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

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00299871

Purpose

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	Drug: AVE0010	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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.

Estimated Enrollment:	500
Study Start Date:	February 2006
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299871

Locations

United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Brazil
Sanofi-Aventis
Sao Paulo, Brazil
Canada
Sanofi-Aventis
Laval, Canada
Poland
Sanofi-aventis
Warszawa, Poland
Romania
Sanofi-aventis
Bucuresti, Romania
Russian Federation
Sanofi-aventis
Moscow, Russian Federation
Ukraine
Sanofi-aventis
Kiev, Ukraine

Sponsors and Collaborators

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	DRI6012, AVE0010
Study First Received:	March 6, 2006
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00299871
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Brazil: National Health Surveillance Agency

Keywords provided by Sanofi-Aventis:

Type 2 diabetes

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on January 16, 2009