Trial Outcomes & Findings for Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN

Results Overview

Change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period and 'in trial' observation period. 'On-treatment without rescue medication' observation period: started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. 'In-trial' observation period: started when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

868 participants

Primary outcome timeframe

Week 0, week 30

Results posted on

2021-03-02

Participant Flow

The trial was conducted at 65 sites in 5 countries/regions as follows: Region China: 42 sites; Brazil: 3 sites; Republic of Korea: 12 sites; South Africa: 5 sites; Ukraine: 3 sites.

Participant milestones

Participant milestones
Measure	Semaglutide 0.5 mg Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Overall Study STARTED	288	290	290
Overall Study Exposed	287	290	290
Overall Study Full Analysis Set (FAS)	288	290	290
Overall Study Safety Analysis Set (SAS)	287	290	290
Overall Study COMPLETED	263	262	280
Overall Study NOT COMPLETED	25	28	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide 0.5 mg Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Overall Study Withdrawal by Subject	21	26	9
Overall Study Lost to Follow-up	3	1	1
Overall Study Death	1	1	0

Baseline Characteristics

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide 0.5 mg n=288 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Total n=868 Participants Total of all reporting groups
Age, Continuous	53.0 Years STANDARD_DEVIATION 11.4 • n=5 Participants	53.0 Years STANDARD_DEVIATION 10.6 • n=7 Participants	53.1 Years STANDARD_DEVIATION 10.4 • n=5 Participants	53.1 Years STANDARD_DEVIATION 10.8 • n=4 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	136 Participants n=7 Participants	105 Participants n=5 Participants	369 Participants n=4 Participants
Sex: Female, Male Male	160 Participants n=5 Participants	154 Participants n=7 Participants	185 Participants n=5 Participants	499 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	28 Participants n=7 Participants	30 Participants n=5 Participants	82 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	264 Participants n=5 Participants	262 Participants n=7 Participants	260 Participants n=5 Participants	786 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	243 Participants n=5 Participants	251 Participants n=7 Participants	244 Participants n=5 Participants	738 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	28 Participants n=7 Participants	31 Participants n=5 Participants	89 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants."Number Analyzed" = participants with available data.

Change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period and 'in trial' observation period. 'On-treatment without rescue medication' observation period: started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. 'In-trial' observation period: started when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=288 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in HbA1c On-treatment without rescue medication obs. period	-1.5 Percentage of glycosylated haemoglobin Standard Deviation 1.1	-1.8 Percentage of glycosylated haemoglobin Standard Deviation 0.9	-1.0 Percentage of glycosylated haemoglobin Standard Deviation 0.9
Change in HbA1c In-trial observation period	-1.5 Percentage of glycosylated haemoglobin Standard Deviation 1.1	-1.7 Percentage of glycosylated haemoglobin Standard Deviation 1.0	-0.9 Percentage of glycosylated haemoglobin Standard Deviation 0.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change from baseline (week 0) to week 30 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=253 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Body Weight	-3.0 Kilogram (kg) Standard Deviation 3.8	-4.2 Kilogram (kg) Standard Deviation 3.7	-0.4 Kilogram (kg) Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change from baseline (week 0) to week 30 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=237 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=253 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting Plasma Glucose (FPG)	-2.18 Millimoles per liter (mmol/L) Standard Deviation 2.5	-2.62 Millimoles per liter (mmol/L) Standard Deviation 2.13	-1.0 Millimoles per liter (mmol/L) Standard Deviation 1.74

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change from baseline (week 0) to week 30 in SMPG mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=236 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=251 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile	-2.5 Millimoles per liter (mmol/L) Standard Deviation 2.4	-3.3 Millimoles per liter (mmol/L) Standard Deviation 2.2	-1.6 Millimoles per liter (mmol/L) Standard Deviation 2.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change from baseline (week 0) to week 30 in SMPG mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=234 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=237 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=251 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals	-1.0 Millimoles per liter (mmol/L) Standard Deviation 2.2	-1.2 Millimoles per liter (mmol/L) Standard Deviation 2.1	-0.7 Millimoles per liter (mmol/L) Standard Deviation 2.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in fasting insulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting insulin was measured in picomoles per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=229 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=237 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=254 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting Insulin - Ratio to Baseline	1.06 Ratio of fasting insulin Geometric Coefficient of Variation 46.6	1.03 Ratio of fasting insulin Geometric Coefficient of Variation 51.2	1.01 Ratio of fasting insulin Geometric Coefficient of Variation 41.6

