Trial Outcomes & Findings for Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes (NCT NCT02825251)

NCT ID: NCT02825251

Last Updated: 2019-11-21

Results Overview

Change from baseline (week 0) in HbA1c was evaluated after 16 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: 472 participants
• Primary outcome timeframe: Week 0, week 16
• Results posted on: 2019-11-21

Participant Flow

The trial was conducted at 92 sites in 9 countries.as follows: Belgium (7), Canada (8), France (10), Germany (9), Netherlands (9), Russian Federation (11), Slovenia (2), United Kingdom (6), and United States (30). One (1) site in the Netherlands screened, but didn't randomise any subject.

There was a 4-week run-in period primarily for reinforcement of subject training in trial procedures, diabetes education and collecting baseline assessments. Subjects remained on their pre-trial insulin treatment during the run-in period.

Participant milestones

Measure	Faster Aspart The subjects received faster aspart (basal-bolus regimen) by continuous subcutaneous insulin infusion (CSII) for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that blood glucose (BG) was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Study STARTED	236	236
Overall Study COMPLETED	233	230
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	Faster Aspart The subjects received faster aspart (basal-bolus regimen) by continuous subcutaneous insulin infusion (CSII) for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that blood glucose (BG) was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	4
Overall Study Unclassified	2	0

Baseline Characteristics

The full analysis (FAS) included all randomised subjects.

Baseline characteristics by cohort

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	Total n=472 Participants Total of all reporting groups
Age, Continuous	43.3 Years STANDARD_DEVIATION 14.8 • n=5 Participants • The full analysis (FAS) included all randomised subjects.	43.6 Years STANDARD_DEVIATION 14.7 • n=7 Participants • The full analysis (FAS) included all randomised subjects.	43.5 Years STANDARD_DEVIATION 14.7 • n=5 Participants • The full analysis (FAS) included all randomised subjects.
Sex: Female, Male Female	133 Participants n=5 Participants • The FAS included all randomised subjects.	136 Participants n=7 Participants • The FAS included all randomised subjects.	269 Participants n=5 Participants • The FAS included all randomised subjects.
Sex: Female, Male Male	103 Participants n=5 Participants • The FAS included all randomised subjects.	100 Participants n=7 Participants • The FAS included all randomised subjects.	203 Participants n=5 Participants • The FAS included all randomised subjects.
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants • The FAS included all randomised subjects.	6 Participants n=7 Participants • The FAS included all randomised subjects.	13 Participants n=5 Participants • The FAS included all randomised subjects.
Ethnicity (NIH/OMB) Not Hispanic or Latino	210 Participants n=5 Participants • The FAS included all randomised subjects.	215 Participants n=7 Participants • The FAS included all randomised subjects.	425 Participants n=5 Participants • The FAS included all randomised subjects.
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants • The FAS included all randomised subjects.	15 Participants n=7 Participants • The FAS included all randomised subjects.	34 Participants n=5 Participants • The FAS included all randomised subjects.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • The FAS included all randomised subjects.	2 Participants n=7 Participants • The FAS included all randomised subjects.	2 Participants n=5 Participants • The FAS included all randomised subjects.
Race (NIH/OMB) Asian	3 Participants n=5 Participants • The FAS included all randomised subjects.	3 Participants n=7 Participants • The FAS included all randomised subjects.	6 Participants n=5 Participants • The FAS included all randomised subjects.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • The FAS included all randomised subjects.	0 Participants n=7 Participants • The FAS included all randomised subjects.	0 Participants n=5 Participants • The FAS included all randomised subjects.
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants • The FAS included all randomised subjects.	5 Participants n=7 Participants • The FAS included all randomised subjects.	7 Participants n=5 Participants • The FAS included all randomised subjects.
Race (NIH/OMB) White	209 Participants n=5 Participants • The FAS included all randomised subjects.	210 Participants n=7 Participants • The FAS included all randomised subjects.	419 Participants n=5 Participants • The FAS included all randomised subjects.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • The FAS included all randomised subjects.	0 Participants n=7 Participants • The FAS included all randomised subjects.	0 Participants n=5 Participants • The FAS included all randomised subjects.
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants • The FAS included all randomised subjects.	16 Participants n=7 Participants • The FAS included all randomised subjects.	38 Participants n=5 Participants • The FAS included all randomised subjects.

PRIMARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in HbA1c was evaluated after 16 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change in Glycosylated Haemoglobin (HbA1c) Baseline	7.49 Percentage (%) of HbA1c Standard Deviation 0.55	7.49 Percentage (%) of HbA1c Standard Deviation 0.53
Change in Glycosylated Haemoglobin (HbA1c) Change from baseline	-0.06 Percentage (%) of HbA1c Standard Deviation 0.50	-0.14 Percentage (%) of HbA1c Standard Deviation 0.44

SECONDARY outcome

Timeframe: Week 0, Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in 1-hour PPG Increment Baseline	4.67 mmol/L Standard Deviation 3.09	4.62 mmol/L Standard Deviation 3.00
Change From Baseline in 1-hour PPG Increment Change from baseline	-0.89 mmol/L Standard Deviation 3.44	0.05 mmol/L Standard Deviation 3.37

SECONDARY outcome

Timeframe: Week 0, Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in 1,5-anhydroglucitol Baseline	4.20 ug/mL Standard Deviation 2.34	4.13 ug/mL Standard Deviation 2.14
Change From Baseline in 1,5-anhydroglucitol Change from baseline	0.14 ug/mL Standard Deviation 1.48	0.25 ug/mL Standard Deviation 1.42

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L [70 mg/dL]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM Baseline	85.42 min/day Standard Deviation 65.20	79.88 min/day Standard Deviation 60.46
Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM Change from baseline	-6.96 min/day Standard Deviation 55.29	2.85 min/day Standard Deviation 58.56

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Fasting Plasma Glucose (FPG) Change from baseline	-0.03 mmol/L Standard Deviation 3.19	0.25 mmol/L Standard Deviation 3.05
Change From Baseline in Fasting Plasma Glucose (FPG) Baseline	7.60 mmol/L Standard Deviation 2.64	7.40 mmol/L Standard Deviation 2.31

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)	20.3 % of subjects	23.3 % of subjects

