Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

• Status: Completed
• Trial end date: 2018-11-17

Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.

Secondary Objectives:

To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes.

To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Dulaglutide; Exenatide; Glucagon-Like Peptide 1; Hypoglycemic Agents; Immunoglobulin Fc Fragments; Insulin; Insulin Glargine; Insulin, Globin Zinc; Liraglutide; Lixisenatide; Metformin; Pioglitazone; rGLP-1 protein; Sodium-Glucose Transporter 2 Inhibitors