Study S002188

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00712673
Acronym: GETGOAL-M
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 680
Start: 2008-06
Primary completion: 2011-03
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DEVICE:Pen auto-injector; DRUG:Metformin
Results posted: TRUE
Secondary identifiers: OTHER:EudraCT 2007-005880-80

Registered primary outcomes

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

Linked records (4)

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:NCT00712673; registry reference DERIVED:39963952
R0014176	Postprandial Glucagon Reductions Correlate to Reductions in Postprandial Glucose and Glycated Hemoglobin with Lixisenatide Treatment in Type 2 Diabetes Mellitus: A Post Hoc Analysis. Ahrén B, Diabetes therapy : research, treatment and education of diabetes and related disorders	2016	Other trial	PMID 27319011 DOI	cites ClinicalTrials.gov:NCT00712673; registry reference DERIVED:27319011
R0014435	Efficacy of lixisenatide in patients with type 2 diabetes: A post hoc analysis of patients with diverse β-cell function in the GetGoal-M and GetGoal-S trials. Yabe D, Journal of diabetes and its complications	2016	Randomized trial	PMID 27267268 DOI	cites ClinicalTrials.gov:NCT00712673; registry reference DERIVED:27267268
R0025872	Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M). Ahrén B, Diabetes care	2013	Randomized trial	PMID 23536584 DOI	cites ClinicalTrials.gov:NCT00712673; registry reference RESULT:23536584