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes	18.6 % of subjects	22.5 % of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 30-min (Baseline)	10.54 mmol/L Standard Deviation 3.33	10.30 mmol/L Standard Deviation 2.96
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 1-hour (Baseline)	12.18 mmol/L Standard Deviation 3.96	11.96 mmol/L Standard Deviation 3.81
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 2-hour (Baseline)	13.17 mmol/L Standard Deviation 4.77	13.04 mmol/L Standard Deviation 4.35
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 3-hour (Baseline)	11.38 mmol/L Standard Deviation 4.65	11.48 mmol/L Standard Deviation 4.28
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 4-hour (Baseline)	9.07 mmol/L Standard Deviation 4.31	9.18 mmol/L Standard Deviation 3.83
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 30-min (Change from baseline)	-0.50 mmol/L Standard Deviation 4.05	0.42 mmol/L Standard Deviation 3.75
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 1-hour (Change from baseline)	-0.85 mmol/L Standard Deviation 4.65	0.36 mmol/L Standard Deviation 4.58
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 2-hour (Change from baseline)	-0.80 mmol/L Standard Deviation 5.33	0.42 mmol/L Standard Deviation 5.01
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 3-hour (Change from baseline)	-0.33 mmol/L Standard Deviation 5.12	0.20 mmol/L Standard Deviation 4.75
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) 4-hour (Change from baseline)	0.00 mmol/L Standard Deviation 4.76	0.21 mmol/L Standard Deviation 4.10

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 4-hour (Baseline)	1.57 mmol/L Standard Deviation 4.23	1.83 mmol/L Standard Deviation 3.52
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 30-min (Baseline)	3.02 mmol/L Standard Deviation 2.16	2.95 mmol/L Standard Deviation 2.03
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 2-hour (Baseline)	5.65 mmol/L Standard Deviation 4.12	5.70 mmol/L Standard Deviation 3.66
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 3-hour (Baseline)	3.85 mmol/L Standard Deviation 4.32	4.13 mmol/L Standard Deviation 3.72
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 30-min (Change from baseline)	-0.53 mmol/L Standard Deviation 2.47	0.11 mmol/L Standard Deviation 2.25
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 2-hour (Change from baseline)	-0.82 mmol/L Standard Deviation 4.39	0.09 mmol/L Standard Deviation 4.13
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 3-hour (Change from baseline)	-0.35 mmol/L Standard Deviation 4.53	-0.14 mmol/L Standard Deviation 4.07
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) 4-hour (Change from baseline)	0.01 mmol/L Standard Deviation 4.50	-0.11 mmol/L Standard Deviation 3.76

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile Baseline	9.24 mmol/L Standard Deviation 1.71	9.10 mmol/L Standard Deviation 1.40
Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile Change from baseline	0.19 mmol/L Standard Deviation 1.91	0.10 mmol/L Standard Deviation 1.58

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (baseline)	10.82 mmol/L Standard Deviation 2.99	10.28 mmol/L Standard Deviation 3.07
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (baseline)	9.65 mmol/L Standard Deviation 3.05	9.62 mmol/L Standard Deviation 2.68
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (baseline)	9.79 mmol/L Standard Deviation 3.01	9.34 mmol/L Standard Deviation 3.06
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Mean over all meals (baseline)	10.07 mmol/L Standard Deviation 2.09	9.74 mmol/L Standard Deviation 1.99
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (Change from baseline)	-0.33 mmol/L Standard Deviation 3.61	0.23 mmol/L Standard Deviation 3.79
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (Change from baseline)	0.27 mmol/L Standard Deviation 3.75	0.05 mmol/L Standard Deviation 3.57
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (Change from baseline)	-0.35 mmol/L Standard Deviation 3.81	0.58 mmol/L Standard Deviation 3.61
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) Mean over all meals (Change from baseline)	0.06 mmol/L Standard Deviation 2.33	0.13 mmol/L Standard Deviation 2.21

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (baseline)	2.62 mmol/L Standard Deviation 3.16	1.93 mmol/L Standard Deviation 3.28
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (baseline)	1.80 mmol/L Standard Deviation 2.77	1.77 mmol/L Standard Deviation 2.47
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (baseline)	1.04 mmol/L Standard Deviation 3.07	0.52 mmol/L Standard Deviation 2.69
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Mean over all meals (baseline)	1.93 mmol/L Standard Deviation 1.94	1.48 mmol/L Standard Deviation 1.86
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (Change from baseline)	-0.75 mmol/L Standard Deviation 3.90	0.03 mmol/L Standard Deviation 3.67
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (Change from baseline)	-0.43 mmol/L Standard Deviation 3.25	-0.27 mmol/L Standard Deviation 3.13
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (Change from baseline)	-0.47 mmol/L Standard Deviation 3.51	0.35 mmol/L Standard Deviation 3.79
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) Mean over all meals (Change from baseline)	-0.53 mmol/L Standard Deviation 1.99	0.12 mmol/L Standard Deviation 1.92

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-breakfast (baseline)	8.40 mmol/L Standard Deviation 2.50	8.31 mmol/L Standard Deviation 2.32
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-lunch (baseline)	8.28 mmol/L Standard Deviation 2.85	8.21 mmol/L Standard Deviation 2.32
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-main evening meal (baseline)	8.68 mmol/L Standard Deviation 2.76	8.87 mmol/L Standard Deviation 2.62
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-mean over all meals (baseline)	8.39 mmol/L Standard Deviation 1.73	8.45 mmol/L Standard Deviation 1.54
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-breakfast (Change from baseline)	0.36 mmol/L Standard Deviation 3.33	0.26 mmol/L Standard Deviation 3.05
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-lunch (Change from baseline)	0.39 mmol/L Standard Deviation 3.54	0.21 mmol/L Standard Deviation 3.12
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-main evening meal (Change from baseline)	0.15 mmol/L Standard Deviation 3.72	0.13 mmol/L Standard Deviation 3.18
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) Pre-mean over all meals (Change from baseline)	0.39 mmol/L Standard Deviation 2.00	0.21 mmol/L Standard Deviation 1.84

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile Baseline	2.14 mmol/L Interval 0.4 to 4.9	2.05 mmol/L Interval 0.9 to 4.0
Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile Last in-trial value	2.06 mmol/L Interval 0.9 to 5.2	2.06 mmol/L Interval 0.7 to 3.8

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements 04:00 to breakfast (Baseline)	-1.29 mmol/L Standard Deviation 3.61	-1.06 mmol/L Standard Deviation 3.35
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements Bedtime to 04:00 (Baseline)	-0.97 mmol/L Standard Deviation 5.16	-0.56 mmol/L Standard Deviation 3.84
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements Bedtime to breakfast (Baseline)	-1.73 mmol/L Standard Deviation 4.81	-1.56 mmol/L Standard Deviation 3.83
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements 04:00 to breakfast (Change from baseline)	-0.50 mmol/L Standard Deviation 4.83	-0.08 mmol/L Standard Deviation 4.45
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements Bedtime to 04:00 (Change from baseline)	0.81 mmol/L Standard Deviation 6.59	0.18 mmol/L Standard Deviation 5.14
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements Bedtime to breakfast (Change from baseline)	0.13 mmol/L Standard Deviation 6.67	-0.20 mmol/L Standard Deviation 5.84

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]	8.1 % of subjects	7.6 % of subjects

