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Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

NCT00299871•Sanofi

View on ClinicalTrials.gov

Summary

To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily with chronic dosing in metformin-treated subjects with type 2 diabetes

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Males, females, age 30, - 75 years, type 2 diabetes mellitus, treated with metformin ≥1.0 g/day, at a stable dose for at least 3 months, BMI 25 - 40 kg/m2, HbA1C ≥7.0% and \<9.0%.

Exclusion Criteria

•Type 1 diabetes, pregnancy, lactation, women of childbearing potential, treatment with other antidiabetic agents than metformin, history of metabolic acidosis, hemoglobinopathy or hemolytic anemia, clinically significant medical abnormalities.

Locations (7)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Sanofi-Aventis Administrative Office

Laval, Canada

Sanofi-Aventis Administrative Office

Warsaw, Poland

Sanofi-Aventis Administrative Office

Bucharest, Romania

Sanofi-Aventis Administrative Office

Moscow, Russia

Sanofi-Aventis Administrative Office

Kiev, Ukraine

Key Dates

Start Date

February 1, 2006

Primary Completion Date

August 1, 2007

Completion Date

August 1, 2007

Last Updated

January 28, 2014

Enrollment

542

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

LIXISENATIDE (AVE0010)

DRUG

Sponsors

Lead Sponsor

Sanofi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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