Trial Outcomes & Findings for Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (NCT NCT01930188)

NCT ID: NCT01930188

Last Updated: 2019-06-13

Results Overview

Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1231 participants

Primary outcome timeframe

Week 0, week 56

Results posted on

2019-06-13

Participant Flow

The trial was conducted at 124 sites in 18 countries: Argentina: 4; Bulgaria: 10; Czech Republic: 5; Hong Kong: 1; Hungary: 4; India: 11; Japan: 14; Mexico: 5 Norway: 5; Portugal: 6; Romania: 5; Russian Federation: 17; South Africa: 7; Spain: 7: Sweden: 4; Thailand: 4; Turkey: 9; and Ukraine: 6 sites.

Participant milestones

Participant milestones
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Study STARTED	409	409	407
Overall Study Premature Discontinuation of Treatment	53	61	32
Overall Study COMPLETED	387	388	388
Overall Study NOT COMPLETED	22	21	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Study unclassified	4	5	3
Overall Study Missing follow-up information	2	2	3
Overall Study Lost to Follow-up	5	2	2
Overall Study Death	2	1	3
Overall Study Withdrawal by Subject	9	11	8

Baseline Characteristics

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo n=409 Participants Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo n=409 Participants Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo n=407 Participants Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.	Total n=1225 Participants Total of all reporting groups
Age, Continuous	54.8 years STANDARD_DEVIATION 10.2 • n=5 Participants	56.0 years STANDARD_DEVIATION 9.4 • n=7 Participants	54.6 years STANDARD_DEVIATION 10.4 • n=5 Participants	55.1 years STANDARD_DEVIATION 10.0 • n=4 Participants
Sex: Female, Male Female	202 Participants n=5 Participants	204 Participants n=7 Participants	199 Participants n=5 Participants	605 Participants n=4 Participants
Sex: Female, Male Male	207 Participants n=5 Participants	205 Participants n=7 Participants	208 Participants n=5 Participants	620 Participants n=4 Participants
HbA1c	8.01 percentage STANDARD_DEVIATION 0.92 • n=5 Participants	8.04 percentage STANDARD_DEVIATION 0.93 • n=7 Participants	8.17 percentage STANDARD_DEVIATION 0.92 • n=5 Participants	8.07 percentage STANDARD_DEVIATION 0.93 • n=4 Participants
Body Weight	89.93 kilograms STANDARD_DEVIATION 20.39 • n=5 Participants	89.21 kilograms STANDARD_DEVIATION 20.74 • n=7 Participants	89.29 kilograms STANDARD_DEVIATION 19.67 • n=5 Participants	89.48 kilograms STANDARD_DEVIATION 20.26 • n=4 Participants
Fasting Plasma Glucose	9.33 mmol/L STANDARD_DEVIATION 2.38 • n=5 Participants	9.29 mmol/L STANDARD_DEVIATION 2.22 • n=7 Participants	9.60 mmol/L STANDARD_DEVIATION 2.16 • n=5 Participants	9.40 mmol/L STANDARD_DEVIATION 2.26 • n=4 Participants
Diastolic and Systolic Blood Pressure Diastolic Blood pressure	80.63 mmHg STANDARD_DEVIATION 9.76 • n=5 Participants	80.87 mmHg STANDARD_DEVIATION 9.08 • n=7 Participants	80.48 mmHg STANDARD_DEVIATION 8.70 • n=5 Participants	80.66 mmHg STANDARD_DEVIATION 9.19 • n=4 Participants
Diastolic and Systolic Blood Pressure Systolic Blood pressure	132.73 mmHg STANDARD_DEVIATION 16.09 • n=5 Participants	132.56 mmHg STANDARD_DEVIATION 13.93 • n=7 Participants	132.66 mmHg STANDARD_DEVIATION 14.58 • n=5 Participants	132.65 mmHg STANDARD_DEVIATION 14.88 • n=4 Participants

PRIMARY outcome

Timeframe: Week 0, week 56

Population: Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo n=409 Participants Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo n=409 Participants Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo n=407 Participants Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Change in HbA1c (Glycosylated Haemoglobin) From Baseline	-1.32 percentage of glycosylated haemoglobin Standard Error 0.05	-1.61 percentage of glycosylated haemoglobin Standard Error 0.05	-0.55 percentage of glycosylated haemoglobin Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo n=409 Participants Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo n=409 Participants Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo n=407 Participants Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Change in Body Weight From Baseline	-4.28 kilograms Standard Error 0.25	-6.13 kilograms Standard Error 0.25	-1.93 kilograms Standard Error 0.26

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit

Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo n=409 Participants Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo n=409 Participants Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo n=407 Participants Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Change in Fasting Plasma Glucose (FPG) From Baseline	-37.38 mg/dL Standard Error 1.79	-46.72 mg/dL Standard Error 1.78	-19.85 mg/dL Standard Error 1.88

