Study S000763

A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

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

Registration

Registration: NCT02973321
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 296
Start: 2016-12-02
Primary completion: 2017-12-27
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:SAR425899; DRUG:Placebo; DRUG:Liraglutide; DRUG:Metformin
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2016-001328-77; OTHER:U1111-1179-4786; NIH:2016

Registered primary outcomes

Change From Baseline in HbA1c to Week 26 [Baseline, Week 26]

Linked records (1)

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
R0010966	Improved postprandial glucose metabolism in type 2 diabetes by the dual glucagon-like peptide-1/glucagon receptor agonist SAR425899 in comparison with liraglutide. Schiavon M, Diabetes, obesity & metabolism	2021	Randomized trial	PMID 33822469 DOI	cites ClinicalTrials.gov:NCT02973321; registry reference DERIVED:33822469