or BG confirmed symptomatic	94	49	85
Severe or BG confirmed	119	66	105
Unclassifiable	137	100	109

49. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	2	1	1
BG confirmed	715	504	600
Severe or BG confirmed symptomatic	572	414	495
Severe or BG confirmed	717	505	601
Unclassifiable	838	653	730

50. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	3	1	2
BG confirmed	1774	1781	1666
Severe or BG confirmed symptomatic	1365	1375	1277
Severe or BG confirmed	1777	1782	1668
Unclassifiable	2628	2503	2347

51. Secondary Outcome

Title	Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Description	Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Severe	1	0	1
BG confirmed	1059	1277	1066
Severe or BG confirmed symptomatic	793	961	782
Severe or BG confirmed	1060	1277	1067
Unclassifiable	1790	1850	1617

52. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events (AEs)
Description	Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP (faster aspart or NovoRapid®/NovoLog®) and excluding the events occurring in the run-in period. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Number [Events]	576	678	593

53. Secondary Outcome

Title	Number of Treatment Emergent Injection Site Reactions
Description	Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP and excluding the events occurring in the run-in period. The results are based on the on-treatment period.
Time Frame	Week 0-26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Number [Events]	11	31	17

54. Secondary Outcome

Title	Change in Physical Examination
Description	The following physical examinations were done: 1) Cardiovascular system. 2) Central and peripheral nervous system. 3) Gastrointestinal system including the mouth. 4) General appearance. 5) Head, ears, eyes, nose, throat and neck. 6) Musculoskeletal system. 7) Respiratory system. 8) Skin. Presented results are number of participants with the following outcomes: normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Presented results are baseline (week 0) and last on-treatment values. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
1) Baseline: Normal	260 100%	254 98.1%	258 100%
1) Baseline: Abnormal, NCS	1 0.4%	4 1.5%	0 0%
1) Baseline: Abnormal, CS	0 0%	0 0%	0 0%
1) Last on-treatment: Normal	257 98.8%	253 97.7%	257 99.6%
1) Last on-treatment: Abnormal, NCS	0 0%	5 1.9%	0 0%
1) Last on-treatment: Abnormal, CS	0 0%	0 0%	0 0%
2) Baseline: Normal	257 98.8%	253 97.7%	258 100%
2) Baseline: Abnormal, NCS	3 1.2%	4 1.5%	0 0%
2) Baseline: Abnormal, CS	1 0.4%	1 0.4%	0 0%
2) Last on-treatment: Normal	255 98.1%	253 97.7%	257 99.6%
2) Last on-treatment: Abnormal, NCS	2 0.8%	4 1.5%	0 0%
2) Last on-treatment: Abnormal, CS	0 0%	1 0.4%	0 0%
3) Baseline: Normal	258 99.2%	257 99.2%	254 98.4%
3) Baseline: Abnormal, NCS	3 1.2%	1 0.4%	3 1.2%
3) Baseline: Abnormal, CS	0 0%	0 0%	1 0.4%
3) Last on-treatment: Normal	253 97.3%	257 99.2%	256 99.2%
3) Last on-treatment: Abnormal, NCS	4 1.5%	1 0.4%	0 0%
3) Last on-treatment: Abnormal, CS	0 0%	0 0%	1 0.4%
4) Baseline: Normal	258 99.2%	253 97.7%	254 98.4%
4) Baseline: Abnormal, NCS	2 0.8%	3 1.2%	4 1.6%
4) Baseline: Abnormal, CS	1 0.4%	2 0.8%	0 0%
4) Last on-treatment: Normal	257 98.8%	253 97.7%	254 98.4%
4) Last on-treatment: Abnormal, NCS	0 0%	4 1.5%	3 1.2%
4) Last on-treatment: Abnormal, CS	0 0%	1 0.4%	0 0%
5) Baseline: Normal	251 96.5%	238 91.9%	245 95%
5) Baseline: Abnormal, NCS	9 3.5%	13 5%	11 4.3%
5) Baseline: Abnormal, CS	1 0.4%	7 2.7%	2 0.8%
5) Last on-treatment: Normal	247 95%	244 94.2%	242 93.8%
5) Last on-treatment: Abnormal, NCS	7 2.7%	11 4.2%	14 5.4%
5) Last on-treatment: Abnormal, CS	3 1.2%	3 1.2%	1 0.4%
6) Baseline: Normal	259 99.6%	252 97.3%	254 98.4%
6) Baseline: Abnormal, NCS	2 0.8%	4 1.5%	3 1.2%
6) Baseline: Abnormal, CS	0 0%	2 0.8%	1 0.4%
6) Last on-treatment: Normal	254 97.7%	253 97.7%	253 98.1%
6) Last on-treatment: Abnormal, NCS	1 0.4%	3 1.2%	3 1.2%
6) Last on-treatment: Abnormal, CS	2 0.8%	2 0.8%	1 0.4%
7) Baseline: Normal	259 99.6%	256 98.8%	256 99.2%
7) Baseline: Abnormal, NCS	1 0.4%	2 0.8%	1 0.4%
7) Baseline: Abnormal, CS	1 0.4%	0 0%	1 0.4%
7) Last on-treatment: Normal	257 98.8%	258 99.6%	257 99.6%
7) Last on-treatment: Abnormal, NCS	0 0%	0 0%	0 0%
7) Last on-treatment: Abnormal, CS	0 0%	0 0%	0 0%
8) Baseline: Normal	239 91.9%	237 91.5%	238 92.2%
8) Baseline: Abnormal, NCS	18 6.9%	21 8.1%	16 6.2%
8) Baseline: Abnormal, CS	4 1.5%	0 0%	4 1.6%
8) Last on-treatment: Normal	229 88.1%	233 90%	235 91.1%
8) Last on-treatment: Abnormal, NCS	19 7.3%	22 8.5%	17 6.6%
8) Last on-treatment: Abnormal, CS	9 3.5%	3 1.2%	5 1.9%