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change in fasting C-peptide from baseline (week 0) to week 30 is presented as ratio to baseline. C-peptide was measured in nanomoles per liter (nmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=234 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=254 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting C-peptide - Ratio to Baseline	1.08 Ratio of fasting C-peptide Geometric Coefficient of Variation 30.3	1.05 Ratio of fasting C-peptide Geometric Coefficient of Variation 32.4	1.0 Ratio of fasting C-peptide Geometric Coefficient of Variation 32.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change in fasting glucagon from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting glucagon was measured in picogram per mililiter (pg/mL). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=205 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=206 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=221 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting Glucagon - Ratio to Baseline	0.89 Ratio of fasting glucagon Geometric Coefficient of Variation 32.4	0.89 Ratio of fasting glucagon Geometric Coefficient of Variation 28.1	0.93 Ratio of fasting glucagon Geometric Coefficient of Variation 25.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change in fasting proinsulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting proinsulin was measured in picomole per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=234 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=241 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=253 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting Proinsulin - Ratio to Baseline	0.68 Ratio of fasting proinsulin Geometric Coefficient of Variation 62.7	0.59 Ratio of fasting proinsulin Geometric Coefficient of Variation 65.3	0.81 Ratio of fasting proinsulin Geometric Coefficient of Variation 58.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in fasting proinsulin/insulin ratio from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=226 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=237 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=253 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline	0.63 Ratio of fasting proinsulin/insulin Geometric Coefficient of Variation 50.2	0.57 Ratio of fasting proinsulin/insulin Geometric Coefficient of Variation 52.1	0.80 Ratio of fasting proinsulin/insulin Geometric Coefficient of Variation 45.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change in fasting HOMA-B (homeostasis model assessment beta-cell function) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=228 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=236 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=252 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline	1.81 Ratio of fasting HOMA-B Geometric Coefficient of Variation 57.3	1.95 Ratio of fasting HOMA-B Geometric Coefficient of Variation 59.1	1.25 Ratio of fasting HOMA-B Geometric Coefficient of Variation 46.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change in fasting HOMA-IR (homeostasis model assessment insulin resistence) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=228 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=236 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=252 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline	0.81 Ratio of fasting HOMA-IR Geometric Coefficient of Variation 60.9	0.74 Ratio of fasting HOMA-IR Geometric Coefficient of Variation 63.2	0.90 Ratio of fasting HOMA-IR Geometric Coefficient of Variation 52.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Short Form (SF)-36 is a 36-item patient-reported survey that measures patient's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured 8 domains of functional health \& well-being and 2 component summary scores (physical component summary-PCS and mental component summary-MCS). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 30. A positive change score indicates an improvement since baseline. Results are based on the data from the 'on-treatment without rescue medication' observation period.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=246 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=249 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=257 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Physical component summary (PCS)	1.3 Score on a scale Standard Deviation 5.9	1.1 Score on a scale Standard Deviation 6.0	0.0 Score on a scale Standard Deviation 5.8
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Physical functioning	0.6 Score on a scale Standard Deviation 5.6	0.9 Score on a scale Standard Deviation 7.4	-0.3 Score on a scale Standard Deviation 5.5
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Role-physical	1.4 Score on a scale Standard Deviation 7.6	0.2 Score on a scale Standard Deviation 6.9	-0.0 Score on a scale Standard Deviation 7.0
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Bodily pain	0.6 Score on a scale Standard Deviation 8.4	0.4 Score on a scale Standard Deviation 9.9	0.0 Score on a scale Standard Deviation 9.8
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score General health	3.3 Score on a scale Standard Deviation 8.8	2.9 Score on a scale Standard Deviation 9.4	2.2 Score on a scale Standard Deviation 9.0
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Mental component summary (MCS)	1.2 Score on a scale Standard Deviation 8.0	0.5 Score on a scale Standard Deviation 8.4	1.5 Score on a scale Standard Deviation 7.7
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Social functioning	1.3 Score on a scale Standard Deviation 7.0	-0.4 Score on a scale Standard Deviation 7.8	0.8 Score on a scale Standard Deviation 7.6
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Role-emotional	1.3 Score on a scale Standard Deviation 8.5	0.9 Score on a scale Standard Deviation 8.9	1.0 Score on a scale Standard Deviation 8.6
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Vitality	1.2 Score on a scale Standard Deviation 9.8	1.4 Score on a scale Standard Deviation 10.1	1.1 Score on a scale Standard Deviation 9.1
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score Mental health	0.9 Score on a scale Standard Deviation 8.7	0.4 Score on a scale Standard Deviation 9.1	1.1 Score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire (DTSQs) was evaluated at week 30. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 3 -8. For items 1 and 2 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 1) or low (item 2). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 3-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=246 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=249 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=257 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Patient Reported Outcome Questionnaire: DTSQs Score 1) Feeling of unacceptably high blood sugars	-1.4 Score on a scale Standard Deviation 2.2	-1.6 Score on a scale Standard Deviation 2.2	-1.0 Score on a scale Standard Deviation 2.2
Change in Patient Reported Outcome Questionnaire: DTSQs Score 2) Feeling of unacceptably low blood sugars	-0.1 Score on a scale Standard Deviation 1.9	-0.3 Score on a scale Standard Deviation 2.0	-0.1 Score on a scale Standard Deviation 1.7
Change in Patient Reported Outcome Questionnaire: DTSQs Score 3) Satisfaction with treatment	1.1 Score on a scale Standard Deviation 1.8	1.3 Score on a scale Standard Deviation 1.7	0.7 Score on a scale Standard Deviation 1.7
Change in Patient Reported Outcome Questionnaire: DTSQs Score 4) Convenience of treatment	0.7 Score on a scale Standard Deviation 1.6	0.7 Score on a scale Standard Deviation 1.5	0.5 Score on a scale Standard Deviation 1.8
Change in Patient Reported Outcome Questionnaire: DTSQs Score 5) Flexibility of current treatment	0.7 Score on a scale Standard Deviation 1.6	0.8 Score on a scale Standard Deviation 1.4	0.4 Score on a scale Standard Deviation 1.5
Change in Patient Reported Outcome Questionnaire: DTSQs Score 6) Satisfaction with understanding of diabetes	0.9 Score on a scale Standard Deviation 1.7	0.8 Score on a scale Standard Deviation 1.5	0.7 Score on a scale Standard Deviation 1.8
Change in Patient Reported Outcome Questionnaire: DTSQs Score 7) Recommending treatment to others	0.9 Score on a scale Standard Deviation 1.8	0.9 Score on a scale Standard Deviation 1.6	0.7 Score on a scale Standard Deviation 1.7
Change in Patient Reported Outcome Questionnaire: DTSQs Score 8) Satisfaction to continue with present treatment	0.7 Score on a scale Standard Deviation 1.6	0.7 Score on a scale Standard Deviation 1.6	0.6 Score on a scale Standard Deviation 1.6
Change in Patient Reported Outcome Questionnaire: DTSQs Score Total Diabetic Treatment Satisfaction score	4.9 Score on a scale Standard Deviation 7.2	5.1 Score on a scale Standard Deviation 6.3	3.7 Score on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change in high-sensitivity C-reactive protein (CRP) from baseline (week 0) to week 30 is presented as ratio to baseline. High-sensitivity CRP was measured in mg/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=240 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=252 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in High-sensitivity CRP - Ratio to Baseline	0.73 Ratio of high-sensitivity CRP Geometric Coefficient of Variation 121.2	0.64 Ratio of high-sensitivity CRP Geometric Coefficient of Variation 108.6	0.96 Ratio of high-sensitivity CRP Geometric Coefficient of Variation 128.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in waist circumference from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=254 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Waist Circumference	-2.7 Centimeter (cm) Standard Deviation 5.0	-4.0 Centimeter (cm) Standard Deviation 4.8	-0.7 Centimeter (cm) Standard Deviation 4.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in body mass index (BMI) from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=253 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in BMI	-1.1 Kilogram per square meter (kg/m^2) Standard Deviation 1.4	-1.6 Kilogram per square meter (kg/m^2) Standard Deviation 1.4	-0.1 Kilogram per square meter (kg/m^2) Standard Deviation 0.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in fasting total cholesterol from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting total cholesterol was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=240 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=252 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting Total Cholesterol - Ratio to Baseline	0.95 Ratio of fasting total cholesterol Geometric Coefficient of Variation 20.2	0.95 Ratio of fasting total cholesterol Geometric Coefficient of Variation 17.7	1.00 Ratio of fasting total cholesterol Geometric Coefficient of Variation 16.8

