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

NCT00707031 · Completed

Last updated 2026-05-28

This clinical trial compares two diabetes medications, lixisenatide and exenatide, in adults with type 2 diabetes who are already taking metformin to see how well they lower blood sugar levels over 24 weeks.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 639 people

Who can join Ages 18+ · all sexes

Timeline Started 2008-06 · est. completion 2010-11

Where 18 sites · Argentina, Austria, Brazil, Colombia, Denmark, Finland, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Puerto Rico, Russia, Spain, Sweden, United States

What this study is testing ClinicalTrials.gov NCT00707031 ↗

Description as written by the study sponsor.

The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life \[PAGI-QOL\]).

Treatments tested

Lixisenatide (AVE0010) Drug

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

Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner.
Prefilled pen injector Device
Metformin Drug

Metformin 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	exenatide, lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00707031 ↗