Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Status Completed

Clinical Trial Summary

Primary Objective:

• To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

• To assess the effects of lixisenatide over 24 weeks on :

• percentage of patients reaching HbA1c<7% or ≤6.5%,

• 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,

• fasting plasma glucose (FPG),

• change in 7-point self-monitored plasma glucose (SMPG) profile),

• body weight,

• change in daily basal insulin dose.

• To assess lixisenatide safety and tolerability.

• To assess anti-lixisenatide antibody development.

Clinical Trial Description

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT01632163
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Completion date: May 2015