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia	7.6 % of subjects	6.8 % of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) Total cholesterol (Baseline)	4.48 mmol/L Interval 2.6 to 8.1	4.68 mmol/L Interval 2.9 to 8.0
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) High density lipoproteins (Baseline)	1.70 mmol/L Interval 0.8 to 3.3	1.71 mmol/L Interval 0.8 to 3.8
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) Low density lipoproteins (Baseline)	2.46 mmol/L Interval 1.1 to 6.4	2.63 mmol/L Interval 1.2 to 6.6
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) Total cholesterol (Last in-trial value)	4.61 mmol/L Interval 2.8 to 7.2	4.57 mmol/L Interval 2.4 to 8.2
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) High density lipoproteins (Last in-trial value)	1.74 mmol/L Interval 0.9 to 3.1	1.74 mmol/L Interval 0.7 to 3.6
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) Low density lipoproteins (Last in-trial value)	2.56 mmol/L Interval 1.0 to 5.2	2.59 mmol/L Interval 1.1 to 6.4

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the investigational medicinal product (IMP, faster aspart) or its comparator (NovoRapid®/NovoLog®). Number analyzed = Number of subjects contributed to the analysis.

Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Dose in Units/Day: Total Basal	23.82 Unit (U) Standard Deviation 12.82	23.87 Unit (U) Standard Deviation 11.38

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Dose in Units/Day: Total Bolus	25.91 U Standard Deviation 17.46	25.27 U Standard Deviation 15.33

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Dose in Units/Day: Total Daily Insulin Dose	49.72 U Standard Deviation 27.08	49.12 U Standard Deviation 23.75

SECONDARY outcome

Timeframe: Week 16

Population: No subjects were analysed, as no data was collected for individual meal insulin dose.

No data was collected for individual meal insulin dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Dose in Units/kg/Day: Total Basal	0.30 U/Kg Standard Deviation 0.12	0.30 U/Kg Standard Deviation 0.11

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Dose in Units/kg/Day: Total Bolus	0.33 U/Kg Standard Deviation 0.17	0.31 U/Kg Standard Deviation 0.16

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Dose in Units/kg/Day: Total Daily Insulin Dose	0.63 U/Kg Standard Deviation 0.24	0.61 U/Kg Standard Deviation 0.23

SECONDARY outcome

Timeframe: Week 16

Population: No subjects were analysed, as no data was collected for individual meal insulin dose.

No data was collected for individual meal insulin dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio	9.13 Gram (g)/U Standard Deviation 3.20	9.74 Gram (g)/U Standard Deviation 6.77

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Glucose sensitivity factor was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Delivery Pump Parameter: Glucose Sensitivity Factor	2.65 mmol/L/U Standard Deviation 1.14	2.60 mmol/L/U Standard Deviation 0.98

SECONDARY outcome

Timeframe: Week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Active insulin time was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Insulin Delivery Pump Parameter: Active Insulin Time	3.6 Hour (h) Standard Deviation 0.7	3.6 Hour (h) Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast 0-30 min (Baseline)	0.23 mmol/L Standard Deviation 0.61	0.21 mmol/L Standard Deviation 0.60
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Lunch 0-30 min (Baseline)	0.02 mmol/L Standard Deviation 0.54	0.03 mmol/L Standard Deviation 0.60
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal 0-30 min (Baseline)	0.15 mmol/L Standard Deviation 0.52	0.09 mmol/L Standard Deviation 0.57
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals 0-30 min (Baseline)	0.13 mmol/L Standard Deviation 0.37	0.11 mmol/L Standard Deviation 0.39
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast 0-1 h (Baseline)	0.78 mmol/L Standard Deviation 0.97	0.73 mmol/L Standard Deviation 0.94
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Lunch 0-1 h (Baseline)	0.42 mmol/L Standard Deviation 0.77	0.44 mmol/L Standard Deviation 0.84
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal 0-1 h (Baseline)	0.39 mmol/L Standard Deviation 0.75	0.32 mmol/L Standard Deviation 0.82
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals 0-1 h (Baseline)	0.52 mmol/L Standard Deviation 0.57	0.50 mmol/L Standard Deviation 0.60
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast 0-2 h (Baseline)	1.32 mmol/L Standard Deviation 1.52	1.27 mmol/L Standard Deviation 1.46
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Lunch 0-2 h (Baseline)	0.99 mmol/L Standard Deviation 1.19	0.92 mmol/L Standard Deviation 1.07
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal 0-2 h (Baseline)	0.54 mmol/L Standard Deviation 1.15	0.50 mmol/L Standard Deviation 1.19
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals 0-2 h (Baseline)	0.93 mmol/L Standard Deviation 0.94	0.89 mmol/L Standard Deviation 0.84
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast 0-30 min (Change from baseline)	-0.03 mmol/L Standard Deviation 0.80	0.08 mmol/L Standard Deviation 0.67
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Lunch 0-30 min (Change from baseline)	0.05 mmol/L Standard Deviation 0.61	0.10 mmol/L Standard Deviation 0.68
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal 0-30 min (Change from baseline)	-0.07 mmol/L Standard Deviation 0.73	-0.01 mmol/L Standard Deviation 0.70
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals 0-30min:Change from baseline	-0.01 mmol/L Standard Deviation 0.46	0.06 mmol/L Standard Deviation 0.46
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast 0-1 h (Change from baseline)	-0.13 mmol/L Standard Deviation 1.13	0.14 mmol/L Standard Deviation 0.99
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Lunch 0-1 h (Change from baseline)	-0.02 mmol/L Standard Deviation 0.88	0.15 mmol/L Standard Deviation 0.99
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal 0-1 h (Change from baseline)	-0.16 mmol/L Standard Deviation 0.95	0.04 mmol/L Standard Deviation 0.97
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals 0-1 h (Change from baseline)	-0.10 mmol/L Standard Deviation 0.61	0.11 mmol/L Standard Deviation 0.66
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast 0-2 h (Change from baseline)	-0.28 mmol/L Standard Deviation 1.60	0.16 mmol/L Standard Deviation 1.45
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Lunch 0-2 h (Change from baseline)	-0.24 mmol/L Standard Deviation 1.32	0.22 mmol/L Standard Deviation 1.37
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal 0-2 h (Change from baseline)	-0.29 mmol/L Standard Deviation 1.29	-0.03 mmol/L Standard Deviation 1.27
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals 0-2 h (Change from baseline)	-0.25 mmol/L Standard Deviation 0.81	0.12 mmol/L Standard Deviation 0.86

