Study S000491

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

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00713830
Acronym: GETGOAL-S
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 859
Start: 2008-07
Primary completion: 2011-01
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DEVICE:Pen auto-injector; DRUG:Sulfonylurea; DRUG:Metformin
Results posted: TRUE
Secondary identifiers: OTHER:EudraCT 2007-005881-11

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
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:NCT00713830; 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:NCT00713830; registry reference DERIVED:27267268
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:NCT00713830; registry reference DERIVED:27252787
R0025645	Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S). Rosenstock J, Journal of diabetes and its complications	2014	Randomized trial	PMID 24650952 DOI	cites ClinicalTrials.gov:NCT00713830; registry reference RESULT:24650952