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in fasting low density lipoprotein (LDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting LDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=237 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=240 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=250 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting LDL Cholesterol - Ratio to Baseline	0.97 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 33.2	0.99 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 31.6	1.01 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 26.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in fasting very low density lipoprotein (VLDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting VLDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=237 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=240 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=251 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting VLDL Cholesterol - Ratio to Baseline	0.86 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 44.8	0.82 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 38.8	0.93 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 46.3

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in fasting high density lipoprotein (HDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting HDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=240 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=251 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting HDL Cholesterol - Ratio to Baseline	1.00 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 15.8	1.02 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 16.3	1.01 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 14.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change in fasting triglycerides from baseline (week 0) to week 30 is presented as ratio to baseline. Triglycerides was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=237 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=240 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=251 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Fasting Triglycerides - Ratio to Baseline	0.86 Ratio of fasting triglycerides Geometric Coefficient of Variation 47.5	0.81 Ratio of fasting triglycerides Geometric Coefficient of Variation 41.9	0.93 Ratio of fasting triglycerides Geometric Coefficient of Variation 49.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data.

Change in free fatty acids from baseline (week 0) to week 30 is presented as ratio to baseline. Free fatty acids was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=231 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=254 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Free Fatty Acids - Ratio to Baseline	0.78 Ratio of free fatty acids Geometric Coefficient of Variation 70.4	0.78 Ratio of free fatty acids Geometric Coefficient of Variation 65.8	0.87 Ratio of free fatty acids Geometric Coefficient of Variation 61.8

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Change from baseline (week 0) to week 30 in systolic blood pressure and diastolic blood pressure were evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=254 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Systolic blood pressure	-3.4 Millimeters of mercury (mmHg) Standard Deviation 14.7	-6.5 Millimeters of mercury (mmHg) Standard Deviation 13.4	-0.9 Millimeters of mercury (mmHg) Standard Deviation 13.6
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Diastolic blood pressure	-0.7 Millimeters of mercury (mmHg) Standard Deviation 9.4	-1.5 Millimeters of mercury (mmHg) Standard Deviation 8.7	-0.8 Millimeters of mercury (mmHg) Standard Deviation 8.5

SECONDARY outcome

Timeframe: Week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Percentage of participants who achieved HbA1c \< 7.0% (53 millimoles per mole \[mmol/mol\]), American Diabetes Association (ADA) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=250 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) Yes	74.5 Percentage of participants	84.0 Percentage of participants	49.6 Percentage of participants
Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) No	25.5 Percentage of participants	16.0 Percentage of participants	50.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Percentage of participants who achieved HbA1c ≤6.5% (48 millimoles per mole \[mmol/mol\]), American Association of Clinical Endocrinologists (AACE) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=250 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) Yes	60.4 Percentage of participants	70.6 Percentage of participants	31.6 Percentage of participants
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) No	39.6 Percentage of participants	29.4 Percentage of participants	68.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter \[mg/dL\]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=249 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain Yes	66.0 Percentage of participants	76.9 Percentage of participants	33.7 Percentage of participants
Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain No	34.0 Percentage of participants	23.1 Percentage of participants	66.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=253 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% Yes	36.6 Percentage of participants	52.7 Percentage of participants	5.9 Percentage of participants
Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% No	63.4 Percentage of participants	47.3 Percentage of participants	94.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 30

Population: Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data.

Percentage of participants losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=253 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% Yes	9.7 Percentage of participants	17.2 Percentage of participants	0.4 Percentage of participants
Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% No	90.3 Percentage of participants	82.8 Percentage of participants	99.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 0 to week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.

A treatment emergent adverse event (TEAE) is defined as an adverse event with onset in the on-treatment observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=287 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Total Number of Treatment Emergent Adverse Events	729 Events	788 Events	596 Events

SECONDARY outcome

Timeframe: Week 0 to week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.

Hypoglycaemic episodes are defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=287 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes	3 Episodes	7 Episodes	5 Episodes

SECONDARY outcome

Timeframe: Week 0 to week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.

Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=287 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes	2 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in haemoglobin from baseline (week 0) to week 30 is presented as ratio to baseline. Haemoglobin was measured in mmol/L. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Haematological Parameter: Haemoglobin - Ratio to Baseline	1.00 Ratio of haemoglobin Geometric Coefficient of Variation 6.0	1.00 Ratio of haemoglobin Geometric Coefficient of Variation 5.6	1.00 Ratio of haemoglobin Geometric Coefficient of Variation 5.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in haematocrit from baseline (week 0) to week 30 is presented as ratio to baseline. Haematocrit was measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Haematological Parameter: Haematocrit - Ratio to Baseline	1.00 Ratio of haematocrit Geometric Coefficient of Variation 6.3	1.00 Ratio of haematocrit Geometric Coefficient of Variation 6.3	1.00 Ratio of haematocrit Geometric Coefficient of Variation 6.3

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in thrombocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Thrombocytes was measured in 10\^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=233 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter: Thrombocytes - Ratio to Baseline	1.01 Ratio of thrombocytes Geometric Coefficient of Variation 21.3	1.01 Ratio of thrombocytes Geometric Coefficient of Variation 21.2	0.99 Ratio of thrombocytes Geometric Coefficient of Variation 17.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in erythrocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Erythrocytes were measured in 10\^12 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter: Erythrocytes - Ratio to Baseline	0.99 Ratio of erythrocytes Geometric Coefficient of Variation 5.6	0.99 Ratio of erythrocytes Geometric Coefficient of Variation 5.4	0.99 Ratio of erythrocytes Geometric Coefficient of Variation 5.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in leukocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Leukocytes were measured in 10\^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter: Leukocytes - Ratio to Baseline	1.03 Ratio of leukocytes Geometric Coefficient of Variation 21.1	1.01 Ratio of leukocytes Geometric Coefficient of Variation 23.7	1.08 Ratio of leukocytes Geometric Coefficient of Variation 24.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in basophils from baseline (week 0) to week 30 is presented as ratio to baseline. Basophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=229 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=230 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=251 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline	0.91 Ratio of basophils Geometric Coefficient of Variation 68.1	0.80 Ratio of basophils Geometric Coefficient of Variation 71.3	0.83 Ratio of basophils Geometric Coefficient of Variation 69.6

