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
The primary objective is to assess the effects of AVE0010 when it is used in the morning or
in the evening on glycemic control in terms of HbA1c reduction at 24 weeks.
The secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma
glucose, and to evaluate safety and tolerability.
- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit,
insufficiently controlled with metformin
- HbA1c < 7% or >10%
- Pregnant or breastfeeding women or women of childbearing potential with no effective
- Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to
- 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.