Study S002023

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 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00715624
Acronym: GETGOAL-L
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 496
Start: 2008-07
Primary completion: 2011-02
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DRUG:Basal Insulin; DRUG:Metformin; DEVICE:Pen auto-injector
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2007-005886-36

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
R0020702	Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Yao J, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 36809495 DOI	cites ClinicalTrials.gov:NCT00715624; registry reference DERIVED:36809495
R0012333	Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Davidson JA, Clinical diabetes and endocrinology	2020	Randomized trial	PMID 31956422 DOI	cites ClinicalTrials.gov:NCT00715624; registry reference DERIVED:31956422
R0022245	Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. Charbonnel B, Journal of diabetes and its complications	2014	Systematic review	PMID 25130920 DOI	cites ClinicalTrials.gov:NCT00715624; registry reference DERIVED:25130920
R0016145	Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Riddle MC, Diabetes care	2013	Randomized trial	PMID 23628617 DOI	registry reference RESULT:23628617