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

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).

Timeline

Start

2012-05

Primary completion

2013-07

Completion

2013-07

Publications

• Results Meier JJ, Rosenstock J, Hincelin-Mery A, Roy-Duval C, Delfolie A, Coester HV, Menge BA, Forst T, Kapitza C. Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes on Optimized Insulin Glargine With or Without Metformin: A Randomized, Open-Label Trial. Diabetes Care. 2015 Jul;38(7):1263-73. doi: 10.2337/dc14-1984. Epub 2015 Apr 17.

Drugs

Indications