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit

Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo n=409 Participants Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo n=409 Participants Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo n=407 Participants Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Change in Systolic and Diastolic Blood Pressure From Baseline Systolic blood pressure	-5.07 mmHg Standard Error 0.64	-5.61 mmHg Standard Error 0.63	-2.29 mmHg Standard Error 0.67
Change in Systolic and Diastolic Blood Pressure From Baseline Diastolic blood pressure	-2.01 mmHg Standard Error 0.42	-1.91 mmHg Standard Error 0.42	-1.11 mmHg Standard Error 0.44

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Out of the 1225 subjects in FAS, 76 in semaglutide 0.5 mg arm, 76 in semaglutide 1.0 mg arm, and 113 in placebo arm had missing data for the endpoint. Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo n=333 Participants Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo n=333 Participants Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo n=294 Participants Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline	5.28 Units on a scale Standard Error 0.23	5.91 Units on a scale Standard Error 0.23	4.45 Units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: After 56 weeks treatment

Population: Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin

Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg + Sitagliptin Placebo n=409 Participants Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Semaglutide 1.0 mg + Sitagliptin Placebo n=409 Participants Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.	Sitagliptin + Semaglutide Placebo n=407 Participants Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no) Yes	215 Subjects	270 Subjects	83 Subjects
Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no) No	194 Subjects	139 Subjects	324 Subjects

Adverse Events

Semaglutide 1.0 mg + Sitagliptin Placebo

Serious events: 30 serious events

Other events: 197 other events

Deaths: 0 deaths

Semaglutide 0.5 mg + Sitagliptin Placebo

Serious events: 30 serious events

Other events: 208 other events

Deaths: 0 deaths

Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg

Serious events: 13 serious events

Other events: 75 other events

Deaths: 0 deaths

Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg

Serious events: 16 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Semaglutide 1.0 mg + Sitagliptin Placebo n=409 participants at risk Semaglutide 1.0 mg once-weekly + Sitagliptin placebo once-daily	Semaglutide 0.5 mg + Sitagliptin Placebo n=409 participants at risk Semaglutide 0.5 mg once-weekly + Sitagliptin placebo once-daily	Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg n=204 participants at risk Sitagliptin 100 mg once-daily + Semaglutide placebo 1.0 mg once-weekly	Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg n=203 participants at risk Sitagliptin 100 mg once-daily + Semaglutide placebo 0.5 mg once-weekly
Gastrointestinal disorders Constipation	5.6% 23/409 • Number of events 29 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	4.4% 18/409 • Number of events 20 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.5% 5/204 • Number of events 5 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	1.5% 3/203 • Number of events 4 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Metabolism and nutrition disorders Decreased appetite	6.6% 27/409 • Number of events 29 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 26/409 • Number of events 28 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.9% 6/204 • Number of events 6 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.5% 5/203 • Number of events 5 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Gastrointestinal disorders Diarrhoea	13.0% 53/409 • Number of events 85 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	13.0% 53/409 • Number of events 91 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 13/204 • Number of events 17 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	7.9% 16/203 • Number of events 18 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Gastrointestinal disorders Dyspepsia	4.9% 20/409 • Number of events 27 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 26/409 • Number of events 28 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.0% 4/204 • Number of events 4 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.5% 5/203 • Number of events 7 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Nervous system disorders Headache	7.1% 29/409 • Number of events 42 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 26/409 • Number of events 81 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	4.4% 9/204 • Number of events 19 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	3.9% 8/203 • Number of events 10 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Infections and infestations Influenza	5.4% 22/409 • Number of events 25 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	4.4% 18/409 • Number of events 23 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 13/204 • Number of events 14 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.9% 14/203 • Number of events 16 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Investigations Lipase increased	7.8% 32/409 • Number of events 38 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	8.1% 33/409 • Number of events 41 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 13/204 • Number of events 16 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	7.9% 16/203 • Number of events 17 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Infections and infestations Nasopharyngitis	7.1% 29/409 • Number of events 33 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	12.2% 50/409 • Number of events 63 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	9.3% 19/204 • Number of events 20 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	11.3% 23/203 • Number of events 31 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Gastrointestinal disorders Nausea	17.6% 72/409 • Number of events 140 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	17.8% 73/409 • Number of events 110 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 13/204 • Number of events 15 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	8.4% 17/203 • Number of events 23 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Infections and infestations Pharyngitis	2.4% 10/409 • Number of events 12 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	1.7% 7/409 • Number of events 7 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.5% 5/204 • Number of events 5 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	6.4% 13/203 • Number of events 16 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.
Gastrointestinal disorders Vomiting	10.0% 41/409 • Number of events 119 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	8.1% 33/409 • Number of events 49 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.9% 6/204 • Number of events 7 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.	2.5% 5/203 • Number of events 9 • Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks). Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under 'total number of deaths resulting from adverse events'.

Additional Information

Global Clinical Registry (GCR, 1452)

Novo Nordisk A/S

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 investigators(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER