Trial Outcomes & Findings for 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 (NCT NCT02670915)

NCT ID: NCT02670915

Last Updated: 2019-06-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 834 participants
• Primary outcome timeframe: Week 0, Week 26
• Results posted on: 2019-06-05

Participant Flow

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

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.

Participant milestones

Measure	Faster Aspart (Meal) 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.	Faster Aspart (Post) 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.	NovoRapid (Meal) 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.
Overall Study STARTED	260	259	258
Overall Study COMPLETED	256	251	253
Overall Study NOT COMPLETED	4	8	5

Reasons for withdrawal

Measure	Faster Aspart (Meal) 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.	Faster Aspart (Post) 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.	NovoRapid (Meal) 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.
Overall Study Withdrawal by Subject	0	1	4
Overall Study Withdrawal by parent/guardian	4	4	1
Overall Study Unclassified	0	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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 n=777 Participants Total of all reporting groups
Age, Continuous	11.72 Years STANDARD_DEVIATION 3.74 • n=5 Participants	11.62 Years STANDARD_DEVIATION 3.65 • n=7 Participants	11.70 Years STANDARD_DEVIATION 3.44 • n=5 Participants	11.68 Years STANDARD_DEVIATION 3.61 • n=4 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	122 Participants n=7 Participants	110 Participants n=5 Participants	358 Participants n=4 Participants
Sex: Female, Male Male	134 Participants n=5 Participants	137 Participants n=7 Participants	148 Participants n=5 Participants	419 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	17 Participants n=7 Participants	12 Participants n=5 Participants	45 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	244 Participants n=5 Participants	242 Participants n=7 Participants	246 Participants n=5 Participants	732 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	46 Participants n=5 Participants	37 Participants n=7 Participants	43 Participants n=5 Participants	126 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	206 Participants n=5 Participants	217 Participants n=7 Participants	209 Participants n=5 Participants	632 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in the Percentage of HbA1c Baseline	7.57 Percentage of HbA1c Standard Deviation 0.80	7.58 Percentage of HbA1c Standard Deviation 0.84	7.53 Percentage of HbA1c Standard Deviation 0.83
Change in the Percentage of HbA1c Change from baseline	0.06 Percentage of HbA1c Standard Deviation 0.80	0.33 Percentage of HbA1c Standard Deviation 0.83	0.23 Percentage of HbA1c Standard Deviation 0.82

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 8-point SMPG Profile: Mean PPG Over All Three Meals Baseline	10.19 mmol/L Standard Deviation 2.64	10.12 mmol/L Standard Deviation 2.79	10.03 mmol/L Standard Deviation 2.52
Change in 8-point SMPG Profile: Mean PPG Over All Three Meals Change from baseline	-0.94 mmol/L Standard Deviation 2.55	0.36 mmol/L Standard Deviation 3.17	-0.21 mmol/L Standard Deviation 2.79

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 8-point SMPG Profile: PPG Increment Over All Three Meals Baseline	1.20 mmol/L Standard Deviation 2.70	1.01 mmol/L Standard Deviation 2.48	0.97 mmol/L Standard Deviation 2.55
Change in 8-point SMPG Profile: PPG Increment Over All Three Meals Change from baseline	-0.92 mmol/L Standard Deviation 2.92	0.56 mmol/L Standard Deviation 2.88	0.14 mmol/L Standard Deviation 2.75

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Breakfast: Baseline	10.51 mmol/L Standard Deviation 3.59	10.51 mmol/L Standard Deviation 3.77	10.49 mmol/L Standard Deviation 3.59
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Breakfast: Change from baseline	-1.11 mmol/L Standard Deviation 3.91	0.16 mmol/L Standard Deviation 3.95	0.04 mmol/L Standard Deviation 3.89
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Lunch: Baseline	9.69 mmol/L Standard Deviation 3.32	9.99 mmol/L Standard Deviation 3.82	9.62 mmol/L Standard Deviation 3.30
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Lunch: Change from baseline	-0.80 mmol/L Standard Deviation 3.74	0.18 mmol/L Standard Deviation 4.40	-0.24 mmol/L Standard Deviation 4.22
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Main evening meal: Baseline	10.24 mmol/L Standard Deviation 3.64	9.90 mmol/L Standard Deviation 3.59	9.87 mmol/L Standard Deviation 3.46
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Main evening meal: Change from baseline	-0.74 mmol/L Standard Deviation 3.96	0.61 mmol/L Standard Deviation 4.40	-0.05 mmol/L Standard Deviation 4.14

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment Breakfast: Baseline	1.90 mmol/L Standard Deviation 3.64	2.10 mmol/L Standard Deviation 3.59	2.12 mmol/L Standard Deviation 4.08
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment Breakfast: Change from baseline	-0.82 mmol/L Standard Deviation 4.44	0.46 mmol/L Standard Deviation 4.21	0.10 mmol/L Standard Deviation 4.66
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment Lunch: Baseline	1.02 mmol/L Standard Deviation 3.82	1.12 mmol/L Standard Deviation 3.79	0.74 mmol/L Standard Deviation 3.88
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment Lunch: Change from baseline	-0.58 mmol/L Standard Deviation 4.92	0.12 mmol/L Standard Deviation 4.41	-0.11 mmol/L Standard Deviation 4.54
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment Main evening meal: Baseline	0.53 mmol/L Standard Deviation 4.28	-0.26 mmol/L Standard Deviation 3.53	-0.06 mmol/L Standard Deviation 3.78
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment Main evening meal: Change from baseline	-0.92 mmol/L Standard Deviation 5.07	1.03 mmol/L Standard Deviation 4.68	0.45 mmol/L Standard Deviation 4.31

