Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

• Status: Completed
• Trial end date: 2013-05-01

Summary

Primary Objective:

• To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

• To assess the effect of the 2 lixisenatide regimens on:

• The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24

• Fasting Plasma Glucose (FPG)

• 7-point Self-Monitored Plasma Glucose (SMPG) profiles

• Body weight

• To assess the safety and tolerability of the 2 lixisenatide regimens

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Lixisenatide; Metformin