GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

NCT00688701 · Completed

Last updated 2026-05-28

This clinical trial tested the medication lixisenatide, a GLP-1 receptor agonist, in adults with type 2 diabetes to see how it affects blood sugar control over 12 weeks.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 361 people

Who can join Ages 18+ · all sexes

Timeline Started 2008-05 · est. completion 2009-12

Where 12 sites · Belgium, India, Israel, Japan, Mexico, Poland, Romania, Russia, South Korea, Tunisia, Ukraine, United States

What this study is testing ClinicalTrials.gov NCT00688701 ↗

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, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12. Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and 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

Main thing measured	Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Sponsor	Sanofi
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00688701 ↗