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (Baseline)	88.95 Minutes Standard Deviation 25.66	97.29 Minutes Standard Deviation 32.32
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (Baseline)	109.47 Minutes Standard Deviation 31.78	106.94 Minutes Standard Deviation 29.67
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (Baseline)	110.11 Minutes Standard Deviation 32.35	106.91 Minutes Standard Deviation 29.61
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals (Baseline)	103.24 Minutes Standard Deviation 18.50	103.99 Minutes Standard Deviation 19.21
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (Change from baseline)	0.25 Minutes Standard Deviation 33.69	-4.03 Minutes Standard Deviation 35.49
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (Change from baseline)	-2.00 Minutes Standard Deviation 38.63	1.64 Minutes Standard Deviation 38.02
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (Change from baseline)	-2.04 Minutes Standard Deviation 40.51	-1.43 Minutes Standard Deviation 38.94
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals (Change from baseline)	-1.30 Minutes Standard Deviation 22.01	-1.00 Minutes Standard Deviation 21.90

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (Baseline)	12.43 mmol/L Standard Deviation 1.97	12.25 mmol/L Standard Deviation 2.09
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (Baseline)	12.42 mmol/L Standard Deviation 2.07	12.56 mmol/L Standard Deviation 1.84
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (Baseline)	12.65 mmol/L Standard Deviation 2.10	12.70 mmol/L Standard Deviation 2.06
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals (Baseline)	12.49 mmol/L Standard Deviation 1.67	12.51 mmol/L Standard Deviation 1.60
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Breakfast (Change from baseline)	0.10 mmol/L Standard Deviation 2.24	0.11 mmol/L Standard Deviation 2.11
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Lunch (Change from baseline)	0.10 mmol/L Standard Deviation 2.19	0.19 mmol/L Standard Deviation 1.92
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Main evening meal (Change from baseline)	0.22 mmol/L Standard Deviation 2.09	-0.13 mmol/L Standard Deviation 2.14
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) Mean across all meals (Change from baseline)	0.16 mmol/L Standard Deviation 1.63	0.03 mmol/L Standard Deviation 1.59

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤2.5 mmol/L (45 mg/dL)	1.11 % of time Standard Deviation 1.29	1.03 % of time Standard Deviation 1.38
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤3.0 mmol/L (54 mg/dL)	2.15 % of time Standard Deviation 1.98	2.19 % of time Standard Deviation 2.25
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤3.5 mmol/L (63 mg/dL)	3.75 % of time Standard Deviation 2.85	3.93 % of time Standard Deviation 3.37
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤3.9 mmol/L (70.2 mg/dL)	5.46 % of time Standard Deviation 3.68	5.76 % of time Standard Deviation 4.25
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG >10.0 mmol/L (180 mg/dL)	41.57 % of time Standard Deviation 13.09	39.24 % of time Standard Deviation 11.86
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG >12.0 mmol/L (216 mg/dL)	26.34 % of time Standard Deviation 11.66	24.23 % of time Standard Deviation 10.75
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG >13.9 mmol/L (250 mg/dL)	15.87 % of time Standard Deviation 9.42	14.23 % of time Standard Deviation 8.49

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤2.5 mmol/L (45 mg/dL)	1570 Number of Events	1532 Number of Events
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤3.0 mmol/L (54 mg/dL)	2848 Number of Events	2920 Number of Events
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤3.5 mmol/L (63 mg/dL)	4584 Number of Events	4742 Number of Events
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG ≤3.9 mmol/L (70 mg/dL)	6371 Number of Events	6576 Number of Events
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG >10.0 mmol/L (180 mg/dL)	35194 Number of Events	33176 Number of Events
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG >12.0 mmol/L (216 mg/dL)	23070 Number of Events	21276 Number of Events
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) IG >13.9 mmol/L (250 mg/dL)	14352 Number of Events	12866 Number of Events

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Mean of the IG Profile Baseline	9.38 mmol/L Standard Deviation 1.18	9.39 mmol/L Standard Deviation 1.20
Change From Baseline in Mean of the IG Profile Change from baseline	0.28 mmol/L Standard Deviation 1.27	0.04 mmol/L Standard Deviation 1.18

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) IG 4.0-7.8 mmol/L (71-140 mg/dL)	31.49 % of time Standard Deviation 9.97	33.11 % of time Standard Deviation 8.76
Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) IG 4.0-10.0 mmol/L (71-180 mg/dL)	52.40 % of time Standard Deviation 11.87	54.40 % of time Standard Deviation 10.70

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Variation in the IG Profile	3.09 mmol/L Interval 1.6 to 5.6	3.04 mmol/L Interval 1.6 to 5.1

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]	3.19 mmol/L Standard Deviation 0.22	3.21 mmol/L Standard Deviation 0.20

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in AUCIG,0-15min Baseline	7.55 mmol/L Standard Deviation 2.63	7.37 mmol/L Standard Deviation 2.20
Change From Baseline in AUCIG,0-15min Change from baseline	0.16 mmol/L Standard Deviation 3.06	0.21 mmol/L Standard Deviation 2.96

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in AUCIG,0-30min Baseline	7.98 mmol/L Standard Deviation 2.65	7.86 mmol/L Standard Deviation 2.25
Change From Baseline in AUCIG,0-30min Change from baseline	0.12 mmol/L Standard Deviation 3.12	0.22 mmol/L Standard Deviation 3.02

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in AUCIG,0-1h Baseline	9.47 mmol/L Standard Deviation 2.76	9.35 mmol/L Standard Deviation 2.38
Change From Baseline in AUCIG,0-1h Change from baseline	-0.07 mmol/L Standard Deviation 3.33	0.32 mmol/L Standard Deviation 3.26

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in AUCIG,0-2h Baseline	11.27 mmol/L Standard Deviation 3.10	11.18 mmol/L Standard Deviation 2.82
Change From Baseline in AUCIG,0-2h Change from baseline	-0.38 mmol/L Standard Deviation 3.76	0.37 mmol/L Standard Deviation 3.90

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in AUCIG,0-4h Baseline	11.31 mmol/L Standard Deviation 3.33	11.40 mmol/L Standard Deviation 3.03
Change From Baseline in AUCIG,0-4h Change from baseline	-0.32 mmol/L Standard Deviation 4.07	0.29 mmol/L Standard Deviation 4.10

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Time to the IG Peak After Start of Meal Baseline	111.2 Minute Standard Deviation 45.3	117.0 Minute Standard Deviation 43.0
Change From Baseline in Time to the IG Peak After Start of Meal Change from baseline	1.2 Minute Standard Deviation 50.5	-1.4 Minute Standard Deviation 51.6

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in IG Peak After Start of Meal Change from baseline	-0.57 mmol/L Standard Deviation 4.69	0.36 mmol/L Standard Deviation 4.78
Change From Baseline in IG Peak After Start of Meal Baseline	14.71 mmol/L Standard Deviation 3.94	14.69 mmol/L Standard Deviation 3.65

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Adverse Events (AEs)	440 Number of adverse events	412 Number of adverse events

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Infusion Site Reactions	44 Number of infusion site reaction events	32 Number of infusion site reaction events

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis. The results are based on the on-treatment period.