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 8-point SMPG Profile: Mean of the 8-point Profile Baseline	9.41 mmol/L Standard Deviation 1.98	9.47 mmol/L Standard Deviation 1.89	9.39 mmol/L Standard Deviation 1.97
Change in 8-point SMPG Profile: Mean of the 8-point Profile Change from baseline	-0.27 mmol/L Standard Deviation 2.04	0.17 mmol/L Standard Deviation 2.12	-0.05 mmol/L Standard Deviation 2.29

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Fluctuation in the 8-point SMPG Profile	1.88 mmol/L Geometric Coefficient of Variation 44.49	1.94 mmol/L Geometric Coefficient of Variation 42.51	1.83 mmol/L Geometric Coefficient of Variation 45.98

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in FPG Baseline	7.58 mmol/L Standard Deviation 3.56	8.03 mmol/L Standard Deviation 3.35	7.79 mmol/L Standard Deviation 3.48
Change in FPG Change from baseline	0.41 mmol/L Standard Deviation 5.04	-0.08 mmol/L Standard Deviation 4.49	-0.13 mmol/L Standard Deviation 4.16

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 1,5-anhydroglucitol Change from baseline	-0.06 ug/mL Standard Deviation 3.13	-0.85 ug/mL Standard Deviation 2.80	-0.63 ug/mL Standard Deviation 2.42
Change in 1,5-anhydroglucitol Baseline	4.95 ug/mL Standard Deviation 3.62	5.07 ug/mL Standard Deviation 3.97	5.13 ug/mL Standard Deviation 3.76

SECONDARY outcome

Timeframe: Week 26

Population: FAS.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines Yes	42.3 Percentage of participants	31.7 Percentage of participants	39.5 Percentage of participants
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines No	57.7 Percentage of participants	68.3 Percentage of participants	60.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia Yes	41.9 Percentage of participants	30.9 Percentage of participants	38.4 Percentage of participants
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia No	58.1 Percentage of participants	69.1 Percentage of participants	61.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: 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.

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®).

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Insulin Dose (Units/Day): Total Basal	21.6 Units (U) Standard Deviation 12.9	21.5 Units (U) Standard Deviation 14.5	20.7 Units (U) Standard Deviation 12.8

SECONDARY outcome

Timeframe: Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Insulin Dose (Units/Day): Total Bolus	23.3 Units (U) Standard Deviation 14.5	23.5 Units (U) Standard Deviation 15.1	22.5 Units (U) Standard Deviation 13.0

SECONDARY outcome

Timeframe: Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Insulin Dose (Units/Day): Individual Meal Insulin Dose Breakfast	7.3 Units (U) Standard Deviation 5.1	7.1 Units (U) Standard Deviation 4.9	6.8 Units (U) Standard Deviation 4.4
Insulin Dose (Units/Day): Individual Meal Insulin Dose Lunch	8.1 Units (U) Standard Deviation 5.1	8.4 Units (U) Standard Deviation 6.2	7.9 Units (U) Standard Deviation 5.2
Insulin Dose (Units/Day): Individual Meal Insulin Dose Main evening meal	8.1 Units (U) Standard Deviation 6.0	8.0 Units (U) Standard Deviation 5.4	7.7 Units (U) Standard Deviation 5.1

SECONDARY outcome

Timeframe: Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Insulin Dose (Units/kg/Day): Total Basal	0.433 Units (U)/kg Standard Deviation 0.228	0.425 Units (U)/kg Standard Deviation 0.196	0.409 Units (U)/kg Standard Deviation 0.176

SECONDARY outcome

Timeframe: Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Insulin Dose (Units/kg/Day): Total Bolus	0.483 Units (U)/kg Standard Deviation 0.256	0.491 Units (U)/kg Standard Deviation 0.241	0.468 Units (U)/kg Standard Deviation 0.224

SECONDARY outcome

Timeframe: Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose Breakfast	0.151 Units (U)/kg Standard Deviation 0.091	0.150 Units (U)/kg Standard Deviation 0.079	0.144 Units (U)/kg Standard Deviation 0.081
Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose Lunch	0.170 Units (U)/kg Standard Deviation 0.103	0.174 Units (U)/kg Standard Deviation 0.104	0.166 Units (U)/kg Standard Deviation 0.095
Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose Main evening meal	0.164 Units (U)/kg Standard Deviation 0.099	0.165 Units (U)/kg Standard Deviation 0.092	0.158 Units (U)/kg Standard Deviation 0.086

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) Baseline	107.94 Minutes/day Standard Deviation 77.34	100.70 Minutes/day Standard Deviation 77.28	81.52 Minutes/day Standard Deviation 71.90
Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) Change from baseline	-24.11 Minutes/day Standard Deviation 71.74	-13.06 Minutes/day Standard Deviation 82.55	6.92 Minutes/day Standard Deviation 74.64

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
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) Episodes with IG <=2.5 mmol/L	0.55 Episodes per 24 hours	0.68 Episodes per 24 hours	0.57 Episodes per 24 hours
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) Episodes with IG <=3.0 mmol/L	1.01 Episodes per 24 hours	1.10 Episodes per 24 hours	1.03 Episodes per 24 hours
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) Episodes with IG <=3.9 mmol/L	2.29 Episodes per 24 hours	2.30 Episodes per 24 hours	2.24 Episodes per 24 hours
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) Episodes with IG >10 mmol/L	11.52 Episodes per 24 hours	11.61 Episodes per 24 hours	11.65 Episodes per 24 hours
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) Episodes with IG >12 mmol/L	7.64 Episodes per 24 hours	7.77 Episodes per 24 hours	8.05 Episodes per 24 hours

