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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Genfit

Criteria

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.