Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title: A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

Status Completed

Clinical Trial Summary

Primary Objective:

• The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin

Secondary Objectives:

• To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on:

• Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test

• Percentage of patients reaching HbA1c <7% or ≤6.5%

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

• Body weight

• Insulin glargine dose

• Fasting Plasma Glucose (FPG)

• Percentage of patients requiring rescue therapy during the 24-week open label treatment period

• To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination.

Clinical Trial Description

Approximately 27 weeks including a 24-week treatment period ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT01476475
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Completion date: December 2012