24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

NCT00976937 · Completed

Last updated 2026-05-28

This study compared two diabetes medications, lixisenatide and sitagliptin, added to metformin in obese adults under 50 with type 2 diabetes to see how many achieved both good blood sugar control and significant weight loss after 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, double-blind treatment study

Participants 319 people

Who can join Ages 18–49 · all sexes

Timeline Started 2009-08 · est. completion 2011-03

Where 92 sites · Australia, Brazil, Canada, Chile, Germany, Guatemala, Mexico, Peru, Poland, Romania, Russia, Ukraine, United States

What this study is testing ClinicalTrials.gov NCT00976937 ↗

Description as written by the study sponsor.

The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index \[BMI\] greater than or equal to 30 kilogram per square meter \[kg/m\^2\]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment. The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24. Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.

Treatments tested

Lixisenatide (AVE0010) Drug

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

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

Administered orally once a day in the morning with or without food at approximately the same time each day.
Sitagliptin Placebo Drug

Administered orally once a day in the morning with or without food at approximately the same time each day.
Metformin Drug

Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

Main thing measured	Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00976937 ↗