GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

NCT00763815 · Completed

Last updated 2026-05-28

This clinical trial is testing whether adding the medication lixisenatide to pioglitazone helps lower blood sugar levels in adults with type 2 diabetes over a 24-week period.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 484 people

Who can join Ages 18+ · all sexes

Timeline Started 2008-09 · est. completion 2011-06

Where 150 sites · Austria, Canada, France, Germany, Greece, Guatemala, India, Mexico, Peru, Puerto Rico, Romania, Turkey (Türkiye), United States

What this study is testing ClinicalTrials.gov NCT00763815 ↗

Description as written by the study sponsor.

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \[HOMA-beta\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Treatments tested

Lixisenatide (AVE0010) Drug

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
Placebo Drug

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector also known as OptiClik® Device
Pioglitazone Drug

Dose to be kept stable.
Metformin Drug

Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Main thing measured	Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Sponsor	Sanofi
Conditions studied	Diabetes Mellitus Type 2
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00763815 ↗