Study S001439

A Randomized, Open-label, Active-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00707031
Acronym: GETGOAL-X
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 639
Start: 2008-06
Primary completion: 2010-11
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Lixisenatide (AVE0010); DEVICE:Pen auto-injector; DRUG:Exenatide; DEVICE:Prefilled pen injector; DRUG:Metformin
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2007-005883-28

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
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT00707031; registry reference DERIVED:39963952
R0022279	Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Rosenstock J, Diabetes care	2013	Randomized trial	PMID 23698396 DOI	cites ClinicalTrials.gov:NCT00707031; registry reference RESULT:23698396