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in neutrophils from baseline (week 0) to week 30 is presented as ratio to baseline. Neutrophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline	1.01 Ratio of neutrophils Geometric Coefficient of Variation 12.9	1.02 Ratio of neutrophils Geometric Coefficient of Variation 20.2	1.02 Ratio of neutrophils Geometric Coefficient of Variation 13.7

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in eosinophils from baseline (week 0) to week 30 is presented as ratio to baseline. Eosinophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=238 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=234 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=265 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline	0.98 Ratio of eosinophils Geometric Coefficient of Variation 57.9	1.04 Ratio of eosinophils Geometric Coefficient of Variation 64.7	1.00 Ratio of eosinophils Geometric Coefficient of Variation 65.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in monocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Monocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline	0.96 Ratio of monocytes Geometric Coefficient of Variation 33.7	0.98 Ratio of monocytes Geometric Coefficient of Variation 34.7	1.04 Ratio of monocytes Geometric Coefficient of Variation 36.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in lymphocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Lymphocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=239 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=235 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=266 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline	1.01 Ratio of lymphocytes Geometric Coefficient of Variation 22.7	0.98 Ratio of lymphocytes Geometric Coefficient of Variation 23.6	0.97 Ratio of lymphocytes Geometric Coefficient of Variation 24.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in amylase from baseline (week 0) to week 30 is presented as ratio to baseline. Amylase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Amylase - Ratio to Baseline	1.17 Ratio of amylase Geometric Coefficient of Variation 30.6	1.19 Ratio of amylase Geometric Coefficient of Variation 23.6	1.10 Ratio of amylase Geometric Coefficient of Variation 22.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in lipase from baseline (week 0) to week 30 is presented as ratio to baseline. Lipase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=243 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=273 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Lipase - Ratio to Baseline	1.33 Ratio of lipase Geometric Coefficient of Variation 43.9	1.42 Ratio of lipase Geometric Coefficient of Variation 51.2	1.24 Ratio of lipase Geometric Coefficient of Variation 47.2

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in alkaline phosphatase from baseline (week 0) to week 30 is presented as ratio to baseline. Alkaline phosphatase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline	0.92 Ratio of alkaline phosphatase Geometric Coefficient of Variation 31.3	0.91 Ratio of alkaline phosphatase Geometric Coefficient of Variation 15.3	0.92 Ratio of alkaline phosphatase Geometric Coefficient of Variation 20.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in alanine aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Alanine aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=246 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=241 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=269 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline	0.86 Ratio of alanine aminotransferase Geometric Coefficient of Variation 55.7	0.83 Ratio of alanine aminotransferase Geometric Coefficient of Variation 47.1	0.95 Ratio of alanine aminotransferase Geometric Coefficient of Variation 35.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed "= participants with available data.

Change in aspartate aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Aspartate aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=246 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=268 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline	0.92 Ratio of aspartate aminotransferase Geometric Coefficient of Variation 36.9	0.88 Ratio of aspartate aminotransferase Geometric Coefficient of Variation 36.7	0.99 Ratio of aspartate aminotransferase Geometric Coefficient of Variation 29.3

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in total bilirubin from baseline (week 0) to week 30 is presented as ratio to baseline. Total bilirubin was measured in micromoles per liter (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=241 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=269 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline	0.93 Ratio of total bilirubin Geometric Coefficient of Variation 32.8	0.93 Ratio of total bilirubin Geometric Coefficient of Variation 35.4	0.93 Ratio of total bilirubin Geometric Coefficient of Variation 36.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in calcium (corrected) from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline	1.01 Ratio of calcium Geometric Coefficient of Variation 3.7	1.01 Ratio of calcium Geometric Coefficient of Variation 3.2	1.01 Ratio of calcium Geometric Coefficient of Variation 3.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in total calcium from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline	1.02 Ratio of total calcium Geometric Coefficient of Variation 4.4	1.01 Ratio of total calcium Geometric Coefficient of Variation 3.8	1.01 Ratio of total calcium Geometric Coefficient of Variation 3.9

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in potassium from baseline (week 0) to week 30 is presented as ratio to baseline. Potassium was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=246 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Potassium - Ratio to Baseline	1.01 Ratio of potassium Geometric Coefficient of Variation 7.7	1.00 Ratio of potassium Geometric Coefficient of Variation 8.4	1.00 Ratio of potassium Geometric Coefficient of Variation 8.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in sodium from baseline (week 0) to week 30 is presented as ratio to baseline. Sodium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=246 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Sodium - Ratio to Baseline	1.01 Ratio of sodium Geometric Coefficient of Variation 1.5	1.00 Ratio of sodium Geometric Coefficient of Variation 1.5	1.00 Ratio of sodium Geometric Coefficient of Variation 1.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in albumin from baseline (week 0) to week 30 is presented as ratio to baseline. Albumin was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Albumin - Ratio to Baseline	1.02 Ratio of albumin Geometric Coefficient of Variation 5.4	1.02 Ratio of albumin Geometric Coefficient of Variation 5.4	1.01 Ratio of albumin Geometric Coefficient of Variation 4.8

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in creatine kinase from baseline (week 0) to week 30 is presented as ratio to baseline. Creatine kinase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=270 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline	1.02 Ratio of creatine kinase Geometric Coefficient of Variation 49.1	0.96 Ratio of creatine kinase Geometric Coefficient of Variation 41.8	1.07 Ratio of creatine kinase Geometric Coefficient of Variation 43.5