ADA classification of hypo:

1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.

2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms.

3. Asymptomatic: PG ≤3.9 mmol/L without symptoms.

4. Probable symptomatic: No measurement with symptoms.

5. Pseudo: PG >3.9 mmol/L with symptoms.

6. Unclassifiable.

NN classification of hypo:

1. BG confirmed: PG <3.1 mmol/L with/without symptoms.

2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.

3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.

4. Unclassifiable.

Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall ADA: Severe	21 Number of hypoglycaemic episodes	7 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall ADA: Documented symptomatic	8372 Number of hypoglycaemic episodes	8904 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall ADA: Asymptomatic	2530 Number of hypoglycaemic episodes	2273 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall ADA: Probable symptomatic	88 Number of hypoglycaemic episodes	32 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall ADA: Pseudo	56 Number of hypoglycaemic episodes	159 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall ADA: Unclassifiable	1 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall NN: BG confirmed	3258 Number of hypoglycaemic episodes	3240 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall NN: Severe or BG confirmed symptomatic	2751 Number of hypoglycaemic episodes	2779 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall NN: Severe or BG confirmed	3279 Number of hypoglycaemic episodes	3247 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall NN: Unclassifiable	7789 Number of hypoglycaemic episodes	8128 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) ADA: Severe	12 Number of hypoglycaemic episodes	5 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) ADA: Documented symptomatic	7508 Number of hypoglycaemic episodes	7889 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) ADA: Asymptomatic	2321 Number of hypoglycaemic episodes	2071 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) ADA: Probable symptomatic	70 Number of hypoglycaemic episodes	26 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) ADA: Pseudo	52 Number of hypoglycaemic episodes	144 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) NN: BG confirmed	2799 Number of hypoglycaemic episodes	2769 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) NN: Severe or BG confirmed symptomatic	2335 Number of hypoglycaemic episodes	2359 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) NN: Severe or BG confirmed	2811 Number of hypoglycaemic episodes	2774 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) NN: Unclassifiable	7152 Number of hypoglycaemic episodes	7361 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) ADA: Severe	9 Number of hypoglycaemic episodes	2 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) ADA: Documented symptomatic	864 Number of hypoglycaemic episodes	1015 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) ADA: Asymptomatic	209 Number of hypoglycaemic episodes	202 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) ADA: Probable symptomatic	18 Number of hypoglycaemic episodes	6 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) ADA: Pseudo	4 Number of hypoglycaemic episodes	15 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) ADA: Unclassifiable	1 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) NN: BG confirmed	459 Number of hypoglycaemic episodes	471 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) NN: Severe or BG confirmed symptomatic	416 Number of hypoglycaemic episodes	420 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) NN: Severe or BG confirmed	468 Number of hypoglycaemic episodes	473 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) NN: Unclassifiable	637 Number of hypoglycaemic episodes	767 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal ADA: Severe	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal ADA: Documented symptomatic	224 Number of hypoglycaemic episodes	190 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal ADA: Asymptomatic	31 Number of hypoglycaemic episodes	33 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal ADA: Probable symptomatic	1 Number of hypoglycaemic episodes	3 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal ADA: Pseudo	0 Number of hypoglycaemic episodes	5 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal NN: BG confirmed	92 Number of hypoglycaemic episodes	51 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal NN: Severe or BG confirmed symptomatic	81 Number of hypoglycaemic episodes	48 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal NN: Severe or BG confirmed	92 Number of hypoglycaemic episodes	51 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal NN: Unclassifiable	164 Number of hypoglycaemic episodes	180 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal ADA: Severe	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal ADA: Documented symptomatic	1258 Number of hypoglycaemic episodes	1077 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal ADA: Asymptomatic	176 Number of hypoglycaemic episodes	175 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal ADA: Probable symptomatic	9 Number of hypoglycaemic episodes	6 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal ADA: Pseudo	7 Number of hypoglycaemic episodes	34 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal NN: BG confirmed	482 Number of hypoglycaemic episodes	413 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal NN: Severe or BG confirmed symptomatic	441 Number of hypoglycaemic episodes	372 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal NN: Severe or BG confirmed	482 Number of hypoglycaemic episodes	413 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal NN: Unclassifiable	968 Number of hypoglycaemic episodes	879 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal ADA: Severe	5 Number of hypoglycaemic episodes	2 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal ADA: Documented symptomatic	3767 Number of hypoglycaemic episodes	3907 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal ADA: Asymptomatic	750 Number of hypoglycaemic episodes	677 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal ADA: Probable symptomatic	43 Number of hypoglycaemic episodes	17 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal ADA: Pseudo	29 Number of hypoglycaemic episodes	98 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal NN: BG confirmed	1403 Number of hypoglycaemic episodes	1399 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal NN: Severe or BG confirmed symptomatic	1246 Number of hypoglycaemic episodes	1259 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal NN: Severe or BG confirmed	1408 Number of hypoglycaemic episodes	1401 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal NN: Unclassifiable	3186 Number of hypoglycaemic episodes	3300 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal NN: BG confirmed	921 Number of hypoglycaemic episodes	986 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal NN: Severe or BG confirmed symptomatic	805 Number of hypoglycaemic episodes	887 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal NN: Severe or BG confirmed	926 Number of hypoglycaemic episodes	988 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal NN: Unclassifiable	2218 Number of hypoglycaemic episodes	2421 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal ADA: Pseudo	22 Number of hypoglycaemic episodes	64 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal ADA: Severe	5 Number of hypoglycaemic episodes	2 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal ADA: Documented symptomatic	2509 Number of hypoglycaemic episodes	2830 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal ADA: Asymptomatic	574 Number of hypoglycaemic episodes	502 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal ADA: Probable symptomatic	34 Number of hypoglycaemic episodes	11 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal ADA: Severe	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal ADA: Documented symptomatic	1034 Number of hypoglycaemic episodes	887 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal ADA: Asymptomatic	145 Number of hypoglycaemic episodes	142 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal ADA: Probable symptomatic	8 Number of hypoglycaemic episodes	3 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal ADA: Pseudo	7 Number of hypoglycaemic episodes	29 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal NN: BG confirmed	390 Number of hypoglycaemic episodes	362 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal NN: Severe or BG confirmed symptomatic	360 Number of hypoglycaemic episodes	324 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal NN: Severe or BG confirmed	390 Number of hypoglycaemic episodes	362 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal NN: Unclassifiable	804 Number of hypoglycaemic episodes	699 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal ADA: Severe	2 Number of hypoglycaemic episodes	1 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal ADA: Documented symptomatic	1327 Number of hypoglycaemic episodes	1518 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal ADA: Asymptomatic	277 Number of hypoglycaemic episodes	241 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal ADA: Probable symptomatic	19 Number of hypoglycaemic episodes	7 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal ADA: Pseudo	13 Number of hypoglycaemic episodes	38 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal NN: BG confirmed	491 Number of hypoglycaemic episodes	555 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal NN: Severe or BG confirmed symptomatic	429 Number of hypoglycaemic episodes	508 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal NN: Severe or BG confirmed	493 Number of hypoglycaemic episodes	556 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal NN: Unclassifiable	1145 Number of hypoglycaemic episodes	1249 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal ADA: Severe	3 Number of hypoglycaemic episodes	1 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal ADA: Documented symptomatic	1182 Number of hypoglycaemic episodes	1312 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal ADA: Asymptomatic	297 Number of hypoglycaemic episodes	261 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal ADA: Probable symptomatic	15 Number of hypoglycaemic episodes	4 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal ADA: Pseudo	9 Number of hypoglycaemic episodes	26 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal ADA: Unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal NN: BG confirmed	430 Number of hypoglycaemic episodes	431 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal NN: Severe or BG confirmed symptomatic	376 Number of hypoglycaemic episodes	379 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal NN: Severe or BG confirmed	433 Number of hypoglycaemic episodes	432 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal NN: Unclassifiable	1073 Number of hypoglycaemic episodes	1172 Number of hypoglycaemic episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal Not able to selftreat - unclassifiable	0 Number of hypoglycaemic episodes	0 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Weeks 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)	1185 Number of hypoglycaemic episodes	1058 Number of hypoglycaemic episodes