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
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) Time spent with IG <=2.5 mmol/L	1.09 Percentage of time Standard Deviation 1.50	1.80 Percentage of time Standard Deviation 3.21	1.34 Percentage of time Standard Deviation 1.90
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) Time spent with IG <=3.0 mmol/L	2.19 Percentage of time Standard Deviation 2.35	2.90 Percentage of time Standard Deviation 4.06	2.48 Percentage of time Standard Deviation 2.92
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) Time spent with IG <=3.9 mmol/L	5.97 Percentage of time Standard Deviation 4.59	6.25 Percentage of time Standard Deviation 5.68	5.97 Percentage of time Standard Deviation 5.38
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) Time spent with IG >10 mmol/L	40.40 Percentage of time Standard Deviation 14.80	40.60 Percentage of time Standard Deviation 14.38	42.47 Percentage of time Standard Deviation 17.51
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) Time spent with IG >12 mmol/L	26.09 Percentage of time Standard Deviation 12.82	25.67 Percentage of time Standard Deviation 13.60	28.62 Percentage of time Standard Deviation 16.83

SECONDARY outcome

Timeframe: Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included	53.00 Percentage of time Standard Deviation 12.15	52.56 Percentage of time Standard Deviation 14.08	51.03 Percentage of time Standard Deviation 16.25

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) 0-1 hour: Baseline	0.56 mmol/L Standard Deviation 0.58	0.73 mmol/L Standard Deviation 0.54	0.61 mmol/L Standard Deviation 0.49
Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) 0-1 hour: Change from baseline	-0.19 mmol/L Standard Deviation 0.55	0.26 mmol/L Standard Deviation 0.83	0.07 mmol/L Standard Deviation 0.50
Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) 0-2 hour: Baseline	0.76 mmol/L Standard Deviation 0.75	1.10 mmol/L Standard Deviation 1.03	0.86 mmol/L Standard Deviation 0.69
Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) 0-2 hour: Change from baseline	-0.35 mmol/L Standard Deviation 0.87	0.55 mmol/L Standard Deviation 1.14	0.09 mmol/L Standard Deviation 0.59

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Mean IG Peak After Start of Meal Baseline	12.90 mmol/L Standard Deviation 1.88	12.92 mmol/L Standard Deviation 1.97	12.90 mmol/L Standard Deviation 2.25
Change in Mean IG Peak After Start of Meal Change from baseline	-0.28 mmol/L Standard Deviation 1.91	0.80 mmol/L Standard Deviation 1.84	0.38 mmol/L Standard Deviation 2.00

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Mean Time to the IG Peak After Meal Baseline	103.16 Minutes Standard Deviation 16.87	106.21 Minutes Standard Deviation 20.68	102.20 Minutes Standard Deviation 17.09
Change in Mean Time to the IG Peak After Meal Change from baseline	4.70 Minutes Standard Deviation 25.85	-8.56 Minutes Standard Deviation 22.62	2.29 Minutes Standard Deviation 19.80

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 30-minute PPG Baseline	11.28 mmol/L Standard Deviation 3.26	10.96 mmol/L Standard Deviation 3.78	11.71 mmol/L Standard Deviation 3.13
Change in 30-minute PPG Change from baseline	-0.21 mmol/L Standard Deviation 3.49	1.84 mmol/L Standard Deviation 3.41	-0.45 mmol/L Standard Deviation 3.42

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 30-minute PPG Increment Baseline	3.44 mmol/L Standard Deviation 2.16	3.48 mmol/L Standard Deviation 2.50	4.02 mmol/L Standard Deviation 2.18
Change in 30-minute PPG Increment Change from baseline	0.36 mmol/L Standard Deviation 2.92	1.92 mmol/L Standard Deviation 2.79	-0.34 mmol/L Standard Deviation 2.18

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 1-hour PPG Baseline	12.77 mmol/L Standard Deviation 3.92	12.56 mmol/L Standard Deviation 5.08	13.06 mmol/L Standard Deviation 3.86
Change in 1-hour PPG Change from baseline	-0.15 mmol/L Standard Deviation 4.39	2.54 mmol/L Standard Deviation 4.43	-0.63 mmol/L Standard Deviation 4.73

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 1-hour PPG Increment Baseline	4.93 mmol/L Standard Deviation 3.34	5.08 mmol/L Standard Deviation 4.21	5.36 mmol/L Standard Deviation 2.77
Change in 1-hour PPG Increment Change from baseline	0.42 mmol/L Standard Deviation 4.93	2.63 mmol/L Standard Deviation 4.03	-0.52 mmol/L Standard Deviation 3.17

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 2-hour PPG Baseline	12.50 mmol/L Standard Deviation 4.63	12.54 mmol/L Standard Deviation 5.74	12.37 mmol/L Standard Deviation 4.74
Change in 2-hour PPG Change from baseline	0.69 mmol/L Standard Deviation 5.88	1.80 mmol/L Standard Deviation 5.08	-0.75 mmol/L Standard Deviation 5.64

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in 2-hour PPG Increment Baseline	4.66 mmol/L Standard Deviation 4.22	5.06 mmol/L Standard Deviation 5.04	4.67 mmol/L Standard Deviation 3.83
Change in 2-hour PPG Increment Change from baseline	1.26 mmol/L Standard Deviation 6.81	1.62 mmol/L Standard Deviation 5.03	-0.64 mmol/L Standard Deviation 4.43

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in AUCIG,0-15min Baseline	8.01 mmol/L Standard Deviation 2.72	7.49 mmol/L Standard Deviation 2.07	7.66 mmol/L Standard Deviation 1.96
Change in AUCIG,0-15min Change from baseline	-1.27 mmol/L Standard Deviation 3.68	0.08 mmol/L Standard Deviation 2.48	-0.53 mmol/L Standard Deviation 2.85