55. Secondary Outcome

Title	Change in Vital Sign: Blood Pressure
Description	Change from baseline (week 0) in blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
SBP: Baseline	106.4 (11.8)	107.0 (12.6)	106.8 (11.4)
SBP: Change from baseline	0.8 (11.0)	1.5 (10.4)	1.1 (10.1)
DBP: Baseline	65.4 (8.3)	65.7 (9.4)	65.4 (7.9)
DBP: Change from baseline	1.2 (9.1)	1.4 (9.3)	1.4 (8.3)

56. Secondary Outcome

Title	Change in Vital Sign: Pulse
Description	Change from baseline (week 0) in pulse was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	80.6 (11.8)	80.5 (11.8)	79.4 (11.8)
Change from baseline	-0.6 (10.3)	0.3 (10.8)	0.7 (11.0)

57. Secondary Outcome

Title	Change in Body Weight
Description	Change from baseline (week 0) in body weight was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	46.69 (18.15)	46.48 (18.98)	46.28 (17.18)
Change from baseline	2.21 (2.57)	1.90 (2.32)	2.15 (2.80)

58. Secondary Outcome

Title	Change in Height
Description	Change from baseline (week 0) in height was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	1.50 (0.21)	1.50 (0.21)	1.50 (0.19)
Change from baseline	0.02 (0.02)	0.02 (0.02)	0.02 (0.02)

59. Secondary Outcome

Title	Change in Body Mass Index
Description	Change from baseline (week 0) in body mass index (BMI) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	19.68 (3.75)	19.67 (4.02)	19.64 (3.78)
Change from baseline	0.37 (0.92)	0.28 (0.92)	0.34 (1.10)

60. Secondary Outcome

Title	Change in SD Score of Body Weight
Description	Change from baseline (week 0) in standard deviation (SD) score of body weight was evaluated after 26 weeks of randomisation. SD-scores are defined to be able to normalise the body weight in the various age groups. To estimate the growth of children, standardised weight is calculated for each year of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. The SD scores are derived from the age and sex of the subjects and the body weight together with growth curves defined for a reference population. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	0.349 (0.945)	0.351 (0.936)	0.361 (0.875)
Change from baseline	0.034 (0.231)	0.008 (0.223)	0.030 (0.250)

61. Secondary Outcome

Title	Change in SD Score of Body Mass Index
Description	Change from baseline (week 0) in SD score of BMI was evaluated after 26 weeks of randomisation. SD scores for BMI were determined in a similar way as SD scores for weight by use of a suitable reference population based on age and sex. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	0.296 (0.895)	0.298 (0.936)	0.317 (0.898)
Change from baseline	0.016 (0.308)	0.004 (0.370)	0.007 (0.338)

62. Secondary Outcome

Title	Change in Haematology: Haemoglobin
Description	Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	8.33 (0.72)	8.47 (0.74)	8.41 (0.77)
Change from baseline	0.08 (0.51)	0.09 (0.62)	0.09 (0.52)

63. Secondary Outcome

Title	Change in Haematology: Haematocrit
Description	Change from baseline (week 0) in haematocrit was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	40.87 (3.39)	41.51 (3.50)	41.34 (3.75)
Change from baseline	0.45 (2.86)	0.40 (3.09)	0.32 (2.75)

64. Secondary Outcome

Title	Change in Haematology: Erythrocytes
Description	Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	4.81 (0.39)	4.87 (0.39)	4.88 (0.40)
Change from baseline	0.02 (0.27)	0.04 (0.31)	0.02 (0.26)

