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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 6, 2006
Last updated: January 27, 2014
Last verified: January 2014

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

Condition Intervention Phase
Type 2 Diabetes
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • HbA1c levels at baseline and endpoint (at 13 weeks).

Secondary Outcome Measures:
  • Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.

Enrollment: 542
Study Start Date: February 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts 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.
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Please refer to this study by its identifier: NCT00299871

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Warszawa, Poland
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00299871     History of Changes
Other Study ID Numbers: DRI6012
Study First Received: March 6, 2006
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Brazil: National Health Surveillance Agency

Keywords provided by Sanofi:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on October 08, 2015