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in AUCIG,0-30min Baseline	8.28 mmol/L Standard Deviation 2.75	7.80 mmol/L Standard Deviation 2.13	8.13 mmol/L Standard Deviation 1.87
Change in AUCIG,0-30min Change from baseline	-1.15 mmol/L Standard Deviation 3.62	0.22 mmol/L Standard Deviation 2.52	-0.47 mmol/L Standard Deviation 2.81

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in AUCIG,0-1h Change from baseline	-0.87 mmol/L Standard Deviation 3.71	0.54 mmol/L Standard Deviation 3.00	-0.65 mmol/L Standard Deviation 2.91
Change in AUCIG,0-1h Baseline	9.63 mmol/L Standard Deviation 2.90	9.43 mmol/L Standard Deviation 2.71	10.02 mmol/L Standard Deviation 2.19

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in AUCIG,0-2h Baseline	11.40 mmol/L Standard Deviation 3.20	11.48 mmol/L Standard Deviation 3.43	11.76 mmol/L Standard Deviation 2.80
Change in AUCIG,0-2h Change from baseline	-0.84 mmol/L Standard Deviation 3.93	0.75 mmol/L Standard Deviation 3.74	-0.86 mmol/L Standard Deviation 3.61

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in AUCIG,0-4h Baseline	11.21 mmol/L Standard Deviation 3.25	11.19 mmol/L Standard Deviation 3.47	11.46 mmol/L Standard Deviation 3.21
Change in AUCIG,0-4h Change from baseline	-0.38 mmol/L Standard Deviation 3.96	0.62 mmol/L Standard Deviation 3.97	-1.30 mmol/L Standard Deviation 4.13

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Time to the IG Peak After Start of Meal Baseline	102.85 Minute Standard Deviation 48.93	94.26 Minute Standard Deviation 38.22	93.80 Minute Standard Deviation 39.19
Change in Time to the IG Peak After Start of Meal Change from baseline	5.29 Minute Standard Deviation 55.42	-0.04 Minute Standard Deviation 42.05	-8.76 Minute Standard Deviation 52.17

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in IG Peak After Start of Meal Baseline	14.87 mmol/L Standard Deviation 3.55	15.15 mmol/L Standard Deviation 4.52	15.11 mmol/L Standard Deviation 3.62
Change in IG Peak After Start of Meal Change from baseline	-0.55 mmol/L Standard Deviation 3.77	1.11 mmol/L Standard Deviation 4.88	-1.36 mmol/L Standard Deviation 4.36

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total Severe	3 Episodes	8 Episodes	4 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total Documented symptomatic	5391 Episodes	5712 Episodes	5170 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total Asymptomatic	4255 Episodes	3781 Episodes	3656 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total Probable symptomatic	12 Episodes	10 Episodes	24 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total Pseudo-hypoglycaemia	35 Episodes	37 Episodes	47 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total Unclassifiable	5 Episodes	2 Episodes	1 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime Severe	3 Episodes	5 Episodes	3 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime Documented symptomatic	4895 Episodes	5077 Episodes	4779 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime Asymptomatic	3584 Episodes	3163 Episodes	3101 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime Probable symptomatic	10 Episodes	10 Episodes	22 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime Pseudo-hypoglycaemia	32 Episodes	31 Episodes	42 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime Unclassifiable	5 Episodes	2 Episodes	1 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Asymptomatic	671 Episodes	618 Episodes	555 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Pseudo-hypoglycaemia	3 Episodes	6 Episodes	5 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Severe	0 Episodes	3 Episodes	1 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Documented symptomatic	496 Episodes	635 Episodes	391 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Probable symptomatic	2 Episodes	0 Episodes	2 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Unclassifiable	0 Episodes	0 Episodes	0 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total Severe	3 Episodes	8 Episodes	4 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total BG confirmed	3580 Episodes	3586 Episodes	3272 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total Severe or BG confirmed symptomatic	2242 Episodes	2427 Episodes	2194 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total Severe or BG confirmed	3583 Episodes	3594 Episodes	3276 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total Unclassifiable	6118 Episodes	5956 Episodes	5626 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime Severe	3 Episodes	5 Episodes	3 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime BG confirmed	3184 Episodes	3112 Episodes	2960 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime Severe or BG confirmed symptomatic	2062 Episodes	2167 Episodes	2035 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime Severe or BG confirmed	3187 Episodes	3117 Episodes	2963 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime Unclassifiable	5342 Episodes	5171 Episodes	4985 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) BG confirmed	396 Episodes	474 Episodes	312 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Severe or BG confirmed	396 Episodes	477 Episodes	313 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Severe	0 Episodes	3 Episodes	1 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Severe or BG confirmed symptomatic	180 Episodes	260 Episodes	159 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Unclassifiable	776 Episodes	785 Episodes	641 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Severe	0 Episodes	0 Episodes	0 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Documented symptomatic	178 Episodes	113 Episodes	157 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Asymptomatic	77 Episodes	51 Episodes	55 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Probable symptomatic	0 Episodes	0 Episodes	1 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Pseudo-hypoglycaemia	1 Episodes	2 Episodes	1 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Unclassifiable	0 Episodes	0 Episodes	0 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Probable symptomatic	1 Episodes	1 Episodes	7 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Severe	2 Episodes	1 Episodes	1 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Documented symptomatic	1125 Episodes	882 Episodes	1016 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Asymptomatic	421 Episodes	268 Episodes	303 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Pseudo-hypoglycaemia	6 Episodes	6 Episodes	4 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Unclassifiable	0 Episodes	0 Episodes	0 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Severe	3 Episodes	1 Episodes	2 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Documented symptomatic	3041 Episodes	3064 Episodes	2812 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Asymptomatic	1340 Episodes	1194 Episodes	1168 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Probable symptomatic	4 Episodes	8 Episodes	16 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Pseudo-hypoglycaemia	15 Episodes	18 Episodes	17 Episodes
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Unclassifiable	2 Episodes	0 Episodes	0 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Documented symptomatic	1916 Episodes	2182 Episodes	1796 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Asymptomatic	919 Episodes	926 Episodes	865 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Unclassifiable	2 Episodes	0 Episodes	0 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Probable symptomatic	3 Episodes	7 Episodes	9 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Severe	1 Episodes	0 Episodes	1 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Pseudo-hypoglycaemia	9 Episodes	12 Episodes	13 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
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 Severe or BG confirmed	119 Episodes	66 Episodes	105 Episodes
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 Severe	0 Episodes	0 Episodes	0 Episodes
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 BG confirmed	119 Episodes	66 Episodes	105 Episodes
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 Severe or BG confirmed symptomatic	94 Episodes	49 Episodes	85 Episodes
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 Unclassifiable	137 Episodes	100 Episodes	109 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
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 Severe	2 Episodes	1 Episodes	1 Episodes
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 BG confirmed	715 Episodes	504 Episodes	600 Episodes
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 Severe or BG confirmed symptomatic	572 Episodes	414 Episodes	495 Episodes
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 Severe or BG confirmed	717 Episodes	505 Episodes	601 Episodes
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 Unclassifiable	838 Episodes	653 Episodes	730 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
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 Severe	3 Episodes	1 Episodes	2 Episodes
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 BG confirmed	1774 Episodes	1781 Episodes	1666 Episodes
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 Severe or BG confirmed symptomatic	1365 Episodes	1375 Episodes	1277 Episodes
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 Severe or BG confirmed	1777 Episodes	1782 Episodes	1668 Episodes
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 Unclassifiable	2628 Episodes	2503 Episodes	2347 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification Severe	1 Episodes	0 Episodes	1 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification BG confirmed	1059 Episodes	1277 Episodes	1066 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification Severe or BG confirmed symptomatic	793 Episodes	961 Episodes	782 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification Severe or BG confirmed	1060 Episodes	1277 Episodes	1067 Episodes
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification Unclassifiable	1790 Episodes	1850 Episodes	1617 Episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Adverse Events (AEs)	576 Events	678 Events	593 Events

