A Pilot study to evaluate the Efficacy and Safety of GFT505 (80mg) 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.

GENFIT0 sites40 target enrollmentMarch 25, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: patients presenting with impaired glucose tolerance and abdominal obesity
Sponsor: GENFIT
Enrollment: 40
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

March 25, 2009

End Date

December 14, 2009

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
•1\) Provide written informed consent prior to enrolment.
•2\) Male or post\-menopausal female (defined as \>12 months since last menstrual period and with stable (at least 6 months prior to screening) and continuous Hormonal Replacement Therapy or surgical menopause).
•3\) Aged from 18 to 75 years. According to local regulations, Tunisian patients should be aged from 20 to 75 years.
•4\) Waist circumference \=94cm for male, \= 80cm for female.
•5\) 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 (documented in the patient file), and/or analysed the day after visit V1 (B1 lab).
•\* a tolerance of 10% for the lower limit is authorised.
•6\) Patients without previous experience of CVD\*\*.
•\*\* Cardiovascular disease will be defined as:
•1\) Peripheral Artery Disease

•Patients presenting with any of the following exclusion criteria will not be included in the trial:
•1\) Body Mass Index (BMI) \= 40 kg/m².
•2\) Weight change (variation \>5%) within 6 months at least prior to screening.
•3\) Known Heart Failure (Grade I to IV of NYHA classification).
•4\) Blood Pressure \> 160 / 95 mmHg.
•5\) Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 3 alcoholic beverages per day is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer.
•6\) Known Type I or type II Diabetes Mellitus.
•7\) Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease.
•8\) Any serious medical condition that prevent participants from adhering to the protocol or performing the physical exercise test safely (ie. articular symptomatology or chronic respiratory disease)
•9\) Evidence of any acute and chronic inflammatory processes