Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

• Status: Completed
• Trial end date: 2013-07-01

Summary

Primary Objective:

• To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after a standardized breakfast at the end of a 8-week treatment period in participants with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).

Secondary Objectives:

• To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after an 8-week treatment period in participants with T2DM not adequately controlled with insulin glargine (± metformin) on:

• Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast,

• Appetite perceptions after standardized dinner,

• Gastric emptying after a standardized labelled test meal,

• Fasting plasma glucose, 24-hour plasma glucose profile,

• Glycosylated hemoglobin (HbA1c),

• Insulin glargine dose,

• 7-point self monitored plasma glucose (SMPG),

• Body weight and waist circumference,

• 24-hour heart rate and blood pressure,

• To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin).

• Phase: Phase 2

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Liraglutide; Lixisenatide; Metformin