At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized Two-arm Parallel Group Study to Compare the Effects of 4-week QD Treatment With Lixisenatide or Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
In Brief
A Phase 2 clinical trial evaluating Lixisenatide (AVE0010), Pen auto-injector, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 148 participants across 7 sites.
Detailed Summary
The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4. The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY \[PYY3-36\] and oxyntomodulin); and to assess the clinical and laboratory safety profile.
Study Details
Timeline
Interventions
Self administered by subcutaneous injections once daily 30 minutes before breakfast.
Self administered by subcutaneous injections once daily 30 minutes before breakfast.
Metformin to be continued at stable dose (1.5 gram per day) up to Week 4.