Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.

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

Details

• Lead Sponsor: Genfit

Criteria

Inclusion Criteria:

• Male or post-menopausal female.

• Waist circumference ≥94cm for male, ≥ 80cm for female.

• Fasting Plasma Glucose (FPG) between 110 and 126 mg/dl (between 6.1 and 7.0 mmol/l) within 6 months prior to the screening visit.

• 2-hour glycaemia at OGTT (2hr after a 75g oral glucose load) ≥140 mg/dL (7.8 mmol/l).

Exclusion Criteria:

• Body Mass Index (BMI) ≥ 40 kg/m².

• Blood Pressure > 160 / 95 mmHg.

• Known Type I or type II Diabetes Mellitus.

• Glycated haemoglobin (HbA1c) >7%.

• A fasting TG > 400mg/dl and a LDL-C > 220mg/dl.