Study S000415

A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00976937
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 319
Start: 2009-08
Primary completion: 2011-03
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Lixisenatide Placebo; DEVICE:Pen auto-injector; DRUG:Sitagliptin; DRUG:Sitagliptin Placebo; DRUG:Metformin
Results posted: TRUE
Secondary identifiers: OTHER:EudraCT:2008-007 334-22

Registered primary outcomes

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24 [Week 24]

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