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Physical Examination: Respiratory System Normal, baseline	234 Number of subjects	235 Number of subjects
Change From Baseline in Physical Examination: Respiratory System Abnormal (NCS), baseline	1 Number of subjects	1 Number of subjects
Change From Baseline in Physical Examination: Respiratory System Abnormal (CS), baseline	1 Number of subjects	0 Number of subjects
Change From Baseline in Physical Examination: Respiratory System Normal, last on-treatment value	235 Number of subjects	234 Number of subjects
Change From Baseline in Physical Examination: Respiratory System Abnormal (NCS), last on-treatment value	0 Number of subjects	2 Number of subjects
Change From Baseline in Physical Examination: Respiratory System Abnormal (CS), last on-treatment value	1 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Physical Examination: Cardiovascular System Normal, baseline	233 Number of subjects	229 Number of subjects
Change From Baseline in Physical Examination: Cardiovascular System Abnormal (NCS), baseline	1 Number of subjects	7 Number of subjects
Change From Baseline in Physical Examination: Cardiovascular System Abnormal (CS), baseline	2 Number of subjects	0 Number of subjects
Change From Baseline in Physical Examination: Cardiovascular System Normal, last on-treatment value	231 Number of subjects	228 Number of subjects
Change From Baseline in Physical Examination: Cardiovascular System Abnormal (NCS), last on-treatment value	4 Number of subjects	7 Number of subjects
Change From Baseline in Physical Examination: Cardiovascular System Abnormal (CS), last on-treatment value	1 Number of subjects	1 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Physical Examination: Central and Peripheral Nervous System Normal, baseline	210 Number of subjects	215 Number of subjects
Change From Baseline in Physical Examination: Central and Peripheral Nervous System Abnormal (NCS), baseline	22 Number of subjects	18 Number of subjects
Change From Baseline in Physical Examination: Central and Peripheral Nervous System Abnormal (CS), baseline	4 Number of subjects	3 Number of subjects
Change From Baseline in Physical Examination: Central and Peripheral Nervous System Normal, last on-treatment value	209 Number of subjects	216 Number of subjects
Change From Baseline in Physical Examination: Central and Peripheral Nervous System Abnormal (NCS), last on-treatment value	23 Number of subjects	17 Number of subjects
Change From Baseline in Physical Examination: Central and Peripheral Nervous System Abnormal (CS), last on-treatment value	4 Number of subjects	3 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth Normal, baseline	231 Number of subjects	231 Number of subjects
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth Abnormal (NCS), baseline	3 Number of subjects	5 Number of subjects
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth Abnormal (CS), baseline	2 Number of subjects	0 Number of subjects
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth Normal, last on-treatment value	231 Number of subjects	231 Number of subjects
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth Abnormal (NCS), last on-treatment value	4 Number of subjects	3 Number of subjects
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth Abnormal (CS), last on-treatment value	1 Number of subjects	2 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Physical Examination: Musculoskeletal System Normal, baseline	222 Number of subjects	227 Number of subjects
Change From Baseline in Physical Examination: Musculoskeletal System Abnormal (NCS), baseline	13 Number of subjects	9 Number of subjects
Change From Baseline in Physical Examination: Musculoskeletal System Abnormal (CS), baseline	1 Number of subjects	0 Number of subjects
Change From Baseline in Physical Examination: Musculoskeletal System Normal, last on-treatment value	223 Number of subjects	228 Number of subjects
Change From Baseline in Physical Examination: Musculoskeletal System Abnormal (NCS), last on-treatment value	12 Number of subjects	8 Number of subjects
Change From Baseline in Physical Examination: Musculoskeletal System Abnormal (CS), last on-treatment value	1 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Physical Examination: Skin Normal, baseline	212 Number of subjects	211 Number of subjects
Change From Baseline in Physical Examination: Skin Abnormal (NCS), baseline	18 Number of subjects	22 Number of subjects
Change From Baseline in Physical Examination: Skin Abnormal (CS), baseline	6 Number of subjects	3 Number of subjects
Change From Baseline in Physical Examination: Skin Normal, last on-treatment value	204 Number of subjects	203 Number of subjects
Change From Baseline in Physical Examination: Skin Abnormal (NCS), last on-treatment value	21 Number of subjects	29 Number of subjects
Change From Baseline in Physical Examination: Skin Abnormal (CS), last on-treatment value	11 Number of subjects	4 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck Normal, baseline	219 Number of subjects	221 Number of subjects
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck Abnormal (NCS), baseline	15 Number of subjects	14 Number of subjects
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck Abnormal (CS), baseline	2 Number of subjects	1 Number of subjects
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck Normal, last on-treatment value	217 Number of subjects	218 Number of subjects
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck Abnormal (NCS), last on-treatment value	15 Number of subjects	16 Number of subjects
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck Abnormal (CS), last on-treatment value	4 Number of subjects	2 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Vital Sign: Blood Pressure Systolic blood pressure (baseline)	123.6 mmHg Standard Deviation 14.7	122.0 mmHg Standard Deviation 14.3
Change From Baseline in Vital Sign: Blood Pressure Diastolic blood pressure (baseline)	74.8 mmHg Standard Deviation 9.4	74.6 mmHg Standard Deviation 8.7
Change From Baseline in Vital Sign: Blood Pressure Systolic blood pressure (change from baseline)	-0.8 mmHg Standard Deviation 12.3	-0.7 mmHg Standard Deviation 11.5
Change From Baseline in Vital Sign: Blood Pressure Diastolic blood pressure (change from baseline)	-0.7 mmHg Standard Deviation 8.4	-0.4 mmHg Standard Deviation 7.7

