Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

• Status: Completed
• Trial end date: 2019-11-25

Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).

Secondary Objectives:

• To assess the effects of the FRC in comparison with insulin glargine on:

• Percentage of patients reaching HbA1c targets (<7% );

• Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);

• Body weight

• Fasting Plasma Glucose (FPG);

• Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);

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

• Insulin glargine dose.

• To assess the safety and tolerability in each treatment group.

• Phase: Phase 3

Details

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