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 sulfonylurea without or 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, relevant metabolic parameters in type 2 diabetes, and to assess safety and tolerability of AVE0010.


Criteria:

Inclusion Criteria: - Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with a sulfonylurea alone or a sulfonylurea in association with metformin Exclusion Criteria: - HbA1c < 7% or > 10% - Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method - Sulfonylurea not at a stable (unchanged) dose for at least 3 months prior to screening and less than the maximal effective dose according to local labeling - 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:

NCT00713830


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: March 16, 2018

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