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Vital Sign: Pulse Baseline	73.7 Beats/minute Standard Deviation 11.0	74.5 Beats/minute Standard Deviation 11.1
Change From Baseline in Vital Sign: Pulse Change from baseline	-0.5 Beats/minute Standard Deviation 9.0	-0.8 Beats/minute Standard Deviation 9.6

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Screening in Electrocardiogram (ECG) Normal, screening	178 Number of subjects	181 Number of subjects
Change From Screening in Electrocardiogram (ECG) Abnormal (NCS), screening	58 Number of subjects	54 Number of subjects
Change From Screening in Electrocardiogram (ECG) Abnormal (CS), screening	0 Number of subjects	1 Number of subjects
Change From Screening in Electrocardiogram (ECG) Normal, last on-treatment value	188 Number of subjects	180 Number of subjects
Change From Screening in Electrocardiogram (ECG) Abnormal (NCS), last on-treatment value	44 Number of subjects	48 Number of subjects
Change From Screening in Electrocardiogram (ECG) Abnormal (CS), last on-treatment value	0 Number of subjects	2 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Screening in Fundus Photography/Fundoscopy Left eye (Normal), screening	135 Number of subjects	136 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Left eye (Abnormal [NCS]), screening	94 Number of subjects	94 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Left eye (Abnormal [CS]), screening	7 Number of subjects	6 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Right eye (Normal), screening	132 Number of subjects	132 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Right eye (Abnormal [NCS]), screening	98 Number of subjects	98 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Right eye (Abnormal [CS]), screening	6 Number of subjects	6 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Left eye (Normal), last on-treatment value	130 Number of subjects	119 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Left eye (Abnormal [NCS]), last on-treatment value	77 Number of subjects	82 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Left eye (Abnormal [CS] last on-treatment value	10 Number of subjects	7 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Right eye (Normal), last on-treatment value	127 Number of subjects	114 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Right eye (Abnormal-NCS), last on-treatment value	80 Number of subjects	87 Number of subjects
Change From Screening in Fundus Photography/Fundoscopy Right eye (Abnormal [CS]), last on-treatment value	10 Number of subjects	7 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Haematology: Haemoglobin Baseline	8.62 mmol/L Standard Deviation 0.82	8.62 mmol/L Standard Deviation 0.80
Change From Baseline in Haematology: Haemoglobin Change from baseline	-0.01 mmol/L Standard Deviation 0.48	-0.06 mmol/L Standard Deviation 0.40

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Haematology: Haematocrit Baseline	42.23 % of haematocrit Standard Deviation 3.98	42.37 % of haematocrit Standard Deviation 3.77
Change From Baseline in Haematology: Haematocrit Change from baseline	0.09 % of haematocrit Standard Deviation 2.47	-0.30 % of haematocrit Standard Deviation 2.01

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Haematology: Erythrocytes Baseline	4.66 10^12/L Standard Deviation 0.45	4.72 10^12/L Standard Deviation 0.42
Change From Baseline in Haematology: Erythrocytes Change from baseline	0.01 10^12/L Standard Deviation 0.27	-0.03 10^12/L Standard Deviation 0.22

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Haematology: Thrombocytes Baseline	246.4 10^9/L Standard Deviation 58.9	243.6 10^9/L Standard Deviation 55.3
Change From Baseline in Haematology: Thrombocytes Change from baseline	2.2 10^9/L Standard Deviation 33.5	0.2 10^9/L Standard Deviation 35.8

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Haematology: Leucocytes Baseline	6.41 10^9/L Standard Deviation 1.78	6.32 10^9/L Standard Deviation 1.70
Change From Baseline in Haematology: Leucocytes Change from baseline	-0.09 10^9/L Standard Deviation 1.49	-0.03 10^9/L Standard Deviation 1.22

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Total Protein Baseline	6.73 g/dL Standard Deviation 0.44	6.74 g/dL Standard Deviation 0.47
Change From Baseline in Biochemistry: Total Protein Change from baseline	0.03 g/dL Standard Deviation 0.36	-0.05 g/dL Standard Deviation 0.40

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Creatinine Baseline	73.8 umol/L Standard Deviation 12.3	74.5 umol/L Standard Deviation 13.3
Change From Baseline in Biochemistry: Creatinine Change from baseline	0.9 umol/L Standard Deviation 7.9	-0.1 umol/L Standard Deviation 8.2

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT) Baseline	20.0 U/L Standard Deviation 11.6	19.1 U/L Standard Deviation 11.5
Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT) Change from baseline	0.1 U/L Standard Deviation 13.8	0 U/L Standard Deviation 9.4

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST) Baseline	22.2 U/L Standard Deviation 9.1	20.6 U/L Standard Deviation 7.8
Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST) Change from baseline	-0.1 U/L Standard Deviation 18.6	-0.4 U/L Standard Deviation 8.7

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP) Baseline	68.8 U/L Standard Deviation 20.8	69.7 U/L Standard Deviation 23.9
Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP) Change from baseline	1.2 U/L Standard Deviation 9.6	0.8 U/L Standard Deviation 10.0

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Sodium Baseline	140.3 mmol/L Standard Deviation 2.7	140.3 mmol/L Standard Deviation 2.7
Change From Baseline in Biochemistry: Sodium Change from baseline	-0.2 mmol/L Standard Deviation 2.9	-0.2 mmol/L Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Potassium Baseline	4.34 mmol/L Standard Deviation 0.42	4.30 mmol/L Standard Deviation 0.39
Change From Baseline in Biochemistry: Potassium Change from baseline	-0.02 mmol/L Standard Deviation 0.42	-0.01 mmol/L Standard Deviation 0.41

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Albumin Baseline	4.32 g/dL Standard Deviation 0.27	4.31 g/dL Standard Deviation 0.28
Change From Baseline in Biochemistry: Albumin Change from baseline	-0.01 g/dL Standard Deviation 0.22	-0.05 g/dL Standard Deviation 0.26

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Biochemistry: Total Bilirubin Baseline	8.2 umol/L Standard Deviation 5.1	8.8 umol/L Standard Deviation 6.4
Change From Baseline in Biochemistry: Total Bilirubin Change from baseline	-0.3 umol/L Standard Deviation 3.8	-1.0 umol/L Standard Deviation 3.7

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Urinalysis: Albumin/Creatine Ratio Baseline	2.67 mg/mmol Standard Deviation 13.88	2.00 mg/mmol Standard Deviation 7.60
Change From Baseline in Urinalysis: Albumin/Creatine Ratio Change from baseline	0.01 mg/mmol Standard Deviation 4.76	-0.04 mg/mmol Standard Deviation 3.11

