SUSTAIN™

CompletedPhase 3Results posted

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

308

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-9.5%

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 IDNCT02254291

Org study IDNN9535-4092

Secondary IDJapicCTI-142663JAPIC

Secondary IDU1111-1140-5334WHO

Timeline

Milestones

Study first posted2014-10-01estimated

Study start2014-10-02actual

Primary completion2015-11-11actual

Study completion2015-11-11actual

Last update posted2018-09-13actual

Results first posted2018-09-13actual

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 20 years or older at the time of signing informed consent

•Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening

•Japanese subjects diagnosed with type 2 diabetes who are:

a)on stable OAD monotherapy at a half-maximum dose or below according to the approved Japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be applied.). 'Stable' is defined as unchanged medication and unchanged dose, or

b)on stable diet and exercise therapy for at least 30 days prior to screening (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, diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period

•Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days prior to screening

•Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject treated with OAD monotherapy) in a period of 60 days prior to screening. An exception is short-term treatment (7 days or less 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 of 50 ng/L (pg/mL) or greater

•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) less than 60 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 (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 and week 30

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	-1.87	—
Semaglutide 1.0 mg	-2.18	—
Sitagliptin	-0.74	—

Secondary/protocol endpoint

Change in Glycosylated Haemoglobin A1c (HbA1c)

Time frame:Week 0 and week 30

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 0-30

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Number of events	95% CI
Semaglutide 0.5 mg	228	—
Semaglutide 1.0 mg	197	—
Sitagliptin	186	—

Primary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Weeks 0-30

Treatment-emergent AEs (any)

event count, event

Secondary/registry result

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

Time frame:Weeks 0-30

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
Semaglutide 0.5 mg	0	—
Semaglutide 1.0 mg	1	—
Sitagliptin	0	—

Secondary/protocol endpoint

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

Time frame:Weeks 0-30

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Publications (2)

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
Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes.
Diabetes, obesity & metabolism2018 Feb (month)PMID28786547doi:10.1111/dom.13082via 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.