Study S001311

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes. A 30-week Randomised, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-centre and Multi-national Trial

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03061214
Acronym: SUSTAIN
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 868
Start: 2017-08-28
Primary completion: 2019-03-14
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide 0.5 mg; DRUG:Semaglutide 1.0 mg; DRUG:Sitagliptin placebo; DRUG:Sitagliptin; DRUG:Semaglutide placebo 0.5 mg; DRUG:Semaglutide placebo 1.0 mg
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1149-0432; REGISTRY:CTR20161003

Registered primary outcomes

Change in HbA1c [Week 0, week 30]

Linked records (2)

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
R0007730	Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Sitagliptin as Metformin Add-on in a Korean Population with Type 2 Diabetes. Lee BW, Diabetes therapy : research, treatment and education of diabetes and related disorders	2024	Other trial	PMID 38236431 DOI	cites ClinicalTrials.gov:NCT03061214; registry reference DERIVED:38236431
R0014802	Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes in SUSTAIN China: A 30-week, double-blind, phase 3a, randomized trial. Ji L, Diabetes, obesity & metabolism	2021	Randomized trial	PMID 33074557 DOI	registry reference RESULT:33074557