Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus

A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 12 Weeks in Patients With Type 2 Diabetes Mellitus. A Multicentre, Randomised, Double Blind, Placebo-Controlled Study.

This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.

And to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 for 12 weeks in patients with type 2 diabetes mellitus.

The study period per patient is 16-20 weeks maximum and is conducted as follows :

• Run-in period: 2 weeks or 6 weeks for patients under fibrate treatment at screening (4 weeks fibrate wash-out + 2 weeks placebo run-in);
• Treatment period: 12 weeks;
• Follow-up period: 2 weeks.

Inclusion Criteria:

• Male or post-menopausal female (defined as >12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening.
• Body Mass Index ≥27 and ≤45 kg/m².
• Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study.
• HbA1c ≥ 7.0% and <9.5%.
• Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years.

Exclusion Criteria:

• Type I Diabetes Mellitus.
• Blood Pressure > 160 / 95 mmHg.
• Lipid-lowering drugs such as fibrates.
• Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.
• Triglycerides (TG) > 400 mg/dL.