SECONDARY outcome

Timeframe: Week 0-26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Number of Treatment Emergent Injection Site Reactions	11 Events	31 Events	17 Events

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Physical Examination 4) Last on-treatment: Abnormal, NCS	0 Participants	4 Participants	3 Participants
Change in Physical Examination 4) Last on-treatment: Abnormal, CS	0 Participants	1 Participants	0 Participants
Change in Physical Examination 5) Baseline: Normal	251 Participants	238 Participants	245 Participants
Change in Physical Examination 5) Baseline: Abnormal, NCS	9 Participants	13 Participants	11 Participants
Change in Physical Examination 5) Baseline: Abnormal, CS	1 Participants	7 Participants	2 Participants
Change in Physical Examination 5) Last on-treatment: Normal	247 Participants	244 Participants	242 Participants
Change in Physical Examination 5) Last on-treatment: Abnormal, NCS	7 Participants	11 Participants	14 Participants
Change in Physical Examination 5) Last on-treatment: Abnormal, CS	3 Participants	3 Participants	1 Participants
Change in Physical Examination 6) Baseline: Normal	259 Participants	252 Participants	254 Participants
Change in Physical Examination 6) Baseline: Abnormal, NCS	2 Participants	4 Participants	3 Participants
Change in Physical Examination 6) Baseline: Abnormal, CS	0 Participants	2 Participants	1 Participants
Change in Physical Examination 6) Last on-treatment: Normal	254 Participants	253 Participants	253 Participants
Change in Physical Examination 6) Last on-treatment: Abnormal, NCS	1 Participants	3 Participants	3 Participants
Change in Physical Examination 6) Last on-treatment: Abnormal, CS	2 Participants	2 Participants	1 Participants
Change in Physical Examination 7) Baseline: Normal	259 Participants	256 Participants	256 Participants
Change in Physical Examination 7) Baseline: Abnormal, NCS	1 Participants	2 Participants	1 Participants
Change in Physical Examination 7) Baseline: Abnormal, CS	1 Participants	0 Participants	1 Participants
Change in Physical Examination 7) Last on-treatment: Normal	257 Participants	258 Participants	257 Participants
Change in Physical Examination 7) Last on-treatment: Abnormal, NCS	0 Participants	0 Participants	0 Participants
Change in Physical Examination 1) Baseline: Abnormal, CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination 1) Last on-treatment: Abnormal, CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination 2) Baseline: Abnormal, NCS	3 Participants	4 Participants	0 Participants
Change in Physical Examination 2) Last on-treatment: Abnormal, CS	0 Participants	1 Participants	0 Participants
Change in Physical Examination 4) Baseline: Abnormal, NCS	2 Participants	3 Participants	4 Participants
Change in Physical Examination 8) Baseline: Normal	239 Participants	237 Participants	238 Participants
Change in Physical Examination 8) Last on-treatment: Abnormal, CS	9 Participants	3 Participants	5 Participants
Change in Physical Examination 7) Last on-treatment: Abnormal, CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination 8) Baseline: Abnormal, NCS	18 Participants	21 Participants	16 Participants
Change in Physical Examination 8) Baseline: Abnormal, CS	4 Participants	0 Participants	4 Participants
Change in Physical Examination 8) Last on-treatment: Normal	229 Participants	233 Participants	235 Participants
Change in Physical Examination 8) Last on-treatment: Abnormal, NCS	19 Participants	22 Participants	17 Participants
Change in Physical Examination 1) Baseline: Normal	260 Participants	254 Participants	258 Participants
Change in Physical Examination 1) Baseline: Abnormal, NCS	1 Participants	4 Participants	0 Participants
Change in Physical Examination 1) Last on-treatment: Normal	257 Participants	253 Participants	257 Participants
Change in Physical Examination 1) Last on-treatment: Abnormal, NCS	0 Participants	5 Participants	0 Participants
Change in Physical Examination 2) Baseline: Normal	257 Participants	253 Participants	258 Participants
Change in Physical Examination 2) Baseline: Abnormal, CS	1 Participants	1 Participants	0 Participants
Change in Physical Examination 2) Last on-treatment: Normal	255 Participants	253 Participants	257 Participants
Change in Physical Examination 2) Last on-treatment: Abnormal, NCS	2 Participants	4 Participants	0 Participants
Change in Physical Examination 3) Baseline: Normal	258 Participants	257 Participants	254 Participants
Change in Physical Examination 3) Baseline: Abnormal, NCS	3 Participants	1 Participants	3 Participants
Change in Physical Examination 3) Baseline: Abnormal, CS	0 Participants	0 Participants	1 Participants
Change in Physical Examination 3) Last on-treatment: Normal	253 Participants	257 Participants	256 Participants
Change in Physical Examination 3) Last on-treatment: Abnormal, NCS	4 Participants	1 Participants	0 Participants
Change in Physical Examination 3) Last on-treatment: Abnormal, CS	0 Participants	0 Participants	1 Participants
Change in Physical Examination 4) Baseline: Normal	258 Participants	253 Participants	254 Participants
Change in Physical Examination 4) Baseline: Abnormal, CS	1 Participants	2 Participants	0 Participants
Change in Physical Examination 4) Last on-treatment: Normal	257 Participants	253 Participants	254 Participants