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in Total protein from baseline (week 0) to week 30 is presented as ratio to baseline. Total Protein was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=242 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=271 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Total Protein- Ratio to Baseline	1.01 Ratio of total protein Geometric Coefficient of Variation 5.0	1.00 Ratio of total protein Geometric Coefficient of Variation 5.3	1.01 Ratio of total protein Geometric Coefficient of Variation 5.2

SECONDARY outcome

Timeframe: Week -2, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in creatinine from baseline (week -2) to week 30 is presented as ratio to baseline. Creatinine was measured in micromoles per lier (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=243 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=273 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Creatinine - Ratio to Baseline	1.08 Ratio of creatinine Geometric Coefficient of Variation 12.6	1.07 Ratio of creatinine Geometric Coefficient of Variation 11.7	1.05 Ratio of creatinine Geometric Coefficient of Variation 12.1

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in urea from baseline (week 0) to week 30 is presented as ratio to baseline. Urea was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=243 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=273 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Urea - Ratio to Baseline	1.01 Ratio of urea Geometric Coefficient of Variation 25.6	1.02 Ratio of urea Geometric Coefficient of Variation 26.4	1.01 Ratio of urea Geometric Coefficient of Variation 23.6

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in estimated glomerular filtration rate (eGFR) from baseline (week 0) to week 30 is presented as ratio to baseline. Glomerular filtration rate was measured in milliliter/minute/specific surface area (mL/min/SSA). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=243 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=273 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline	0.92 Ratio of eGFR Geometric Coefficient of Variation 14.6	0.92 Ratio of eGFR Geometric Coefficient of Variation 13.6	0.94 Ratio of eGFR Geometric Coefficient of Variation 14.0

SECONDARY outcome

Timeframe: Week -2, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Change in calcitonin from baseline (week -2) to week 30 is presented as ratio to baseline. Calcitonin was measured in nanogram per liter (ng/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=246 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=244 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=273 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Calcitonin - Ratio to Baseline	0.96 Ratio of calcitonin Geometric Coefficient of Variation 37.5	1.00 Ratio of calcitonin Geometric Coefficient of Variation 44.8	0.96 Ratio of calcitonin Geometric Coefficient of Variation 48.4

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed"=participants with available data.

Change in urin albumin to creatinine ratio (UACR) from baseline (week 0) to week 30 is presented as ratio to baseline. UACR was measured in milligram/millimole (mg/mmol). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=155 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=164 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=189 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Urinalysis Parameter - UACR-ratio to Baseline	0.77 Ratio of UACR Geometric Coefficient of Variation 83.5	0.69 Ratio of UACR Geometric Coefficient of Variation 78.4	0.89 Ratio of UACR Geometric Coefficient of Variation 76.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Glucose in urine was assessed by the investigator and categorised as negative, \[100-249\], \[250-499\], \[500-999\] and \>= 1000. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=286 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=289 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=287 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Urinalysis Parameter: Glucose At week 0 · Negative	189 Participants	187 Participants	176 Participants
Change in Urinalysis Parameter: Glucose At week 0 · 100-249	28 Participants	27 Participants	42 Participants
Change in Urinalysis Parameter: Glucose At week 0 · 250-499	12 Participants	20 Participants	25 Participants
Change in Urinalysis Parameter: Glucose At week 0 · 500-999	20 Participants	25 Participants	21 Participants
Change in Urinalysis Parameter: Glucose At week 0 · >= 1000	37 Participants	30 Participants	23 Participants
Change in Urinalysis Parameter: Glucose At week 30 · Negative	244 Participants	258 Participants	233 Participants
Change in Urinalysis Parameter: Glucose At week 30 · 100-249	7 Participants	15 Participants	23 Participants
Change in Urinalysis Parameter: Glucose At week 30 · 250-499	10 Participants	5 Participants	5 Participants
Change in Urinalysis Parameter: Glucose At week 30 · 500-999	11 Participants	4 Participants	12 Participants
Change in Urinalysis Parameter: Glucose At week 30 · >= 1000	14 Participants	7 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

pH in urine was assessed by the investigator and categorised as 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, \>=9. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=286 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=289 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=287 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Urinalysis Parameter: pH At week 0 · 5	0 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: pH At week 0 · 5.5	17 Participants	15 Participants	14 Participants
Change in Urinalysis Parameter: pH At week 0 · 6	220 Participants	214 Participants	222 Participants
Change in Urinalysis Parameter: pH At week 0 · 6.5	31 Participants	40 Participants	33 Participants
Change in Urinalysis Parameter: pH At week 0 · 7	13 Participants	14 Participants	15 Participants
Change in Urinalysis Parameter: pH At week 0 · 7.5	3 Participants	4 Participants	1 Participants
Change in Urinalysis Parameter: pH At week 0 · 8	0 Participants	2 Participants	1 Participants
Change in Urinalysis Parameter: pH At week 0 · 8.5	1 Participants	0 Participants	1 Participants
Change in Urinalysis Parameter: pH At week 0 · >= 9	1 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: pH At week 30 · 5	0 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: pH At week 30 · 5.5	16 Participants	21 Participants	30 Participants
Change in Urinalysis Parameter: pH At week 30 · 6	209 Participants	194 Participants	201 Participants
Change in Urinalysis Parameter: pH At week 30 · 6.5	33 Participants	40 Participants	24 Participants
Change in Urinalysis Parameter: pH At week 30 · 7	24 Participants	30 Participants	22 Participants
Change in Urinalysis Parameter: pH At week 30 · 7.5	2 Participants	3 Participants	5 Participants
Change in Urinalysis Parameter: pH At week 30 · 8	1 Participants	1 Participants	5 Participants
Change in Urinalysis Parameter: pH At week 30 · 8.5	1 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: pH At week 30 · >= 9	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Protein in urine was assessed by the investigator and categorised as negative, trace, 30-99, 100-299, Approximately 300, \>=300. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=286 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=289 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=287 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Urinalysis Parameter: Protein At week 0 · Negative	231 Participants	233 Participants	235 Participants
Change in Urinalysis Parameter: Protein At week 0 · Trace	31 Participants	32 Participants	30 Participants
Change in Urinalysis Parameter: Protein At week 0 · 30-99	17 Participants	18 Participants	15 Participants
Change in Urinalysis Parameter: Protein At week 0 · 100-299	6 Participants	4 Participants	6 Participants
Change in Urinalysis Parameter: Protein At week 0 · Approximately 300	0 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: Protein At week 0 · >=300	1 Participants	2 Participants	1 Participants
Change in Urinalysis Parameter: Protein At week 30 · Negative	247 Participants	248 Participants	239 Participants
Change in Urinalysis Parameter: Protein At week 30 · Trace	22 Participants	28 Participants	24 Participants
Change in Urinalysis Parameter: Protein At week 30 · 30-99	13 Participants	9 Participants	12 Participants
Change in Urinalysis Parameter: Protein At week 30 · 100-299	4 Participants	4 Participants	11 Participants
Change in Urinalysis Parameter: Protein At week 30 · Approximately 300	0 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: Protein At week 30 · >=300	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Ketones in urine was assessed by the investigator and categorised as negative, trace, 15-39, 40-79, Approximately 80, \>= 80. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=286 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=289 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=287 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Urinalysis Parameter: Ketones At week 0 · Negative	267 Participants	268 Participants	274 Participants
Change in Urinalysis Parameter: Ketones At week 0 · Trace	11 Participants	17 Participants	9 Participants
Change in Urinalysis Parameter: Ketones At week 0 · 15-39	8 Participants	3 Participants	3 Participants
Change in Urinalysis Parameter: Ketones At week 0 · 40- 79	0 Participants	1 Participants	0 Participants
Change in Urinalysis Parameter: Ketones At week 0 · Approximately 80	0 Participants	0 Participants	1 Participants
Change in Urinalysis Parameter: Ketones At week 0 · >=80	0 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: Ketones At week 30 · Negative	268 Participants	274 Participants	274 Participants
Change in Urinalysis Parameter: Ketones At week 30 · Trace	12 Participants	12 Participants	11 Participants
Change in Urinalysis Parameter: Ketones At week 30 · 15-39	6 Participants	3 Participants	1 Participants
Change in Urinalysis Parameter: Ketones At week 30 · 40- 79	0 Participants	0 Participants	1 Participants
Change in Urinalysis Parameter: Ketones At week 30 · Approximately 80	0 Participants	0 Participants	0 Participants
Change in Urinalysis Parameter: Ketones At week 30 · >=80	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

