Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients — GetGoal Duo-2  

Type 2 Diabetes Clinical Trial

Official title: A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Status Completed

Clinical Trial Summary

Primary Objective:

• To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

• To compare the treatments/regimens on:

• The percentage of patients reaching the target of HbA1c <7% or ≤6.5%

• Body weight

• Self-Monitored Glucose profiles

• Fasting Plasma Glucose (FPG)

• Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients)

• Daily doses of insulins

• Safety and tolerability

Clinical Trial Description

Approximately 41 weeks including a 26 week treatment period ;

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT01768559
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Completion date: December 2014