Trial · NCT01930188

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

NCT01930188, Phase 3, Completed, Novo Nordisk A/S; results first posted 2019-01-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT01930188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01930188

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT01930188
Status: Completed
Phases: Phase 3
Enrollment: 1,231 participants, actual
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes, Diabetes Mellitus, Type 2
Interventions: semaglutide, sitagliptin, placebo, placebo
First posted: 2013-08-28
Last updated: 2019-06-13
Other registries' IDs: eudract:2012-004827-19
Results first posted: 2019-01-07
Limitations and caveats: None reported

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in HbA1c (Glycosylated Haemoglobin) From Baseline	Week 0, week 56	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.
Secondary	Change in Body Weight From Baseline	Week 0, week 56	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.
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline	Week 0, week 56	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.
Secondary	Change in Systolic and Diastolic Blood Pressure From Baseline	Week 0, week 56	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
Secondary	Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline	Week 0, week 56	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.
Secondary	Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)	After 56 weeks treatment	Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in HbA1c (Glycosylated Haemoglobin) From Baseline	Week 0, week 56	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.	percentage of glycosylated haemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Change in Body Weight From Baseline	Week 0, week 56	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.	kilograms	LEAST_SQUARES_MEAN
SECONDARY	Change in Fasting Plasma Glucose (FPG) From Baseline	Week 0, week 56	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	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in Systolic and Diastolic Blood Pressure From Baseline	Week 0, week 56	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	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline	Week 0, week 56	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.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)	After 56 weeks treatment	Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin	Subjects	NUMBER

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in HbA1c (Glycosylated Haemoglobin) From Baseline	Semaglutide 0.5 mg + Sitagliptin Placebo		-1.32	Standard Error 0.05	percentage of glycosylated haemoglobin
Change in HbA1c (Glycosylated Haemoglobin) From Baseline	Semaglutide 1.0 mg + Sitagliptin Placebo		-1.61	Standard Error 0.05	percentage of glycosylated haemoglobin
Change in HbA1c (Glycosylated Haemoglobin) From Baseline	Sitagliptin + Semaglutide Placebo		-0.55	Standard Error 0.05	percentage of glycosylated haemoglobin
Change in Body Weight From Baseline	Semaglutide 0.5 mg + Sitagliptin Placebo		-4.28	Standard Error 0.25	kilograms
Change in Body Weight From Baseline	Semaglutide 1.0 mg + Sitagliptin Placebo		-6.13	Standard Error 0.25	kilograms
Change in Body Weight From Baseline	Sitagliptin + Semaglutide Placebo		-1.93	Standard Error 0.26	kilograms
Change in Fasting Plasma Glucose (FPG) From Baseline	Semaglutide 0.5 mg + Sitagliptin Placebo		-37.38	Standard Error 1.79	mg/dL
Change in Fasting Plasma Glucose (FPG) From Baseline	Semaglutide 1.0 mg + Sitagliptin Placebo		-46.72	Standard Error 1.78	mg/dL
Change in Fasting Plasma Glucose (FPG) From Baseline	Sitagliptin + Semaglutide Placebo		-19.85	Standard Error 1.88	mg/dL
Change in Systolic and Diastolic Blood Pressure From Baseline	Semaglutide 0.5 mg + Sitagliptin Placebo	Systolic blood pressure	-5.07	Standard Error 0.64	mmHg

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Semaglutide 0.5 mg + Sitagliptin Placebo	409
Overall Study	STARTED	Semaglutide 1.0 mg + Sitagliptin Placebo	409
Overall Study	STARTED	Sitagliptin + Semaglutide Placebo	407
Overall Study	Premature Discontinuation of Treatment	Semaglutide 0.5 mg + Sitagliptin Placebo	53
Overall Study	Premature Discontinuation of Treatment	Semaglutide 1.0 mg + Sitagliptin Placebo	61
Overall Study	Premature Discontinuation of Treatment	Sitagliptin + Semaglutide Placebo	32
Overall Study	COMPLETED	Semaglutide 0.5 mg + Sitagliptin Placebo	387
Overall Study	COMPLETED	Semaglutide 1.0 mg + Sitagliptin Placebo	388
Overall Study	COMPLETED	Sitagliptin + Semaglutide Placebo	388
Overall Study	NOT COMPLETED	Semaglutide 0.5 mg + Sitagliptin Placebo	22

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events476

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Semaglutide 1.0 mg + Sitagliptin Placebo	23	409	29
other	Constipation	Gastrointestinal disorders	Semaglutide 0.5 mg + Sitagliptin Placebo	18	409	20
other	Constipation	Gastrointestinal disorders	Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg	5	204	5
other	Constipation	Gastrointestinal disorders	Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg	3	203	4
other	Decreased appetite	Metabolism and nutrition disorders	Semaglutide 1.0 mg + Sitagliptin Placebo	27	409	29
other	Decreased appetite	Metabolism and nutrition disorders	Semaglutide 0.5 mg + Sitagliptin Placebo	26	409	28
other	Decreased appetite	Metabolism and nutrition disorders	Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg	6	204	6
other	Decreased appetite	Metabolism and nutrition disorders	Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg	5	203	5
other	Diarrhoea	Gastrointestinal disorders	Semaglutide 1.0 mg + Sitagliptin Placebo	53	409	85
other	Diarrhoea	Gastrointestinal disorders	Semaglutide 0.5 mg + Sitagliptin Placebo	53	409	91

1 to 10 of 476Source ClinicalTrials.gov

See all 476 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Semaglutide 1.0 mg + Sitagliptin Placebo
Total, all-cause mortality	Semaglutide 0.5 mg + Sitagliptin Placebo
Total, all-cause mortality	Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg
Total, all-cause mortality	Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg
Total, other adverse events	Semaglutide 1.0 mg + Sitagliptin Placebo	197	409
Total, other adverse events	Semaglutide 0.5 mg + Sitagliptin Placebo	208	409
Total, other adverse events	Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg	75	204
Total, other adverse events	Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg	85	203
Total, serious adverse events	Semaglutide 1.0 mg + Sitagliptin Placebo	30	409
Total, serious adverse events	Semaglutide 0.5 mg + Sitagliptin Placebo	30	409

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers16

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28385659	RESULT	PubMed
29748996	RESULT	PubMed
29764222	RESULT	PubMed
29766634	RESULT	PubMed
29862621	RESULT	PubMed
29907893	RESULT	PubMed
30615985	RESULT	PubMed
30865526	BACKGROUND	PubMed
30938762	BACKGROUND	PubMed
31215727	DERIVED	PubMed

1 to 10 of 16

See all 16 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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