Erythrocytes in urine was assessed by the investigator and categorised as negative, trace, small, moderate, large. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=286 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=289 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=287 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Urinalysis Parameter: Erythrocytes At week 30 · Moderate	2 Participants	6 Participants	1 Participants
Change in Urinalysis Parameter: Erythrocytes At week 30 · Large	4 Participants	6 Participants	3 Participants
Change in Urinalysis Parameter: Erythrocytes At week 0 · Negative	251 Participants	250 Participants	253 Participants
Change in Urinalysis Parameter: Erythrocytes At week 0 · Trace	25 Participants	20 Participants	19 Participants
Change in Urinalysis Parameter: Erythrocytes At week 0 · Small	5 Participants	8 Participants	9 Participants
Change in Urinalysis Parameter: Erythrocytes At week 0 · Moderate	1 Participants	3 Participants	3 Participants
Change in Urinalysis Parameter: Erythrocytes At week 0 · Large	4 Participants	8 Participants	3 Participants
Change in Urinalysis Parameter: Erythrocytes At week 30 · Negative	258 Participants	259 Participants	252 Participants
Change in Urinalysis Parameter: Erythrocytes At week 30 · Trace	18 Participants	13 Participants	22 Participants
Change in Urinalysis Parameter: Erythrocytes At week 30 · Small	4 Participants	5 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed"=participants with available data.

Change in pulse from baseline (week 0) to week 30 is presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=247 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=243 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=273 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Clinical Evaluation: Pulse	3.7 Beats per minute (beats/min) Standard Deviation 10.1	3.7 Beats per minute (beats/min) Standard Deviation 9.4	0.2 Beats per minute (beats/min) Standard Deviation 9.0

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Number Analyzed" = participants with available data.

The electrocardiogram (ECG) was assessed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each ECG category at baseline and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=286 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Clinical Evaluation: ECG At week 0 · Normal	191 Participants	196 Participants	185 Participants
Change in Clinical Evaluation: ECG At week 0 · Abnormal, NCS	72 Participants	68 Participants	76 Participants
Change in Clinical Evaluation: ECG At week 0 · Abnormal, CS	23 Participants	26 Participants	29 Participants
Change in Clinical Evaluation: ECG At week 30 · Normal	162 Participants	172 Participants	167 Participants
Change in Clinical Evaluation: ECG At week 30 · Abnormal, NCS	81 Participants	74 Participants	85 Participants
Change in Clinical Evaluation: ECG At week 30 · Abnormal, CS	19 Participants	18 Participants	26 Participants

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Number Analyzed" = participants with available data.

Eye examination was performed by the investigator and the results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline (week 0) and at week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=286 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Clinical Evaluation: Eye Examinations At week 0, Left eye · Normal	202 Participants	222 Participants	202 Participants
Change in Clinical Evaluation: Eye Examinations At week 0, Left eye · Abnormal, NCS	40 Participants	32 Participants	47 Participants
Change in Clinical Evaluation: Eye Examinations At week 0, Left eye · Abnormal, CS	44 Participants	36 Participants	41 Participants
Change in Clinical Evaluation: Eye Examinations At week 30, Left eye · Normal	162 Participants	184 Participants	174 Participants
Change in Clinical Evaluation: Eye Examinations At week 30, Left eye · Abnormal, NCS	26 Participants	18 Participants	32 Participants
Change in Clinical Evaluation: Eye Examinations At week 30, Left eye · Abnormal, CS	42 Participants	31 Participants	41 Participants
Change in Clinical Evaluation: Eye Examinations At week 0, Right eye · Normal	210 Participants	222 Participants	201 Participants
Change in Clinical Evaluation: Eye Examinations At week 0, Right eye · Abnormal, NCS	37 Participants	31 Participants	47 Participants
Change in Clinical Evaluation: Eye Examinations At week 0, Right eye · Abnormal, CS	39 Participants	37 Participants	42 Participants
Change in Clinical Evaluation: Eye Examinations At week 52, Right eye · Normal	161 Participants	180 Participants	172 Participants
Change in Clinical Evaluation: Eye Examinations At week 52, Right eye · Abnormal, NCS	27 Participants	19 Participants	31 Participants
Change in Clinical Evaluation: Eye Examinations At week 52, Right eye · Abnormal, CS	42 Participants	34 Participants	43 Participants

SECONDARY outcome

Timeframe: Week -2, week 30

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Number Analyzed" = participants with available data.

Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=287 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 Participants Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Change in Physical Examination At week -2, General Appearance · Normal	282 Participants	283 Participants	281 Participants
Change in Physical Examination At week -2, General Appearance · Abnormal, NCS	3 Participants	7 Participants	8 Participants
Change in Physical Examination At week -2, General Appearance · Abnormal, CS	2 Participants	0 Participants	1 Participants
Change in Physical Examination At week 30, General Appearance · Normal	252 Participants	250 Participants	270 Participants
Change in Physical Examination At week 30, General Appearance · Abnormal, NCS	3 Participants	3 Participants	5 Participants
Change in Physical Examination At week 30, General Appearance · Abnormal, CS	1 Participants	0 Participants	1 Participants
Change in Physical Examination At week -2, Nervous System · Normal	277 Participants	287 Participants	279 Participants
Change in Physical Examination At week -2, Nervous System · Abnormal, NCS	5 Participants	1 Participants	8 Participants
Change in Physical Examination At week -2, Nervous System · Abnormal, CS	5 Participants	2 Participants	3 Participants
Change in Physical Examination At week 30, Nervous System · Normal	247 Participants	250 Participants	268 Participants
Change in Physical Examination At week 30, Nervous System · Abnormal, NCS	4 Participants	1 Participants	5 Participants
Change in Physical Examination At week 30, Nervous System · Abnormal, CS	5 Participants	2 Participants	3 Participants
Change in Physical Examination At week -2, Cardiovascular System · Normal	276 Participants	281 Participants	278 Participants
Change in Physical Examination At week -2, Cardiovascular System · Abnormal, NCS	9 Participants	6 Participants	10 Participants
Change in Physical Examination At week -2, Cardiovascular System · Abnormal, CS	2 Participants	3 Participants	2 Participants
Change in Physical Examination At week 30, Cardiovascular System · Normal	245 Participants	246 Participants	265 Participants
Change in Physical Examination At week 30, Cardiovascular System · Abnormal, NCS	8 Participants	4 Participants	10 Participants
Change in Physical Examination At week 30, Cardiovascular System · Abnormal, CS	3 Participants	3 Participants	1 Participants
Change in Physical Examination At week -2, Gastrointestinal System · Normal	280 Participants	285 Participants	280 Participants
Change in Physical Examination At week -2, Gastrointestinal System · Abnormal, NCS	6 Participants	5 Participants	10 Participants
Change in Physical Examination At week -2, Gastrointestinal System · Abnormal, CS	1 Participants	0 Participants	0 Participants
Change in Physical Examination At week 30, Gastrointestinal System · Normal	251 Participants	250 Participants	264 Participants
Change in Physical Examination At week 30, Gastrointestinal System · Abnormal, NCS	5 Participants	2 Participants	11 Participants
Change in Physical Examination At week 30, Gastrointestinal System · Abnormal, CS	0 Participants	1 Participants	1 Participants
Change in Physical Examination At week -2, Musculoskeletal System · Normal	281 Participants	283 Participants	282 Participants
Change in Physical Examination At week -2, Musculoskeletal System · Abnormal, NCS	6 Participants	5 Participants	6 Participants
Change in Physical Examination At week -2, Musculoskeletal System · Abnormal, CS	0 Participants	2 Participants	2 Participants
Change in Physical Examination At week 30, Musculoskeletal System · Normal	252 Participants	247 Participants	270 Participants
Change in Physical Examination At week 30, Musculoskeletal System · Abnormal, NCS	3 Participants	4 Participants	3 Participants
Change in Physical Examination At week 30, Musculoskeletal System · Abnormal, CS	1 Participants	2 Participants	3 Participants
Change in Physical Examination At week -2, Skin · Normal	253 Participants	252 Participants	254 Participants
Change in Physical Examination At week -2, Skin · Abnormal, NCS	28 Participants	37 Participants	29 Participants
Change in Physical Examination At week -2, Skin · Abnormal, CS	6 Participants	1 Participants	7 Participants
Change in Physical Examination At week 30, Skin · Normal	226 Participants	217 Participants	240 Participants
Change in Physical Examination At week 30, Skin · Abnormal, NCS	25 Participants	33 Participants	31 Participants
Change in Physical Examination At week 30, Skin · Abnormal, CS	5 Participants	3 Participants	5 Participants
Change in Physical Examination At week -2, Head,Ears,Eyes,Nose, Throat, Neck · Normal	273 Participants	281 Participants	277 Participants
Change in Physical Examination At week -2, Head,Ears,Eyes,Nose, Throat, Neck · Abnormal, NCS	12 Participants	7 Participants	7 Participants
Change in Physical Examination At week -2, Head,Ears,Eyes,Nose, Throat, Neck · Abnormal, CS	2 Participants	2 Participants	6 Participants
Change in Physical Examination At week 30, Head,Ears,Eyes,Nose, Throat, Neck · Normal	245 Participants	244 Participants	263 Participants
Change in Physical Examination At week 30, Head,Ears,Eyes,Nose, Throat, Neck · Abnormal, NCS	9 Participants	7 Participants	8 Participants
Change in Physical Examination At week 30, Head,Ears,Eyes,Nose, Throat, Neck · Abnormal, CS	2 Participants	2 Participants	5 Participants
Change in Physical Examination At week -2, Respiratory System · Normal	287 Participants	288 Participants	287 Participants
Change in Physical Examination At week -2, Respiratory System · Abnormal, NCS	0 Participants	1 Participants	2 Participants
Change in Physical Examination At week -2, Respiratory System · Abnormal, CS	0 Participants	1 Participants	1 Participants
Change in Physical Examination At week 30, Respiratory System · Normal	255 Participants	250 Participants	274 Participants
Change in Physical Examination At week 30, Respiratory System · Abnormal, NCS	1 Participants	2 Participants	2 Participants
Change in Physical Examination At week 30, Respiratory System · Abnormal, CS	0 Participants	1 Participants	0 Participants
Change in Physical Examination At week -2, Lymph Node Palpation · Normal	284 Participants	284 Participants	285 Participants
Change in Physical Examination At week -2, Lymph Node Palpation · Abnormal, NCS	2 Participants	5 Participants	4 Participants
Change in Physical Examination At week -2, Lymph Node Palpation · Abnormal, CS	1 Participants	1 Participants	1 Participants
Change in Physical Examination At week 30, Lymph Node Palpation · Normal	255 Participants	250 Participants	271 Participants
Change in Physical Examination At week 30, Lymph Node Palpation · Abnormal, NCS	1 Participants	3 Participants	5 Participants
Change in Physical Examination At week 30, Lymph Node Palpation · Abnormal, CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination At week -2, Thyroid Gland · Normal	280 Participants	285 Participants	281 Participants
Change in Physical Examination At week -2, Thyroid Gland · Abnormal, NCS	6 Participants	3 Participants	9 Participants
Change in Physical Examination At week -2, Thyroid Gland · Abnormal, CS	1 Participants	2 Participants	0 Participants
Change in Physical Examination At week 30, Thyroid Gland · Normal	253 Participants	249 Participants	270 Participants
Change in Physical Examination At week 30, Thyroid Gland · Abnormal, NCS	2 Participants	2 Participants	5 Participants
Change in Physical Examination At week 30, Thyroid Gland · Abnormal, CS	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: week 30, week 35

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed"=participants with available data.

This outcome measure is only applicable for the semaglutide arms. Anti-semaglutide antibody level at week 30 and week 35 are presented. Antibody levels were measured in percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T; B =Bound, T = Total). Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=3 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Anti-semaglutide Antibody Levels At week 30	—	2.8 %B/T Standard Deviation 0.2	—
Anti-semaglutide Antibody Levels At week 35	—	3.3 %B/T Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Week 0, week 16, week 30, week 35

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies were presented. Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=287 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 0 · Yes (positive for antibody)	0 Participants	1 Participants	—
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 0 · No (negative for antibody)	285 Participants	288 Participants	—
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 16 · Yes (positive for antibody)	1 Participants	0 Participants	—
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 16 · No (negative for antibody)	284 Participants	290 Participants	—
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 30 · Yes (positive for antibody)	0 Participants	2 Participants	—
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 30 · No (negative for antibody)	257 Participants	261 Participants	—
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 35 · Yes (positive for antibody)	0 Participants	3 Participants	—
Occurence of Anti-semaglutide Antibodies (Yes/no) At week 35 · No (negative for antibody)	262 Participants	261 Participants	—

SECONDARY outcome

Timeframe: Week 0, week 16, week 30, week 35

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies with in-vitro neutralising effect was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=287 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 0 · Yes (positive for antibody)	0 Participants	0 Participants	—
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 0 · No (negative for antibody)	285 Participants	289 Participants	—
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 16 · Yes (positive for antibody)	0 Participants	0 Participants	—
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 16 · No (negative for antibody)	285 Participants	290 Participants	—
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 30 · Yes (positive for antibody)	0 Participants	0 Participants	—
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 30 · No (negative for antibody)	257 Participants	263 Participants	—
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 35 · Yes (positive for antibody)	0 Participants	0 Participants	—
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) At week 35 · No (negative for antibody)	262 Participants	264 Participants	—

SECONDARY outcome

Timeframe: Week 35

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies cross reacting with endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies cross reacting with endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=262 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=264 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) Yes (positive for antibody)	0 Participants	1 Participants	—
Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) No (negative for antibody)	262 Participants	263 Participants	—

SECONDARY outcome

Timeframe: Week 35

Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data.

This outcome measure is only applicable for the semaglutide arms. Development of cross reacting antibodies with in-vitro neutralising effect to endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect to endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=262 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=264 Participants Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) Yes (positive for antibody)	0 Participants	0 Participants	—
Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) No (negative for antibody)	262 Participants	264 Participants	—

Adverse Events

Semaglutide 0.5 mg

Serious events: 18 serious events

Other events: 135 other events

Deaths: 1 deaths

Semaglutide 1.0 mg

Serious events: 19 serious events

Other events: 139 other events

Deaths: 1 deaths

Sitagliptin

Serious events: 12 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Semaglutide 0.5 mg n=287 participants at risk Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Semaglutide 1.0 mg n=290 participants at risk Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.	Sitagliptin n=290 participants at risk Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
Gastrointestinal disorders Abdominal discomfort	2.8% 8/287 • Number of events 9 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	5.2% 15/290 • Number of events 16 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	0.34% 1/290 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Metabolism and nutrition disorders Decreased appetite	7.3% 21/287 • Number of events 21 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	7.9% 23/290 • Number of events 23 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	1.4% 4/290 • Number of events 4 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Eye disorders Diabetic retinopathy	6.3% 18/287 • Number of events 18 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	4.8% 14/290 • Number of events 14 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	3.4% 10/290 • Number of events 10 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Diarrhoea	20.2% 58/287 • Number of events 94 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	16.9% 49/290 • Number of events 99 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	6.9% 20/290 • Number of events 24 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Investigations Lipase increased	7.7% 22/287 • Number of events 30 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	4.5% 13/290 • Number of events 15 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	7.6% 22/290 • Number of events 30 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Infections and infestations Nasopharyngitis	5.9% 17/287 • Number of events 21 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	3.1% 9/290 • Number of events 12 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	3.8% 11/290 • Number of events 15 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Nausea	7.7% 22/287 • Number of events 24 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	13.4% 39/290 • Number of events 54 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	1.7% 5/290 • Number of events 7 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Infections and infestations Upper respiratory tract infection	9.8% 28/287 • Number of events 37 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	13.1% 38/290 • Number of events 45 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	14.8% 43/290 • Number of events 64 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Vomiting	4.9% 14/287 • Number of events 16 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	6.6% 19/290 • Number of events 22 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.	1.0% 3/290 • Number of events 5 • From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 5 weeks. Evaluation of safety was based on safety analysis set (SAS) comprised of all randomised participants exposed to at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

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.
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Trial Outcomes & Findings for Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT) (NCT NCT03061214)

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