Trial Outcomes & Findings for Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes (NCT NCT02500706)

NCT ID: NCT02500706

Last Updated: 2019-06-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1108 participants
• Primary outcome timeframe: Week 0, week 26
• Results posted on: 2019-06-12

Participant Flow

The trial was conducted at 146 sites in 12 countries(number of sites indicates those that both screened and randomised subjects, unless otherwise noted)-Austria(4);Bulgaria(8); Canada(6); Germany(7); India(16); Israel(6); Italy(4); Japan(24); Russian Federation(10); Serbia(3); Taiwan(3); United States(55 sites screened/52 sites randomised subjects)

Eligible subjects were enrolled in a 8-week run-in period (1108 subjects) where subjects were switched from previous insulin treatment to insulin degludec once daily,and NovoRapid®/NovoLog® as mealtime bolus insulin. The basal insulin treatment was optimised using treat-to-target approach. 83 subjects were run-in failures and 1025 were randomised.

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

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 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Overall Study Adverse Event	0	0	1
Overall Study Lost to Follow-up	0	1	1
Overall Study Withdrawal by Subject	4	6	4
Overall Study Unclassified	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Total n=1025 Participants Total of all reporting groups
Age, Continuous	41.48 years STANDARD_DEVIATION 14.42 • n=5 Participants	41.02 years STANDARD_DEVIATION 14.59 • n=7 Participants	40.77 years STANDARD_DEVIATION 14.22 • n=5 Participants	41.09 years STANDARD_DEVIATION 14.40 • n=4 Participants
Sex: Female, Male Female	158 Participants n=5 Participants	155 Participants n=7 Participants	163 Participants n=5 Participants	476 Participants n=4 Participants
Sex: Female, Male Male	184 Participants n=5 Participants	186 Participants n=7 Participants	179 Participants n=5 Participants	549 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	329 Participants n=5 Participants	333 Participants n=7 Participants	330 Participants n=5 Participants	992 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	116 Participants n=5 Participants	131 Participants n=7 Participants	137 Participants n=5 Participants	384 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	6 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) White	219 Participants n=5 Participants	206 Participants n=7 Participants	198 Participants n=5 Participants	623 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Glycosylated hemoglobin (HbA1c)	7.46 percentage of HbA1c STANDARD_DEVIATION 0.68 • n=5 Participants	7.40 percentage of HbA1c STANDARD_DEVIATION 0.60 • n=7 Participants	7.41 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=5 Participants	7.42 percentage of HbA1c STANDARD_DEVIATION 0.70 • n=4 Participants

PRIMARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

Measure	Faster Aspart (Meal) n=332 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=332 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=326 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)	-1.13 mmol/L Standard Deviation 4.04	1.04 mmol/L Standard Deviation 3.53	-0.15 mmol/L Standard Deviation 3.78

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

Measure	Faster Aspart (Meal) n=341 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=336 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=338 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation	0.22 ug/mL Standard Deviation 2.23	-0.15 ug/mL Standard Deviation 2.10	0.22 ug/mL Standard Deviation 2.25

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 26 weeks after randomisation

Population: Analysis was based on FAS.

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation No	71.3 percentage of subjects	71.8 percentage of subjects	67.3 percentage of subjects
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation Yes	28.7 percentage of subjects	28.2 percentage of subjects	32.7 percentage of subjects

SECONDARY outcome

Timeframe: 26 weeks after randomisation

Population: Analysis was based on FAS.

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation Yes	25.7 percentage of subjects	26.4 percentage of subjects	30.4 percentage of subjects
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation No	74.3 percentage of subjects	73.6 percentage of subjects	69.6 percentage of subjects

SECONDARY outcome

Timeframe: 26 weeks after randomisation

Population: Analysis was based on FAS.

