Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment

Inclusion criteria

• Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening.
• HbA1c measured at visit 1 in the range of ≥ 7.0 and < 9.0 %.
• Stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). No other antidiabetic medications are permitted for 3 months prior to enrollment.

Exclusion criteria

• Pregnant or breast-feeding women.
• Women of childbearing potential not protected by medically approved contraceptive method of birth control.
• BMI >40kg/m2
• Diabetes other than type 2 diabetes.
• Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
• Presence or history of cancer within the past five years.
• Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
• Impaired hepatic tests, impaired renal function.
• History or evidence of clinically relevant renal or urological disorder.
• The investigator will evaluate whether there are other reasons why a patient may not participate.