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Vital Sign: Blood Pressure SBP: Change from baseline	0.8 mmHg Standard Deviation 11.0	1.5 mmHg Standard Deviation 10.4	1.1 mmHg Standard Deviation 10.1
Change in Vital Sign: Blood Pressure SBP: Baseline	106.4 mmHg Standard Deviation 11.8	107.0 mmHg Standard Deviation 12.6	106.8 mmHg Standard Deviation 11.4
Change in Vital Sign: Blood Pressure DBP: Baseline	65.4 mmHg Standard Deviation 8.3	65.7 mmHg Standard Deviation 9.4	65.4 mmHg Standard Deviation 7.9
Change in Vital Sign: Blood Pressure DBP: Change from baseline	1.2 mmHg Standard Deviation 9.1	1.4 mmHg Standard Deviation 9.3	1.4 mmHg Standard Deviation 8.3

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Vital Sign: Pulse Baseline	80.6 Beats/minute Standard Deviation 11.8	80.5 Beats/minute Standard Deviation 11.8	79.4 Beats/minute Standard Deviation 11.8
Change in Vital Sign: Pulse Change from baseline	-0.6 Beats/minute Standard Deviation 10.3	0.3 Beats/minute Standard Deviation 10.8	0.7 Beats/minute Standard Deviation 11.0

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Body Weight Baseline	46.69 kg Standard Deviation 18.15	46.48 kg Standard Deviation 18.98	46.28 kg Standard Deviation 17.18
Change in Body Weight Change from baseline	2.21 kg Standard Deviation 2.57	1.90 kg Standard Deviation 2.32	2.15 kg Standard Deviation 2.80

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Height Baseline	1.50 Meter Standard Deviation 0.21	1.50 Meter Standard Deviation 0.21	1.50 Meter Standard Deviation 0.19
Change in Height Change from baseline	0.02 Meter Standard Deviation 0.02	0.02 Meter Standard Deviation 0.02	0.02 Meter Standard Deviation 0.02

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Body Mass Index Baseline	19.68 kg/m^2 Standard Deviation 3.75	19.67 kg/m^2 Standard Deviation 4.02	19.64 kg/m^2 Standard Deviation 3.78
Change in Body Mass Index Change from baseline	0.37 kg/m^2 Standard Deviation 0.92	0.28 kg/m^2 Standard Deviation 0.92	0.34 kg/m^2 Standard Deviation 1.10

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in SD Score of Body Weight Baseline	0.349 Standard deviation score Standard Deviation 0.945	0.351 Standard deviation score Standard Deviation 0.936	0.361 Standard deviation score Standard Deviation 0.875
Change in SD Score of Body Weight Change from baseline	0.034 Standard deviation score Standard Deviation 0.231	0.008 Standard deviation score Standard Deviation 0.223	0.030 Standard deviation score Standard Deviation 0.250

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in SD Score of Body Mass Index Baseline	0.296 Standard deviation score Standard Deviation 0.895	0.298 Standard deviation score Standard Deviation 0.936	0.317 Standard deviation score Standard Deviation 0.898
Change in SD Score of Body Mass Index Change from baseline	0.016 Standard deviation score Standard Deviation 0.308	0.004 Standard deviation score Standard Deviation 0.370	0.007 Standard deviation score Standard Deviation 0.338

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Haematology: Haemoglobin Baseline	8.33 mmol/L Standard Deviation 0.72	8.47 mmol/L Standard Deviation 0.74	8.41 mmol/L Standard Deviation 0.77
Change in Haematology: Haemoglobin Change from baseline	0.08 mmol/L Standard Deviation 0.51	0.09 mmol/L Standard Deviation 0.62	0.09 mmol/L Standard Deviation 0.52

