Trial Outcomes & Findings for Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes (NCT NCT04588259)

Results Overview

Change from baseline (week 0) in HbA1c (%) as 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

331 participants

Primary outcome timeframe

Baseline (week 0), week 16

Results posted on

2025-12-04

Participant Flow

The trial was conducted at 31 sites in China.

The trial included an 8-week run-in period and a 16-week treatment period. During the run-in period, participants received NovoRapid both in combination with insulin degludec with or without metformin primarily for optimisation of the basal insulin treatment. Participants were then randomised 1:1 to receive either 'Faster aspart + insulin degludec with or without metformin' or 'NovoRapid + insulin degludec with or without metformin' during the treatment period.

Participant milestones

Participant milestones
Measure	Faster aspart Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Run-in period STARTED	0	331
Run-in period COMPLETED	0	300
Run-in period NOT COMPLETED	0	31
Treatment period STARTED	150	150
Treatment period Full analysis set	150	150
Treatment period Safety analysis set	150	150
Treatment period COMPLETED	144	144
Treatment period NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Faster aspart Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Run-in period Run-in failure	0	23
Run-in period Withdrawn before randomisation	0	8
Treatment period Withdrawal by Subject	6	6

Baseline Characteristics

Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Faster Aspart n=150 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=150 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	Total n=300 Participants Total of all reporting groups
Age, Continuous	56.79 Years STANDARD_DEVIATION 10.65 • n=3 Participants	55.24 Years STANDARD_DEVIATION 12.02 • n=3 Participants	56.02 Years STANDARD_DEVIATION 11.36 • n=6 Participants
Sex: Female, Male Female	68 Participants n=3 Participants	68 Participants n=3 Participants	136 Participants n=6 Participants
Sex: Female, Male Male	82 Participants n=3 Participants	82 Participants n=3 Participants	164 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=3 Participants	150 Participants n=3 Participants	299 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	150 Participants n=3 Participants	150 Participants n=3 Participants	300 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), week 16

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

Change from baseline (week 0) in HbA1c (%) as 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

Outcome measures
Measure	Faster aspart n=143 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=145 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])	-0.57 Percentage of HbA1c Standard Deviation 0.63	-0.54 Percentage of HbA1c Standard Deviation 0.73

PRIMARY outcome

Timeframe: Baseline (week 0), week 16

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.

Change from baseline (week 0) in HbA1c (mmol/mol) 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

Outcome measures
Measure	Faster aspart n=143 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=145 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])	-6.18 mmol/mol Standard Deviation 6.84	-5.89 mmol/mol Standard Deviation 7.94

SECONDARY outcome

Timeframe: Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.

Change from baseline (week 0) in 30-minute, 1-hour, 2-hour and 3-hour PPG increment (meal test) was evaluated at 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The participants were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The participants were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2 and 3 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.

Outcome measures

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=146 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) 30-min	-1.01 Millimoles per litre (mmol/L) Standard Deviation 2.31	0.18 Millimoles per litre (mmol/L) Standard Deviation 2.15
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) 1-hour	-0.94 Millimoles per litre (mmol/L) Standard Deviation 3.08	0.46 Millimoles per litre (mmol/L) Standard Deviation 3.00
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) 2-hour	0.21 Millimoles per litre (mmol/L) Standard Deviation 4.16	0.64 Millimoles per litre (mmol/L) Standard Deviation 4.05
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) 3-hour	0.77 Millimoles per litre (mmol/L) Standard Deviation 4.01	0.65 Millimoles per litre (mmol/L) Standard Deviation 4.55

SECONDARY outcome

Timeframe: Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.

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

Outcome measures

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=146 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) 1-hour	-0.55 mmol/L Standard Deviation 3.53	0.64 mmol/L Standard Deviation 3.10
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) 30-min	-0.64 mmol/L Standard Deviation 3.06	0.37 mmol/L Standard Deviation 2.67
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) 2-hour	0.60 mmol/L Standard Deviation 4.53	0.81 mmol/L Standard Deviation 4.16
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) 3-hour	1.16 mmol/L Standard Deviation 4.41	0.87 mmol/L Standard Deviation 4.55

SECONDARY outcome

Timeframe: Baseline (week 0), week 16

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.

Change from baseline (week 0) in fasting plasma glucose (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

Outcome measures
Measure	Faster aspart n=143 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=145 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in Fasting Plasma Glucose (FPG)	0.39 mmol/L Standard Deviation 2.50	0.20 mmol/L Standard Deviation 2.11

SECONDARY outcome

Timeframe: Baseline (week 0), week 16

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.

Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Outcome measures

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=144 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile	-0.73 mmol/L Standard Deviation 1.55	-0.76 mmol/L Standard Deviation 1.78

SECONDARY outcome

Timeframe: Baseline (week 0), week 16

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.

Change from baseline (week 0) in 1-hour PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Outcome measures

Outcome measures
Measure	Faster aspart n=142 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=140 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) 1 hour after breakfast	-1.01 mmol/L Standard Deviation 2.38	-0.37 mmol/L Standard Deviation 2.85
Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) 1 hour after lunch	-1.16 mmol/L Standard Deviation 2.62	-1.07 mmol/L Standard Deviation 2.65
Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) 1 hour after main evening meal	-1.34 mmol/L Standard Deviation 3.10	-0.68 mmol/L Standard Deviation 2.68
Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) 1 hour after all meals	-1.17 mmol/L Standard Deviation 1.92	-0.70 mmol/L Standard Deviation 2.11

SECONDARY outcome

Timeframe: Baseline (week 0), week 16

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.

