24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years
Public ClinicalTrials.gov record NCT00976937. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00976937
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 319 participants
Conditions and interventions
Conditions
Interventions
- Lixisenatide (AVE0010) Drug
- Lixisenatide Placebo Drug
- Pen auto-injector Device
- Sitagliptin Drug
- Sitagliptin Placebo Drug
- Metformin Drug
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2009
- Primary completion
- Feb 28, 2011
- Completion
- Feb 28, 2011
- Last update posted
- Oct 10, 2016
2009 – 2011
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 840019 | Montgomery | Alabama | 36109 | — |
| Sanofi-Aventis Investigational Site Number 840003 | Muscle Shoals | Alabama | 35661 | — |
| Sanofi-Aventis Investigational Site Number 840022 | Mesa | Arizona | 85206 | — |
| Sanofi-Aventis Investigational Site Number 840011 | Anaheim | California | 92801 | — |
| Sanofi-Aventis Investigational Site Number 840014 | Paramount | California | 90723 | — |
| Sanofi-Aventis Investigational Site Number 840027 | Redlands | California | 92374 | — |
| Sanofi-Aventis Investigational Site Number 840021 | Augusta | Georgia | 30909 | — |
| Sanofi-Aventis Investigational Site Number 840007 | Roswell | Georgia | 30076 | — |
| Sanofi-Aventis Investigational Site Number 840016 | Chicago | Illinois | 60610 | — |
| Sanofi-Aventis Investigational Site Number 840018 | Chicago | Illinois | 60616 | — |
| Sanofi-Aventis Investigational Site Number 840001 | Evansville | Indiana | 47714 | — |
| Sanofi-Aventis Investigational Site Number 840002 | Baton Rouge | Louisiana | 70808 | — |
| Sanofi-Aventis Investigational Site Number 840031 | Clarkston | Michigan | 48346 | — |
| Sanofi-Aventis Investigational Site Number 840020 | Florissant | Missouri | 63031 | — |
| Sanofi-Aventis Investigational Site Number 840006 | Butte | Montana | 59701 | — |
| Sanofi-Aventis Investigational Site Number 840026 | Perrysburg | Ohio | 43551 | — |
| Sanofi-Aventis Investigational Site Number 840004 | Medford | Oregon | 97504 | — |
| Sanofi-Aventis Investigational Site Number 840025 | Altoona | Pennsylvania | 16602 | — |
| Sanofi-Aventis Investigational Site Number 840009 | Brentwood | Tennessee | 37207 | — |
| Sanofi-Aventis Investigational Site Number 840008 | Dallas | Texas | 75230 | — |
| Sanofi-Aventis Investigational Site Number 840010 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00976937, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 10, 2016 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00976937 live on ClinicalTrials.gov.