Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

• Status: Completed
• Trial end date: 2021-03-01

Summary

Primary Objectives:

The co-primary objective of this study is:

• To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.

• To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.

Secondary Objectives:

• To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone.

• To assess the safety in each treatment group.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Globin Zinc; Lixisenatide; Metformin; Sodium-Glucose Transporter 2 Inhibitors