65. Secondary Outcome

Title	Change in Haematology: Thrombocytes
Description	Change from baseline (week 0) in thrombocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	268.1 (64.5)	270.0 (60.2)	262.5 (57.9)
Change from baseline	1.2 (47.3)	1.6 (45.4)	6.0 (44.9)

66. Secondary Outcome

Title	Change in Haematology: Leukocytes
Description	Change from baseline (week 0) in leukocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	6.10 (1.65)	6.10 (1.63)	6.11 (1.81)
Change from baseline	0.08 (1.66)	0.14 (1.74)	0.10 (1.67)

67. Secondary Outcome

Title	Change in Biochemistry: Creatinine
Description	Change from baseline (week 0) in creatinine was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	51.8 (14.2)	52.6 (13.3)	52.1 (12.3)
Change from baseline	1.1 (7.8)	1.5 (6.9)	1.7 (6.8)

68. Secondary Outcome

Title	Change in Biochemistry: Alanine Aminotransferase (ALT)
Description	Change from baseline (week 0) in ALT was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	14.4 (6.4)	14.7 (7.4)	14.8 (5.6)
Change from baseline	0.1 (6.9)	1.3 (14.9)	0.5 (5.9)

69. Secondary Outcome

Title	Change in Biochemistry: Aspartate Aminotransferase (AST)
Description	Change from baseline (week 0) in AST was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	19.9 (6.8)	20.0 (5.6)	20.5 (5.9)
Change from baseline	0.1 (6.2)	1.1 (11.7)	-0.4 (5.0)

70. Secondary Outcome

Title	Change in Biochemistry: Alkaline Phosphatase (AP)
Description	Change from baseline (week 0) in AP was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	212.7 (135.8)	209.8 (94.9)	226.2 (93.6)
Change from baseline	-3.0 (119.0)	-1.7 (50.8)	-2.8 (80.4)

71. Secondary Outcome

Title	Change in Biochemistry: Sodium
Description	Change from baseline (week 0) in sodium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	139.5 (2.5)	139.6 (2.4)	139.7 (2.5)
Change from baseline	0.5 (2.8)	0.3 (2.7)	0.04 (2.8)

72. Secondary Outcome

Title	Change in Biochemistry: Potassium
Description	Change from baseline (week 0) in potassium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	4.48 (0.34)	4.52 (0.34)	4.52 (0.40)
Change from baseline	0.02 (0.41)	-0.06 (0.34)	0.01 (0.50)

73. Secondary Outcome

Title	Change in Biochemistry: Albumin
Description	Change from baseline (week 0) in albumin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	4.47 (0.24)	4.51 (0.24)	4.50 (0.25)
Change from baseline	0.01 (0.24)	0.01 (0.25)	0.005 (0.24)

74. Secondary Outcome

Title	Change in Biochemistry: Total Bilirubin
Description	Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	7.9 (6.0)	7.9 (5.3)	8.0 (6.2)
Change from baseline	0.2 (4.9)	0.2 (3.4)	0.3 (4.1)

75. Secondary Outcome

Title	Change in Lipid Profile: Total Cholesterol
Description	Change from baseline (week 0) in total cholesterol after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Geometric Mean (Geometric Coefficient of Variation) [Ratio]	0.989 (13.869)	1.023 (13.742)	1.016 (13.187)

76. Secondary Outcome

Title	Change in Lipid Profile: High Density Lipoproteins (HDL)
Description	Change from baseline (week 0) in HDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Geometric Mean (Geometric Coefficient of Variation) [Ratio]	1.004 (17.865)	1.030 (20.180)	1.023 (17.852)

77. Secondary Outcome

Title	Change in Lipid Profile: Low Density Lipoproteins (LDL)
Description	Change from baseline (week 0) in LDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

FAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Geometric Mean (Geometric Coefficient of Variation) [Ratio]	1.014 (19.533)	1.040 (19.685)	1.041 (19.864)

78. Secondary Outcome

Title	Change in Anti-insulin Aspart Antibody Development: Specific
Description	Change from baseline (week 0) in 'antibodies specific for insulin aspart' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	1.436 (3.159)	1.459 (5.313)	1.183 (2.134)
Change from baseline	-0.099 (1.015)	-0.213 (1.661)	-0.201 (1.238)

79. Secondary Outcome

Title	Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin
Description	Change from baseline (week 0) in 'antibodies for insulin aspart, those cross-reacting with human insulin' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	18.794 (17.189)	21.576 (17.721)	20.156 (17.315)
Change from baseline	-3.202 (6.989)	-4.845 (7.034)	-3.802 (7.587)

80. Secondary Outcome

Title	Change in Anti-insulin Aspart Antibody Development: Total
Description	Change from baseline (week 0) in 'total anti-insulin aspart antibodies (specific for insulin aspart and those cross-reacting with human insulin)' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.

