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SUSTAIN™ 2

CompletedPhase 3Results posted

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

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 (SUSTAIN™ 2 - vs. DPP-4 Inhibitor)

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

141

Recruiting sites

—

Enrollment

1,231

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01930188

Org study IDNN9535-3626

Secondary ID132366JapicCTI

Secondary ID2012-004827-19

Secondary IDCTRI/2014/05/004626Clinical Trial Registry India (CTRI)

Secondary IDU1111-1135-8730WHO

Timeline

Milestones

Study first posted2013-08-28estimated

Study start2013-12-02actual

Primary completion2015-10-12actual

Study completion2015-10-12actual

Results first posted2019-01-07actual

Last update posted2019-06-13actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight From Baseline

Time frame:Week 0, week 56

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms	95% CI
Semaglutide 0.5 mg + Sitagliptin Placebo	-4.28	—
Semaglutide 1.0 mg + Sitagliptin Placebo	-6.13	—
Sitagliptin + Semaglutide Placebo	-1.93	—

Secondary/protocol endpoint

Change in Body Weight From Baseline

Time frame:Week 0, week 56

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Change in HbA1c (Glycosylated Haemoglobin) From Baseline

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated haemoglobin	95% CI
Semaglutide 0.5 mg + Sitagliptin Placebo	-1.32	—
Semaglutide 1.0 mg + Sitagliptin Placebo	-1.61	—
Sitagliptin + Semaglutide Placebo	-0.55	—

treatment difference-1.0695% CI-1.21 – -0.91p<0.0001Mixed Models Analysis

treatment difference-0.9295% CI-1.21 – -0.62p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c (Glycosylated Haemoglobin) From Baseline

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG) From Baseline

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Semaglutide 0.5 mg + Sitagliptin Placebo	-37.38	—
Semaglutide 1.0 mg + Sitagliptin Placebo	-46.72	—
Sitagliptin + Semaglutide Placebo	-19.85	—

Secondary/registry result

Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

Time frame:After 56 weeks treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Subjects	95% CI
Semaglutide 0.5 mg + Sitagliptin PlaceboYes	215	—
No	194	—
Semaglutide 1.0 mg + Sitagliptin PlaceboYes	270	—
No	139	—
Sitagliptin + Semaglutide PlaceboYes	83	—
No	324	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) From Baseline

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

Time frame:After 56 weeks treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Change in Systolic and Diastolic Blood Pressure From Baseline

Time frame:Week 0, week 56

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Semaglutide 0.5 mg + Sitagliptin PlaceboSystolic blood pressure	-5.07	—
Diastolic blood pressure	-2.01	—
Semaglutide 1.0 mg + Sitagliptin PlaceboSystolic blood pressure	-5.61	—
Diastolic blood pressure	-1.91	—
Sitagliptin + Semaglutide PlaceboSystolic blood pressure	-2.29	—
Diastolic blood pressure	-1.11	—

Secondary/protocol endpoint

Change in Systolic and Diastolic Blood Pressure From Baseline

Time frame:Week 0, week 56

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/registry result

Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	95% CI
Semaglutide 0.5 mg + Sitagliptin Placebo	5.28	—
Semaglutide 1.0 mg + Sitagliptin Placebo	5.91	—
Sitagliptin + Semaglutide Placebo	4.45	—

Secondary/protocol endpoint

Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline

Time frame:Week 0, week 56

change from baseline, improvement

Publications (16)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study.
PharmacoEconomics - open2023 Jul (month)PMID37178435doi:10.1007/s41669-023-00416-zvia clinicaltrials gov reference derived + pubmed nct search
Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis.
The Journal of clinical endocrinology and metabolism2020 Dec 1PMID32827435doi:10.1210/clinem/dgaa577via clinicaltrials gov reference derived + pubmed nct search
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Cardiovascular diabetology2020 Sep 30PMID32998732doi:10.1186/s12933-020-01106-4via clinicaltrials gov reference derived + pubmed nct search
Once-Weekly Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 May (month)PMID32193837doi:10.1007/s13300-020-00796-zvia clinicaltrials gov reference derived + pubmed nct search
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Diabetes, obesity & metabolism2020 Mar (month)PMID31903692doi:10.1111/dom.13955via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.
The Journal of clinical endocrinology and metabolism2020 Feb 1PMID31769496doi:10.1210/clinem/dgz072via clinicaltrials gov reference derived + pubmed nct search
Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials.
Diabetes, obesity & metabolism2019 Oct (month)PMID31215727doi:10.1111/dom.13816via clinicaltrials gov reference derived + pubmed nct search
Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials.
Diabetes & metabolism2019 Oct (month)PMID30615985doi:10.1016/j.diabet.2018.12.001via CT.gov reference
Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide.
The Journal of clinical endocrinology and metabolism2019 Sep 1PMID30938762doi:10.1210/jc.2018-02685via CT.gov background
GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2019 Jun (month)PMID30865526doi:10.4158/EP-2018-0444via CT.gov background
Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme.
Diabetes, obesity & metabolism2018 Oct (month)PMID29862621doi:10.1111/dom.13396via CT.gov reference
Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes.
Diabetes, obesity & metabolism2018 Sep (month)PMID29748996doi:10.1111/dom.13358via CT.gov reference
Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials.
Diabetes, obesity & metabolism2018 Sep (month)PMID29766634doi:10.1111/dom.13353via CT.gov reference
Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis.
Current medical research and opinion2018 Sep (month)PMID29764222doi:10.1080/03007995.2018.1476332via CT.gov reference
Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2018 Aug (month)PMID29907893doi:10.1007/s13300-018-0458-5via CT.gov reference + pubmed nct search
Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial.
The lancet. Diabetes & endocrinology2017 May (month)PMID28385659doi:10.1016/S2213-8587(17)30092-Xvia CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.