Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

• Status: Completed
• Trial end date: 2015-05-01

Summary

Primary Objective:

• To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

• To assess the effects of lixisenatide over 24 weeks on :

• percentage of patients reaching HbA1c<7% or ≤6.5%,

• 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,

• fasting plasma glucose (FPG),

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

• body weight,

• change in daily basal insulin dose.

• To assess lixisenatide safety and tolerability.

• To assess anti-lixisenatide antibody development.

• Phase: Phase 3

Details

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