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

Sponsor

Genfit (Industry)

Overall Status

Completed

CT.gov ID

NCT01275469

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Impaired Glucose Tolerance Abdominal Obesity	Drug: GFT505 80mg Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GFT505 80mg	Drug: GFT505 80mg Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.
Placebo Comparator: Matching placebo	Drug: Placebo Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.

Arm

Intervention/Treatment

Experimental: GFT505 80mg

Drug: GFT505 80mg

Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.

Placebo Comparator: Matching placebo

Drug: Placebo

Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site n°31	Angers	France	49000
2	Site n°32	Angers	France	49000
3	Site n°36	Angers	France	49000
4	Site n°37	Angers	France	49000
5	Site n°34	Angers	France	49100
6	Site n°35	Angers	France	49100
7	Site n°39	Angers	France	49100
8	Site n°17	Briollay	France	49125
9	Site n°16	Cholet	France	49300
10	Site n°19	Cholet	France	49300
11	Site n°14	le MESNIL en VALLEE	France	49410
12	Site n°10	Murs-erigne	France	49610
13	Site n°12	Murs-erigne	France	49610
14	Site n°2	Nantes	France	44093
15	Site n°13	Parcay Les Pins	France	49390
16	Site n°1	Paris	France	75013
17	Site n°15	Segre	France	49500
18	Site n°11	Thouars	France	79100
19	Site n°30	Tierce	France	49125
20	Site n°18	Vihiers	France	49310