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Haematology: Haematocrit Baseline	40.87 % of red blood cells Standard Deviation 3.39	41.51 % of red blood cells Standard Deviation 3.50	41.34 % of red blood cells Standard Deviation 3.75
Change in Haematology: Haematocrit Change from baseline	0.45 % of red blood cells Standard Deviation 2.86	0.40 % of red blood cells Standard Deviation 3.09	0.32 % of red blood cells Standard Deviation 2.75

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Haematology: Erythrocytes Baseline	4.81 10^12 cells/L Standard Deviation 0.39	4.87 10^12 cells/L Standard Deviation 0.39	4.88 10^12 cells/L Standard Deviation 0.40
Change in Haematology: Erythrocytes Change from baseline	0.02 10^12 cells/L Standard Deviation 0.27	0.04 10^12 cells/L Standard Deviation 0.31	0.02 10^12 cells/L Standard Deviation 0.26

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Haematology: Thrombocytes Baseline	268.1 10^9 cells/L Standard Deviation 64.5	270.0 10^9 cells/L Standard Deviation 60.2	262.5 10^9 cells/L Standard Deviation 57.9
Change in Haematology: Thrombocytes Change from baseline	1.2 10^9 cells/L Standard Deviation 47.3	1.6 10^9 cells/L Standard Deviation 45.4	6.0 10^9 cells/L Standard Deviation 44.9

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Haematology: Leukocytes Baseline	6.10 10^9 cells/L Standard Deviation 1.65	6.10 10^9 cells/L Standard Deviation 1.63	6.11 10^9 cells/L Standard Deviation 1.81
Change in Haematology: Leukocytes Change from baseline	0.08 10^9 cells/L Standard Deviation 1.66	0.14 10^9 cells/L Standard Deviation 1.74	0.10 10^9 cells/L Standard Deviation 1.67

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Creatinine Baseline	51.8 umol/L Standard Deviation 14.2	52.6 umol/L Standard Deviation 13.3	52.1 umol/L Standard Deviation 12.3
Change in Biochemistry: Creatinine Change from baseline	1.1 umol/L Standard Deviation 7.8	1.5 umol/L Standard Deviation 6.9	1.7 umol/L Standard Deviation 6.8

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Alanine Aminotransferase (ALT) Baseline	14.4 U/L Standard Deviation 6.4	14.7 U/L Standard Deviation 7.4	14.8 U/L Standard Deviation 5.6
Change in Biochemistry: Alanine Aminotransferase (ALT) Change from baseline	0.1 U/L Standard Deviation 6.9	1.3 U/L Standard Deviation 14.9	0.5 U/L Standard Deviation 5.9

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Aspartate Aminotransferase (AST) Baseline	19.9 U/L Standard Deviation 6.8	20.0 U/L Standard Deviation 5.6	20.5 U/L Standard Deviation 5.9
Change in Biochemistry: Aspartate Aminotransferase (AST) Change from baseline	0.1 U/L Standard Deviation 6.2	1.1 U/L Standard Deviation 11.7	-0.4 U/L Standard Deviation 5.0

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Alkaline Phosphatase (AP) Baseline	212.7 U/L Standard Deviation 135.8	209.8 U/L Standard Deviation 94.9	226.2 U/L Standard Deviation 93.6
Change in Biochemistry: Alkaline Phosphatase (AP) Change from baseline	-3.0 U/L Standard Deviation 119.0	-1.7 U/L Standard Deviation 50.8	-2.8 U/L Standard Deviation 80.4

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Sodium Baseline	139.5 mmol/L Standard Deviation 2.5	139.6 mmol/L Standard Deviation 2.4	139.7 mmol/L Standard Deviation 2.5
Change in Biochemistry: Sodium Change from baseline	0.5 mmol/L Standard Deviation 2.8	0.3 mmol/L Standard Deviation 2.7	0.04 mmol/L Standard Deviation 2.8

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Potassium Baseline	4.48 mmol/L Standard Deviation 0.34	4.52 mmol/L Standard Deviation 0.34	4.52 mmol/L Standard Deviation 0.40
Change in Biochemistry: Potassium Change from baseline	0.02 mmol/L Standard Deviation 0.41	-0.06 mmol/L Standard Deviation 0.34	0.01 mmol/L Standard Deviation 0.50

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Albumin Baseline	4.47 g/dL Standard Deviation 0.24	4.51 g/dL Standard Deviation 0.24	4.50 g/dL Standard Deviation 0.25
Change in Biochemistry: Albumin Change from baseline	0.01 g/dL Standard Deviation 0.24	0.01 g/dL Standard Deviation 0.25	0.005 g/dL Standard Deviation 0.24

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Biochemistry: Total Bilirubin Baseline	7.9 umol/L Standard Deviation 6.0	7.9 umol/L Standard Deviation 5.3	8.0 umol/L Standard Deviation 6.2
Change in Biochemistry: Total Bilirubin Change from baseline	0.2 umol/L Standard Deviation 4.9	0.2 umol/L Standard Deviation 3.4	0.3 umol/L Standard Deviation 4.1

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Lipid Profile: Total Cholesterol	0.989 Ratio Geometric Coefficient of Variation 13.869	1.023 Ratio Geometric Coefficient of Variation 13.742	1.016 Ratio Geometric Coefficient of Variation 13.187

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Lipid Profile: High Density Lipoproteins (HDL)	1.004 Ratio Geometric Coefficient of Variation 17.865	1.030 Ratio Geometric Coefficient of Variation 20.180	1.023 Ratio Geometric Coefficient of Variation 17.852

SECONDARY outcome

Timeframe: Week 0, Week 26

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

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Lipid Profile: Low Density Lipoproteins (LDL)	1.014 Ratio Geometric Coefficient of Variation 19.533	1.040 Ratio Geometric Coefficient of Variation 19.685	1.041 Ratio Geometric Coefficient of Variation 19.864

