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SUSTAIN™1

CompletedPhase 3Results posted

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

388

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT02054897

Org study IDNN9535-3623

Secondary ID2013-000632-94

Secondary IDJapicCTI-142442JAPIC

Secondary IDU1111-1139-3090WHO

Timeline

Milestones

Study start2014-02-03actual

Study first posted2014-02-04estimated

Primary completion2015-05-08actual

Study completion2015-05-08actual

Results first posted2018-01-23actual

Last update posted2019-06-12actual

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

•For Japan only: Male or female, age above or equal to 20 years at the time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening - HbA1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - 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 any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 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 or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as eGFR (estimated glomerular filtration rate ) below 30 mL/min/1.73 m^2 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 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

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilogram(s)	95% CI
Semaglutide 0.5 mg	-3.68	—
Semaglutide 1.0 mg	-4.67	—
Placebo	-0.89	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

8 endpoints

Primary/registry result

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Semaglutide 0.5 mg	-1.47	—
Semaglutide 1.0 mg	-1.56	—
Placebo	-0.00	—

Treatment difference-1.5395% CI-1.81 – -1.25p< 0.0001Mixed Models Analysis

Treatment difference-1.4395% CI-1.71 – -1.15p< 0.0001Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide 0.5 mg	-2.41	—
Semaglutide 1.0 mg	-2.39	—
Placebo	-0.55	—

Secondary/registry result

Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target

Time frame:At 30 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of subjects	95% CI
Semaglutide 0.5 mgYes	74.2	—
No	25.8	—
Semaglutide 1.0 mgYes	72.3	—
No	27.7	—
PlaceboYes	24.8	—
No	75.2	—

Secondary/registry result

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

Time frame:At 30 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of subjects	95% CI
Semaglutide 0.5 mgYes	59.4	—
No	40.6	—
Semaglutide 1.0 mgYes	60.0	—
No	40.0	—
PlaceboYes	13.2	—
No	86.8	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target

Time frame:At 30 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:At 30 weeks of 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

Time frame:Week 0, week 30

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Semaglutide 0.5 mgSystolic blood pressure	-2.29	—
Diastolic blood pressure	-0.73	—
Semaglutide 1.0 mgSystolic blood pressure	-2.74	—
Diastolic blood pressure	0.22	—
PlaceboSystolic blood pressure	-2.01	—
Diastolic blood pressure	0.60	—

Secondary/protocol endpoint

Change in Systolic and Diastolic Blood Pressure

Time frame:Week 0, week 30

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Publications (13)

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

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
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
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
Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach.
Diabetes, obesity & metabolism2019 Jan (month)PMID30047216doi:10.1111/dom.13479via 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 as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials.
Diabetes, obesity & metabolism2018 Sep (month)PMID29687620doi:10.1111/dom.13331via 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
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 monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.
The lancet. Diabetes & endocrinology2017 Apr (month)PMID28110911doi:10.1016/S2213-8587(17)30013-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.