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation No	83.6 percentage of subjects	82.1 percentage of subjects	80.7 percentage of subjects
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation Yes	16.4 percentage of subjects	17.9 percentage of subjects	19.3 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

Measure	Faster Aspart (Meal) n=320 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=327 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=320 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile	-0.304 mmol/L Standard Deviation 1.928	-0.231 mmol/L Standard Deviation 1.846	-0.309 mmol/L Standard Deviation 2.060

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG all meals	-0.65 mmol/L Standard Deviation 2.26	-0.004 mmol/L Standard Deviation 2.19	-0.25 mmol/L Standard Deviation 2.33
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG breakfast	-0.83 mmol/L Standard Deviation 3.34	-0.03 mmol/L Standard Deviation 3.30	-0.31 mmol/L Standard Deviation 3.18
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG lunch	-0.59 mmol/L Standard Deviation 3.04	0.06 mmol/L Standard Deviation 2.98	-0.33 mmol/L Standard Deviation 3.38
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG main evening meal	-0.53 mmol/L Standard Deviation 3.55	-0.01 mmol/L Standard Deviation 3.56	-0.14 mmol/L Standard Deviation 3.22

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG increment breakfast	-1.14 mmol/L Standard Deviation 3.64	0.06 mmol/L Standard Deviation 3.51	-0.30 mmol/L Standard Deviation 3.16
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG increment lunch	-0.67 mmol/L Standard Deviation 3.20	-0.08 mmol/L Standard Deviation 3.10	-0.004 mmol/L Standard Deviation 3.31
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG increment main evening meal	-0.29 mmol/L Standard Deviation 3.70	0.34 mmol/L Standard Deviation 3.54	0.26 mmol/L Standard Deviation 3.49
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Change in PPG increment all meals	-0.72 mmol/L Standard Deviation 2.06	0.08 mmol/L Standard Deviation 1.98	-0.02 mmol/L Standard Deviation 2.01

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

Measure	Faster Aspart (Meal) n=331 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=335 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=331 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile	0.876 ratio Geometric Coefficient of Variation 47.490	0.875 ratio Geometric Coefficient of Variation 40.293	0.890 ratio Geometric Coefficient of Variation 41.978

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements Change in nocturnal increment-04:00 to breakfast	0.78 mmol/L Standard Deviation 4.95	1.01 mmol/L Standard Deviation 4.12	-0.02 mmol/L Standard Deviation 4.17
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements Change in nocturnal increment-bedtime to 04:00	0.14 mmol/L Standard Deviation 5.66	0.19 mmol/L Standard Deviation 6.41	0.45 mmol/L Standard Deviation 5.55
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements Change in nocturnal increment-bedtime to breakfast	0.86 mmol/L Standard Deviation 6.21	0.93 mmol/L Standard Deviation 6.24	0.33 mmol/L Standard Deviation 5.71

SECONDARY outcome

Timeframe: 26 weeks after randomisation

Population: Analysis was based on FAS.

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Yes	27.8 percentage of subjects	19.9 percentage of subjects	21.6 percentage of subjects
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L No	72.2 percentage of subjects	80.1 percentage of subjects	78.4 percentage of subjects

SECONDARY outcome

Timeframe: 26 weeks after randomisation

Population: Analysis was based on FAS.

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia Yes	24.6 percentage of subjects	18.8 percentage of subjects	20.5 percentage of subjects
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia No	75.4 percentage of subjects	81.2 percentage of subjects	79.5 percentage of subjects

SECONDARY outcome

Timeframe: 26 weeks after randomisation

Population: Analysis was based on FAS.

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia Yes	7.6 percentage of subjects	4.7 percentage of subjects	8.2 percentage of subjects
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia No	92.4 percentage of subjects	95.3 percentage of subjects	91.8 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0 to week 26 (+7 days)

Population: Analysis was based on SAS.

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0 to week 26 (+7 days)

Population: Analysis was based on SAS.

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0 to week 26 (+1 day)

Population: Analysis was based on SAS.

ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.

NN Classification:

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0 to week 26 (+1 day)

Population: Analysis was based on SAS.

