Study S001498

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

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT02207374
Acronym: SUSTAIN™
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 601
Start: 2014-08-04
Primary completion: 2016-02-27
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:semaglutide; DRUG:DPP-4 inhibitor
Results posted: TRUE
Secondary identifiers: OTHER:U1111-1140-3081; REGISTRY:JapicCTI-142640

Registered primary outcomes

Number of Treatment Emergent Adverse Events (TEAEs) [Weeks 0-56]

Linked records (5)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0055572	Safety profile of semaglutide in people aged 55 years and over: pooled data from the PIONEER, SUSTAIN and STEP phase 3 clinical programmes Marwan Sabbagh, Alzheimer s & Dementia	2023	Other trial	DOI	cites ClinicalTrials.gov:NCT02207374
R0018529	Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Husain M, Cardiovascular diabetology	2020	Randomized trial	PMID 32998732 DOI	cites ClinicalTrials.gov:NCT02207374; registry reference DERIVED:32998732
R0013229	Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Carlsson Petri KC, Diabetes therapy : research, treatment and education of diabetes and related disorders	2018	Other trial	PMID 29907893 DOI	cites ClinicalTrials.gov:NCT02207374; registry reference RESULT:29907893
R0020727	Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Petri KCC, Diabetes, obesity & metabolism	2018	Randomized trial	PMID 29748996 DOI	registry reference RESULT:29748996
R0025024	Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Kaku K, Diabetes, obesity & metabolism	2018	Randomized trial	PMID 29322610 DOI	cites ClinicalTrials.gov:NCT02207374; registry reference RESULT:29322610