Change from baseline (week 0) in PPG increment of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Outcome measures

Outcome measures
Measure	Faster aspart n=141 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=140 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Breakfast	-1.37 mmol/L Standard Deviation 2.37	-0.49 mmol/L Standard Deviation 2.50
Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Lunch	-1.09 mmol/L Standard Deviation 2.89	-0.19 mmol/L Standard Deviation 2.60
Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Main evening meal	-0.34 mmol/L Standard Deviation 2.69	0.15 mmol/L Standard Deviation 2.69
Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) All meals	-0.95 mmol/L Standard Deviation 1.60	-0.22 mmol/L Standard Deviation 1.58

SECONDARY outcome

Timeframe: Baseline (week 0), week 16

Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.

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

Outcome measures

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=144 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Change From Baseline in 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline	0.77 Ratio of 7-9-7-point SMPG Geometric Coefficient of Variation 55.19	0.73 Ratio of 7-9-7-point SMPG Geometric Coefficient of Variation 47.37

SECONDARY outcome

Timeframe: At week 16

Population: FAS which included all randomised participants.

Number of participants who achieved HbA1c \< 7% measured as 53 mmol/mol at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values \< 7% and "No" infers the number of participants who have not achieved HbA1c values \< 7%. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Outcome measures

Outcome measures
Measure	Faster aspart n=150 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=150 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) Yes	59 Participants	55 Participants
Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) No	91 Participants	95 Participants

SECONDARY outcome

Timeframe: At week 16

Population: FAS which included all randomised participants.

Number of participants who achieved HbA1c \< 7% (measured as 53 mmol/mol) without severe hypoglycaemia episodes at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values \< 7% without severe hypoglycaemia episodes and "No" infers the number of participants who have not achieved HbA1c values less than the 7%. without severe hypoglycaemia episodes The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Outcome measures

Outcome measures
Measure	Faster aspart n=150 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=150 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) Yes	59 Participants	55 Participants
Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) No	91 Participants	95 Participants

SECONDARY outcome

Timeframe: At week 16

Population: FAS which included all randomised participants.

Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L measured as 140 milligrams per deciliter (mg/dL) at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Outcome measures

Outcome measures
Measure	Faster aspart n=150 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=150 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L (Yes/No) Yes	61 Participants	51 Participants
Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L (Yes/No) No	89 Participants	99 Participants

SECONDARY outcome

Timeframe: At week 16

Population: FAS which included all randomised participants.

Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L (measured as 140 mg/dL) without severe hypoglycaemia at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Outcome measures

Outcome measures
Measure	Faster aspart n=150 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=150 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L Without Severe Hypoglycaemia (Yes/No) Yes	61 Participants	51 Participants
Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L Without Severe Hypoglycaemia (Yes/No) No	89 Participants	99 Participants

SECONDARY outcome

Timeframe: At week 16

Population: Safety analysis set (SAS) which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.

Total basal insulin dose 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

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=144 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Insulin Dose (Units/Day): Total Basal	27.01 Units/day Standard Deviation 14.37	27.21 Units/day Standard Deviation 13.30

SECONDARY outcome

Timeframe: At week 16

Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.

Total bolus insulin dose 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

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=144 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Insulin Dose (Units/Day): Total Bolus	39.49 Units/day Standard Deviation 17.08	39.16 Units/day Standard Deviation 16.90

SECONDARY outcome

Timeframe: At week 16

Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.

Individual meal time bolus insulin dose for breakast, lunch and main evening meal 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

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=144 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Insulin Dose (Units/Day): Individual Meal Insulin Dose Breakfast	12.00 Units/day Standard Deviation 5.90	11.54 Units/day Standard Deviation 6.12
Insulin Dose (Units/Day): Individual Meal Insulin Dose Lunch	13.67 Units/day Standard Deviation 6.02	13.84 Units/day Standard Deviation 6.11
Insulin Dose (Units/Day): Individual Meal Insulin Dose Main evening meal	13.82 Units/day Standard Deviation 6.38	13.78 Units/day Standard Deviation 5.89

SECONDARY outcome

Timeframe: At week 16

Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.

Total basal insulin dose 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

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=144 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Insulin Dose (Units/kg/Day): Total Basal	0.37 Units/(kilogram) kg/day Standard Deviation 0.19	0.39 Units/(kilogram) kg/day Standard Deviation 0.17

SECONDARY outcome

Timeframe: At week 16

Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.

Total bolus insulin dose 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

Outcome measures
Measure	Faster aspart n=144 Participants Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.	NovoRapid n=144 Participants Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Insulin Dose (Units/kg/Day): Total Bolus	0.56 Units/kg/day Standard Deviation 0.23	0.57 Units/kg/day Standard Deviation 0.25

SECONDARY outcome

Timeframe: At week 16

Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.

Individual meal time bolus insulin dose for breakast, lunch and main evening meal 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.