LivingGLP1
Study S000488

A Randomized, Double-Blind, Placebo-Controlled, 2-arm Parallel-group, Multicenter Study With a 24-Week Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Sulfonylurea

Registration

Registration
NCT00866658
Acronym
GETGOAL-L-ASIA
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
311
Start
2009-03
Primary completion
2010-06
Lead sponsor
Sanofi
Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DEVICE:Pen auto-injector; DRUG:Sulfonylurea; DRUG:Basal Insulin
Results posted
TRUE

Registered primary outcomes

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

Linked records (3)

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.
RecordTitleYearDesignIdentifiersLink basis
R0012333Achieving 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
2020Randomized trialPMID 31956422DOIcites ClinicalTrials.gov:NCT00866658; registry reference DERIVED:31956422
R0025138Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin±Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study.
Seino Y, Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme
2015OtherPMID 26039935DOIcites ClinicalTrials.gov:NCT00866658; registry reference DERIVED:26039935
R0022626Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia).
Seino Y, Diabetes, obesity & metabolism
2012Randomized trialPMID 22564709DOIregistry reference RESULT:22564709