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.

NN Classification:

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

Outcome measures

Measure	Faster Aspart (Meal) n=342 Participants Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 Participants Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 Participants After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) Daytime hypoglycaemic episodes	14570 hypoglycaemic episodes	15379 hypoglycaemic episodes	15257 hypoglycaemic episodes
Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) Nocturnal hypoglycaemic episodes	1190 hypoglycaemic episodes	1200 hypoglycaemic episodes	1263 hypoglycaemic episodes

SECONDARY outcome

Timeframe: Week 0 to week 26 (+1 day)

Population: Analysis was based on SAS.

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.

NN Classification:

• Severe: same as per ADA classification
• Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
• Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia
• Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia
• BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
• Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
• Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 0, week 26

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

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

Outcome measures

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

Adverse Events

Faster Aspart (Meal)

Serious events: 20 serious events

Other events: 154 other events

Deaths: 0 deaths

Faster Aspart (Post)

Serious events: 17 serious events

Other events: 152 other events

Deaths: 0 deaths

NovoRapid (Meal)

Serious events: 17 serious events

Other events: 161 other events

Deaths: 0 deaths

Serious adverse events

Measure	Faster Aspart (Meal) n=342 participants at risk Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 participants at risk Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 participants at risk After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Investigations Blood glucose fluctuation	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Infections and infestations Cellulitis	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
General disorders Chest pain	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Skull fractured base	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Musculoskeletal and connective tissue disorders Collagen disorder	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Psychiatric disorders Depression	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Nervous system disorders Diabetic neuropathy	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Infections and infestations Diverticulitis	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Extradural haematoma	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Fall	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Gastrointestinal disorders Gastritis	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Surgical and medical procedures Haemorrhoid operation	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Metabolism and nutrition disorders Hypoglycaemia	2.3% 8/342 • Number of events 8 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.88% 3/341 • Number of events 6 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	1.8% 6/342 • Number of events 6 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Metabolism and nutrition disorders Hypoglycaemia unawareness	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Nervous system disorders Hypoglycaemic coma	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Nervous system disorders Hypoglycaemic seizure	0.58% 2/342 • Number of events 2 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Nervous system disorders Hypoglycaemic unconsciousness	0.58% 2/342 • Number of events 2 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.88% 3/341 • Number of events 3 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.58% 2/342 • Number of events 2 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Surgical and medical procedures Inguinal hernia repair	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Infections and infestations Pilonidal cyst	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Nervous system disorders Polyneuropathy	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.59% 2/341 • Number of events 2 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/341 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Radius fracture	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Tendon rupture	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Musculoskeletal and connective tissue disorders Trigger finger	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Ulna fracture	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Infections and infestations Urinary tract infection	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.29% 1/342 • Number of events 1 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Injury, poisoning and procedural complications Wrong drug administered	0.00% 0/342 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.00% 0/341 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	0.58% 2/342 • Number of events 2 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

Other adverse events

Measure	Faster Aspart (Meal) n=342 participants at risk Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	Faster Aspart (Post) n=341 participants at risk Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.	NovoRapid (Meal) n=342 participants at risk After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.
Investigations Blood glucose decreased	17.0% 58/342 • Number of events 81 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	19.6% 67/341 • Number of events 83 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	19.9% 68/342 • Number of events 82 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Infections and infestations Influenza	6.1% 21/342 • Number of events 22 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	4.1% 14/341 • Number of events 14 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	2.9% 10/342 • Number of events 10 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Infections and infestations Upper respiratory tract infection	8.8% 30/342 • Number of events 38 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	7.6% 26/341 • Number of events 34 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	7.9% 27/342 • Number of events 34 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Infections and infestations Viral upper respiratory tract infection	21.3% 73/342 • Number of events 101 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	20.5% 70/341 • Number of events 100 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.	23.4% 80/342 • Number of events 118 • Week 0 to week 26 (+7 days) A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• 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.
• Publication restrictions are in place

Restriction type: OTHER