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Anti-insulin Aspart Antibody Development: Specific Baseline	1.436 Percentage of B/T Standard Deviation 3.159	1.459 Percentage of B/T Standard Deviation 5.313	1.183 Percentage of B/T Standard Deviation 2.134
Change in Anti-insulin Aspart Antibody Development: Specific Change from baseline	-0.099 Percentage of B/T Standard Deviation 1.015	-0.213 Percentage of B/T Standard Deviation 1.661	-0.201 Percentage of B/T Standard Deviation 1.238

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin Baseline	18.794 Percentage of B/T Standard Deviation 17.189	21.576 Percentage of B/T Standard Deviation 17.721	20.156 Percentage of B/T Standard Deviation 17.315
Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin Change from baseline	-3.202 Percentage of B/T Standard Deviation 6.989	-4.845 Percentage of B/T Standard Deviation 7.034	-3.802 Percentage of B/T Standard Deviation 7.587

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Measure	Faster Aspart (Meal) n=260 Participants 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.	Faster Aspart (Post) n=259 Participants 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.	NovoRapid (Meal) n=258 Participants 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.
Change in Anti-insulin Aspart Antibody Development: Total Baseline	20.230 Percentage of B/T Standard Deviation 17.795	23.044 Percentage of B/T Standard Deviation 18.070	21.344 Percentage of B/T Standard Deviation 17.825
Change in Anti-insulin Aspart Antibody Development: Total Change from baseline	-3.271 Percentage of B/T Standard Deviation 7.158	-5.061 Percentage of B/T Standard Deviation 7.193	-4.004 Percentage of B/T Standard Deviation 7.700

Adverse Events

Faster Aspart (Meal)

Serious events: 5 serious events

Other events: 137 other events

Deaths: 0 deaths

Faster Aspart (Post)

Serious events: 13 serious events

Other events: 149 other events

Deaths: 0 deaths

NovoRapid (Meal)

Serious events: 9 serious events

Other events: 136 other events

Deaths: 0 deaths

Serious adverse events

Measure	Faster Aspart (Meal) n=261 participants at risk 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.	Faster Aspart (Post) n=258 participants at risk 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.	NovoRapid (Meal) n=258 participants at risk 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Injury, poisoning and procedural complications Accidental overdose	0.38% 1/261 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.78% 2/258 • Number of events 2 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Psychiatric disorders Adjustment disorder with mixed disturbance of emotion and conduct	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Appendicitis	0.77% 2/261 • Number of events 2 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Surgical and medical procedures Diabetes mellitus management	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.78% 2/258 • Number of events 2 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.78% 2/258 • Number of events 2 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Musculoskeletal and connective tissue disorders Epiphysiolysis	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Gastrointestinal disorders Gastritis	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 2 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Gastroenteritis	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	1.2% 3/258 • Number of events 3 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Gastrointestinal viral infection	0.38% 1/261 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Metabolism and nutrition disorders Hypoglycaemia	0.38% 1/261 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.78% 2/258 • Number of events 2 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Nervous system disorders Hypoglycaemic unconsciousness	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.78% 2/258 • Number of events 2 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Nervous system disorders Idiopathic partial epilepsy	0.38% 1/261 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Influenza	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Osteomyelitis	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Cardiac disorders Palpitations	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Pneumonia	0.38% 1/261 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Renal and urinary disorders Renal colic	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Tonsillitis	0.00% 0/261 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.00% 0/258 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	0.39% 1/258 • Number of events 1 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.

Other adverse events

Measure	Faster Aspart (Meal) n=261 participants at risk 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.	Faster Aspart (Post) n=258 participants at risk 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.	NovoRapid (Meal) n=258 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 10/261 • Number of events 11 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	4.3% 11/258 • Number of events 14 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	6.2% 16/258 • Number of events 21 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Gastroenteritis	5.0% 13/261 • Number of events 15 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	6.2% 16/258 • Number of events 17 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	7.4% 19/258 • Number of events 24 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Nervous system disorders Headache	6.1% 16/261 • Number of events 21 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	10.1% 26/258 • Number of events 38 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	8.5% 22/258 • Number of events 35 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Influenza	7.7% 20/261 • Number of events 28 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	5.4% 14/258 • Number of events 19 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	5.4% 14/258 • Number of events 21 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.8% 10/261 • Number of events 12 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	3.5% 9/258 • Number of events 13 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	5.0% 13/258 • Number of events 16 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
General disorders Pyrexia	8.4% 22/261 • Number of events 26 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	6.2% 16/258 • Number of events 16 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	7.0% 18/258 • Number of events 20 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Rhinitis	3.8% 10/261 • Number of events 16 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	6.2% 16/258 • Number of events 24 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	4.3% 11/258 • Number of events 16 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Upper respiratory tract infection	8.4% 22/261 • Number of events 31 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	12.4% 32/258 • Number of events 41 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	10.1% 26/258 • Number of events 32 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Viral infection	2.7% 7/261 • Number of events 8 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	3.5% 9/258 • Number of events 11 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	5.4% 14/258 • Number of events 20 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Infections and infestations Viral upper respiratory tract infection	23.0% 60/261 • Number of events 73 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	20.5% 53/258 • Number of events 79 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	18.6% 48/258 • Number of events 75 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.
Gastrointestinal disorders Vomiting	3.4% 9/261 • Number of events 9 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	8.1% 21/258 • Number of events 24 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.	2.7% 7/258 • Number of events 7 • Week 0 to week 26 + 7 days. Presented adverse events are treatment emergent. 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.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

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• Principal investigator is a sponsor employee 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
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Restriction type: OTHER