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SUSTAIN™

CompletedPhase 3Results posted

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

601

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT02207374

Org study IDNN9535-4091

Secondary IDJapicCTI-142640JAPIC

Secondary IDU1111-1140-3081WHO

Timeline

Milestones

Study first posted2014-08-04estimated

Study start2014-08-04actual

Primary completion2016-02-27actual

Study completion2016-02-27actual

Last update posted2019-01-07actual

Results first posted2019-01-07actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age at least 20 years at the time of signing informed consent

•HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)

•Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are:

a)on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or

b)on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (week -2)

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 (e.g., abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period

•Treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness

•Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

•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 (MEN2)

•Impaired renal function defined as estimated glomerular filtration rate (eGFR) 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 (Visit 2 [week 0])

•Heart failure, New York Heart Association (NYHA) class IV

Endpoints (6)

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

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Secondary/registry result

Change in Glycosylated Haemoglobin A1c (HbA1c)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage (%) of HbA1c	95% CI
Semaglutide 0.5 mg	-1.74	—
Semaglutide 1.0 mg	-2.03	—
Additional OAD	-0.67	—

Secondary/protocol endpoint

Change in Glycosylated Haemoglobin A1c (HbA1c)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

4 endpoints

Primary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Weeks 0-56

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Number of events	95% CI
Semaglutide 0.5 mg	909	—
Semaglutide 1.0 mg	954	—
Additional OAD	269	—

Primary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Weeks 0-56

Treatment-emergent AEs (any)

event count, event

Secondary/registry result

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-56

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
Semaglutide 0.5 mg	4	—
Semaglutide 1.0 mg	8	—
Additional OAD	2	—

Secondary/protocol endpoint

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-56

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Publications (4)

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
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 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
Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial.
Diabetes, obesity & metabolism2018 May (month)PMID29322610doi:10.1111/dom.13218via 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.