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

Phase 2

Completed

• Conditions: Impaired Glucose Tolerance; Abdominal Obesity
• Interventions: Drug: GFT505 80mg; Drug: Placebo

• Registration Number: NCT01275469
• Lead Sponsor: Genfit

Brief 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.

Detailed Description

The study period is 13 weeks maximum per patient : A screening period (1 to 6-weeks) will precede a 5-week double-blind treatment period and a 2-week follow-up period. The duration of the screening period will depend on the necessity to introduce a wash-out for lipid-lowering drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out from fibrates. During the screening period, patients will be asked to start or continue adequate diet and exercise.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-11
• Last Update Submitted: 2011-01-11
• Study First Posted: 2011-01-12
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFT505 80mg	GFT505 80mg	-
Matching placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Oral Glucose test Tolerance (OGTT)	4 weeks	To evaluate the change in plasma Glucose 2hr following oral glucose load from baseline to end point. Evaluation will be made during the selection period, prior any drug intake, and 4 weeks (28-34 days) after the first treatment intake.

Secondary Outcome Measures

Name	Time	Method
Volume oxygen maximal (VO2max)	5 weeks	To evaluate the efficacy of GFT505 80mg compared with placebo in improving the VO2max at physical exercise test. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.
Respiratory parameters measured during the physical exercise test	5 weeks	To describe the changes on others parameters measured during the physical exercise test : Volume carbon dioxide (VCO2), Respiratory quotient (RQ), Lactate concentration. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.
Fasting Glycemia and Insulinemia	5 weeks	To describe the changes of fasting glycaemia and insulinemia in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.
HOMA index (Homeostasis Model Assessment)	5 weeks	To describe the changes of HOMA index in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.
Lipids	5 weeks	To describe the changes in Triglycerides (TG), High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C) and non High Density Lipoprotein Cholesterol (non-HDL-C) levels in the two groups. Evaluation will be made the first day prior any drug intake, then 2-3, and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit).

Trial Locations

Locations (20)

Site n°13; 🇫🇷 Parcay Les Pins, France

Site n°15; 🇫🇷 Segre, France

Site n°1; 🇫🇷 Paris, France

Site n°36; 🇫🇷 Angers, France

Site n°37; 🇫🇷 Angers, France

Site n°31; 🇫🇷 Angers, France

Site n°32; 🇫🇷 Angers, France

Site n°35; 🇫🇷 Angers, France

Site n°34; 🇫🇷 Angers, France

Site n°17; 🇫🇷 Briollay, France

Site n°19; 🇫🇷 Cholet, France

Site n°2; 🇫🇷 Nantes, France

Site n°14; 🇫🇷 le MESNIL en VALLEE, France

Site n°10; 🇫🇷 Murs-erigne, France

Site n°12; 🇫🇷 Murs-erigne, France

Site n°39; 🇫🇷 Angers, France

Site n°11; 🇫🇷 Thouars, France

Site n°18; 🇫🇷 Vihiers, France

Site n°30; 🇫🇷 Tierce, France

Site n°16; 🇫🇷 Cholet, France