SUSTAIN™ 5

CompletedPhase 3Results posted

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

397

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 IDNCT02305381

Org study IDNN9535-3627

Secondary ID2013-004502-26

Secondary IDJapicCTI-142729JAPIC

Secondary IDU1111-1149-3738WHO

Timeline

Milestones

Study start2014-12-01actual

Study first posted2014-12-02estimated

Primary completion2015-11-21actual

Study completion2015-11-21actual

Results first posted2018-02-19actual

Last update posted2019-06-11actual

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

•Male or female, age at least 18 years at the time of signing inform consent. For Japan: Male or female, age at least 20 years at the time of signing informed consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin) 7.0 - 10.0 percent (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 an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with bolus insulin in connection with intercurrent illness - Experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness - History of pancreatitis (acute or chronic) - 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 2 (MEN 2) - Severe renal impairment 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 (NYHA) Class IV

Endpoints (16)

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

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Semaglutide 0.5 mg	-3.67	—
Semaglutide 1.0 mg	-6.42	—
Placebo	-1.36	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 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 (least_squares_mean), percentage of glycosylated hemoglobin	95% CI
Semaglutide 0.5 mg	-1.45	—
Semaglutide 1.0 mg	-1.85	—
Placebo	-0.09	—

Treatment difference-1.7595% CI-2.01 – -1.50p< 0.0001Mixed Models Analysis

Treatment difference-1.3595% CI-1.61 – -1.10p< 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 (least_squares_mean), mg/dL	95% CI
Semaglutide 0.5 mg	-29.14	—
Semaglutide 1.0 mg	-42.38	—
Placebo	-8.51	—

Secondary/registry result/low confidence

Change in Insulin Dose

Time frame:week 0, week 30

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Semaglutide 0.5 mg	0.90	—
Semaglutide 1.0 mg	0.85	—
Placebo	0.96	—

Secondary/registry result

HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target

Time frame:After 30 weeks treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mg	60.6	—
Semaglutide 1.0 mg	78.6	—
Placebo	10.5	—

Secondary/registry result

HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target

Time frame:After 30 weeks treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mg	40.9	—
Semaglutide 1.0 mg	61.1	—
Placebo	4.5	—

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

Change in Insulin Dose

Time frame:week 0, week 30

ratio, improvement

Secondary/protocol endpoint

HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target

Time frame:After 30 weeks treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target

Time frame:After 30 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

Time frame:week 0, week 30

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (least_squares_mean), mm Hg	95% CI
Semaglutide 0.5 mgDiastolic blood pressure	-1.84	—
Systolic blood pressure	-4.29	—
Semaglutide 1.0 mgDiastolic blood pressure	-1.50	—
Systolic blood pressure	-7.27	—
PlaceboDiastolic blood pressure	-2.17	—
Systolic blood pressure	-0.99	—

Secondary/protocol endpoint

Change in Systolic and Diastolic Blood Pressure

Time frame:week 0, week 30

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

2 endpoints

Secondary/registry result

Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Time frame:week 0, week 30

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), scores on a scale	95% CI
Semaglutide 0.5 mg	2.73	—
Semaglutide 1.0 mg	3.47	—
Placebo	1.25	—

Secondary/protocol endpoint

Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Time frame:week 0, week 30

change from baseline, improvement

Publications (10)

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
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
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
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 Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial.
The Journal of clinical endocrinology and metabolism2018 Jun 1PMID29688502doi:10.1210/jc.2018-00070via 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.