Expired Study
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Bridgewater, New Jersey 08807


Purpose:

The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with metformin in comparison to placebo, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of AVE0010 on glycemic control in terms of HbA1c reduction at 24 weeks. Secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, and to assess the safety and tolerability of AVE0010.


Criteria:

Inclusion Criteria: - Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with metformin Exclusion Criteria: - HbA1c < 7% or > 10% - Pregnant or breastfeeding women and women of childbearing potential with no effective contraceptive method - Metformin not at a stable (unchanged) dose of at least 1.5 g/day for at least 3 months prior to screening - Body mass index < 20 kg/m2 - Weight change of more than 5 kg during the 3 months preceding the study - Participation in any previous study with AVE0010 - Use of any investigational drug within 3 months prior to study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


NCT ID:

NCT00763451


Primary Contact:

Study Director
Clinical Sciences & Operations
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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