Arm/Group Title	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.	Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Measure Participants	260	259	258
Baseline	20.230 (17.795)	23.044 (18.070)	21.344 (17.825)
Change from baseline	-3.271 (7.158)	-5.061 (7.193)	-4.004 (7.700)

Adverse Events

Time Frame	Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent.
Adverse Event Reporting Description	SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title	Faster Aspart (Meal)		Faster Aspart (Post)		NovoRapid (Meal)
Arm/Group Description	Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.		Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 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 premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.		Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 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 pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
All Cause Mortality
	Faster Aspart (Meal)		Faster Aspart (Post)		NovoRapid (Meal)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/261 (0%)		0/258 (0%)		0/258 (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	5/261 (1.9%)		13/258 (5%)		9/258 (3.5%)
Cardiac disorders
Palpitations	0/261 (0%)	0	1/258 (0.4%)	1	0/258 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/261 (0%)	0	0/258 (0%)	0	1/258 (0.4%)	1
Gastritis	0/261 (0%)	0	0/258 (0%)	0	1/258 (0.4%)	2
Infections and infestations
Appendicitis	2/261 (0.8%)	2	0/258 (0%)	0	0/258 (0%)	0
Gastroenteritis	0/261 (0%)	0	0/258 (0%)	0	3/258 (1.2%)	3
Gastrointestinal viral infection	1/261 (0.4%)	1	0/258 (0%)	0	0/258 (0%)	0
Influenza	0/261 (0%)	0	1/258 (0.4%)	1	0/258 (0%)	0
Osteomyelitis	0/261 (0%)	0	0/258 (0%)	0	1/258 (0.4%)	1
Pneumonia	1/261 (0.4%)	1	0/258 (0%)	0	0/258 (0%)	0
Tonsillitis	0/261 (0%)	0	0/258 (0%)	0	1/258 (0.4%)	1
Injury, poisoning and procedural complications
Accidental overdose	1/261 (0.4%)	1	2/258 (0.8%)	2	0/258 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/261 (0%)	0	0/258 (0%)	0	1/258 (0.4%)	1
Diabetic ketoacidosis	0/261 (0%)	0	2/258 (0.8%)	2	2/258 (0.8%)	2
Hyperglycaemia	0/261 (0%)	0	0/258 (0%)	0	1/258 (0.4%)	1
Hypoglycaemia	1/261 (0.4%)	1	2/258 (0.8%)	2	1/258 (0.4%)	1
Musculoskeletal and connective tissue disorders
Epiphysiolysis	0/261 (0%)	0	1/258 (0.4%)	1	0/258 (0%)	0
Nervous system disorders
Hypoglycaemic unconsciousness	0/261 (0%)	0	2/258 (0.8%)	2	0/258 (0%)	0
Idiopathic partial epilepsy	1/261 (0.4%)	1	0/258 (0%)	0	0/258 (0%)	0
Psychiatric disorders
Adjustment disorder with mixed disturbance of emotion and conduct	0/261 (0%)	0	1/258 (0.4%)	1	0/258 (0%)	0
Renal and urinary disorders
Nephrotic syndrome	0/261 (0%)	0	1/258 (0.4%)	1	0/258 (0%)	0
Renal colic	0/261 (0%)	0	1/258 (0.4%)	1	0/258 (0%)	0
Surgical and medical procedures
Diabetes mellitus management	0/261 (0%)	0	1/258 (0.4%)	1	0/258 (0%)	0
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	137/261 (52.5%)		149/258 (57.8%)		136/258 (52.7%)
Gastrointestinal disorders
Vomiting	9/261 (3.4%)	9	21/258 (8.1%)	24	7/258 (2.7%)	7
General disorders
Pyrexia	22/261 (8.4%)	26	16/258 (6.2%)	16	18/258 (7%)	20
Infections and infestations
Gastroenteritis	13/261 (5%)	15	16/258 (6.2%)	17	19/258 (7.4%)	24
Influenza	20/261 (7.7%)	28	14/258 (5.4%)	19	14/258 (5.4%)	21
Rhinitis	10/261 (3.8%)	16	16/258 (6.2%)	24	11/258 (4.3%)	16
Upper respiratory tract infection	22/261 (8.4%)	31	32/258 (12.4%)	41	26/258 (10.1%)	32
Viral infection	7/261 (2.7%)	8	9/258 (3.5%)	11	14/258 (5.4%)	20
Viral upper respiratory tract infection	60/261 (23%)	73	53/258 (20.5%)	79	48/258 (18.6%)	75
Nervous system disorders
Headache	16/261 (6.1%)	21	26/258 (10.1%)	38	22/258 (8.5%)	35
Respiratory, thoracic and mediastinal disorders
Cough	10/261 (3.8%)	11	11/258 (4.3%)	14	16/258 (6.2%)	21
Oropharyngeal pain	10/261 (3.8%)	12	9/258 (3.5%)	13	13/258 (5%)	16

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