A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes

A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.

This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.

Inclusion Criteria:

1. Subject has given written informed consent
2. Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.
3. Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²
4. HbA1c criteria: ≥ 7% and ≤ 9.5%
5. Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit
6. Effective contraception for women of child bearing potential

Exclusion Criteria:

1. Any disease which in the investigator's opinion would exclude the subject from the study
2. Acute cardiovascular event within 3 months before randomization
3. Uncontrolled high blood pressure
4. Impairment of hepatic function
5. History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval
6. Pregnancy or lactation
7. Use of any non-permitted medication
8. Positive screen for viral hepatitis