Study S001204

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00763815
Acronym: GETGOAL-P
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 484
Start: 2008-09
Primary completion: 2011-06
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DEVICE:Pen auto-injector; DRUG:Pioglitazone; DRUG:Metformin
Results posted: TRUE
Secondary identifiers: OTHER:EudraCT: 2007-005884-92

Registered primary outcomes

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

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
R0025751	Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Pinget M, Diabetes, obesity & metabolism	2013	Randomized trial	PMID 23627775 DOI	cites ClinicalTrials.gov:NCT00763815; registry reference RESULT:23627775