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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poxel SA

Criteria

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