Study S001185

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01169779
Acronym: GetGoal-M-Asia
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 391
Start: 2010-07
Primary completion: 2011-12
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DEVICE:Pen auto-injector; DRUG:Metformin; DRUG:Sulfonylurea
Results posted: TRUE
Secondary identifiers: OTHER:U1111-1116-8938

Registered primary outcomes

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [Baseline, Week 24]

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
R0025171	Lixisenatide improves glycemic outcomes of Japanese patients with type 2 diabetes: a meta-analysis. Seino H, Diabetology & metabolic syndrome	2016	Systematic review	PMID 27252787 DOI	cites ClinicalTrials.gov:NCT01169779; registry reference DERIVED:27252787
R0015972	Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). Yu Pan C, Diabetes/metabolism research and reviews	2014	Randomized trial	PMID 24639432 DOI	cites ClinicalTrials.gov:NCT01169779; registry reference RESULT:24639432