Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2014-12-01

Summary

Primary Objective:

• To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

• To compare the treatments/regimens on:

• The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,

• Body weight,

• Self-Monitored Glucose profiles,

• Fasting Plasma Glucose (FPG),

• Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),

• Daily doses of insulins,

• Safety and tolerability.

• Phase: Phase 3

Details

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