Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2012-12-01

Summary

Primary Objective:

• The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

• To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

• Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;

• Percentage of participants reaching HbA1c <7% or ≤6.5%;

• 7-point Self-Monitored Plasma Glucose (SMPG) profile;

• Body weight;

• Insulin glargine dose

• Fasting Plasma Glucose (FPG);

• Percentage of participants requiring rescue therapy during the 24-week open label treatment period;

• To assess safety and tolerability of insulin glargine/lixisenatide FRC.

• Phase: Phase 2

Details

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