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Urinalysis: Erythrocytes Negative (baseline)	217 Number of subjects	215 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes Trace (baseline)	8 Number of subjects	10 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes 1+ (baseline)	5 Number of subjects	5 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes 2+ (baseline)	5 Number of subjects	1 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes 3+ (baseline)	1 Number of subjects	5 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes Negative (last on-treatment value)	217 Number of subjects	215 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes Trace (last on-treatment value)	6 Number of subjects	10 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes 1+ (last on-treatment value)	3 Number of subjects	3 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes 2+ (last on-treatment value)	2 Number of subjects	4 Number of subjects
Change From Baseline in Urinalysis: Erythrocytes 3+ (last on-treatment value)	8 Number of subjects	4 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Urinalysis: Protein Negative (baseline)	193 Number of subjects	195 Number of subjects
Change From Baseline in Urinalysis: Protein Trace (baseline)	31 Number of subjects	27 Number of subjects
Change From Baseline in Urinalysis: Protein 1+ (baseline)	8 Number of subjects	10 Number of subjects
Change From Baseline in Urinalysis: Protein 2+ (baseline)	4 Number of subjects	4 Number of subjects
Change From Baseline in Urinalysis: Protein 3+ (baseline)	0 Number of subjects	0 Number of subjects
Change From Baseline in Urinalysis: Protein 4+ (baseline)	0 Number of subjects	0 Number of subjects
Change From Baseline in Urinalysis: Protein Negative (last on-treatment value)	196 Number of subjects	196 Number of subjects
Change From Baseline in Urinalysis: Protein Trace (last on-treatment value)	27 Number of subjects	27 Number of subjects
Change From Baseline in Urinalysis: Protein 1+ (last on-treatment value)	10 Number of subjects	9 Number of subjects
Change From Baseline in Urinalysis: Protein 2+ (last on-treatment value)	2 Number of subjects	4 Number of subjects
Change From Baseline in Urinalysis: Protein 3+ (last on-treatment value)	1 Number of subjects	0 Number of subjects
Change From Baseline in Urinalysis: Protein 4+ (last on-treatment value)	0 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Urinalysis: Ketones Negative (baseline)	192 Number of subjects	205 Number of subjects
Change From Baseline in Urinalysis: Ketones Trace (baseline)	31 Number of subjects	23 Number of subjects
Change From Baseline in Urinalysis: Ketones 1+ (baseline)	11 Number of subjects	8 Number of subjects
Change From Baseline in Urinalysis: Ketones 2+ (baseline)	2 Number of subjects	0 Number of subjects
Change From Baseline in Urinalysis: Ketones 3+ (baseline)	0 Number of subjects	0 Number of subjects
Change From Baseline in Urinalysis: Ketones 4+ (baseline)	0 Number of subjects	0 Number of subjects
Change From Baseline in Urinalysis: Ketones Negative (last on-treatment value)	194 Number of subjects	203 Number of subjects
Change From Baseline in Urinalysis: Ketones Trace (last on-treatment value)	25 Number of subjects	27 Number of subjects
Change From Baseline in Urinalysis: Ketones 1+ (last on-treatment value)	15 Number of subjects	5 Number of subjects
Change From Baseline in Urinalysis: Ketones 2+ (last on-treatment value)	2 Number of subjects	1 Number of subjects
Change From Baseline in Urinalysis: Ketones 3+ (last on-treatment value)	0 Number of subjects	0 Number of subjects
Change From Baseline in Urinalysis: Ketones 4+ (last on-treatment value)	0 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Body Weight Baseline	76.86 Kg Standard Deviation 15.20	78.21 Kg Standard Deviation 14.47
Change From Baseline in Body Weight Change from baseline	0.34 Kg Standard Deviation 1.90	0.80 Kg Standard Deviation 2.14

SECONDARY outcome

Timeframe: Week 0, week 16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Change From Baseline in Body Mass Index (BMI) Baseline	26.16 kg/m^2 Standard Deviation 4.06	26.51 kg/m^2 Standard Deviation 3.89
Change From Baseline in Body Mass Index (BMI) Change from baseline	0.12 kg/m^2 Standard Deviation 0.65	0.28 kg/m^2 Standard Deviation 0.74

SECONDARY outcome

Timeframe: Week 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. 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 n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Change-of-infusion-sets Per Week	2.55 Number of infusion-sets Standard Deviation 0.43	2.49 Number of infusion-sets Standard Deviation 0.47

SECONDARY outcome

Timeframe: Week 0-16

Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.

Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Reasons for change-of-infusion-sets are categorised as follows:

Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing

Outcome measures

Measure	Faster Aspart n=236 Participants The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 Participants The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets Category-1	50 Number of subjects	50 Number of subjects
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets Category-2	108 Number of subjects	75 Number of subjects
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets Category-3	23 Number of subjects	17 Number of subjects
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets Category-4	3 Number of subjects	8 Number of subjects
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets Category-5	66 Number of subjects	60 Number of subjects
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets Category-6	16 Number of subjects	8 Number of subjects
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets Category-7	3 Number of subjects	1 Number of subjects

Adverse Events

Faster Aspart

Serious events: 5 serious events

Other events: 84 other events

Deaths: 0 deaths

NovoRapid

Serious events: 8 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	Faster Aspart n=236 participants at risk The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 participants at risk The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 2 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Infections and infestations Adenovirus infection	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Infections and infestations Appendicitis	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Product Issues Device breakage	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Skin and subcutaneous tissue disorders Drug eruption	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Nervous system disorders Hypoglycaemic seizure	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Nervous system disorders Hypoglycaemic unconsciousness	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Metabolism and nutrition disorders Ketoacidosis	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Skin and subcutaneous tissue disorders Neurodermatitis	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
General disorders Non-cardiac chest pain	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Gastrointestinal disorders Oesophagitis	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Surgical and medical procedures Pain management	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Eye disorders Retinal aneurysm	0.00% 0/236 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	0.42% 1/236 • Number of events 1 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.

Other adverse events

Measure	Faster Aspart n=236 participants at risk The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.	NovoRapid n=236 participants at risk The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Infections and infestations Gastroenteritis	5.1% 12/236 • Number of events 12 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	2.5% 6/236 • Number of events 6 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
General disorders Infusion site reaction	6.8% 16/236 • Number of events 26 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	3.0% 7/236 • Number of events 10 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Infections and infestations Upper respiratory tract infection	7.2% 17/236 • Number of events 18 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	5.1% 12/236 • Number of events 12 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.
Infections and infestations Viral upper respiratory tract infection	20.3% 48/236 • Number of events 60 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.	21.2% 50/236 • Number of events 64 • Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.

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