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

January 11, 2011 updated by: Genfit

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Site n°31
      • Angers, France, 49000
        • Site n°32
      • Angers, France, 49000
        • Site n°36
      • Angers, France, 49000
        • Site n°37
      • Angers, France, 49100
        • Site n°34
      • Angers, France, 49100
        • Site n°35
      • Angers, France, 49100
        • Site n°39
      • Briollay, France, 49125
        • Site n°17
      • Cholet, France, 49300
        • Site n°16
      • Cholet, France, 49300
        • Site n°19
      • Murs-erigne, France, 49610
        • Site n°10
      • Murs-erigne, France, 49610
        • Site n°12
      • Nantes, France, 44093
        • Site n°2
      • Parcay Les Pins, France, 49390
        • Site n°13
      • Paris, France, 75013
        • Site n°1
      • Segre, France, 49500
        • Site n°15
      • Thouars, France, 79100
        • Site n°11
      • Tierce, France, 49125
        • Site n°30
      • Vihiers, France, 49310
        • Site n°18
      • le MESNIL en VALLEE, France, 49410
        • Site n°14

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Glucose test Tolerance (OGTT)
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume oxygen maximal (VO2max)
Time Frame: 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.
5 weeks
Respiratory parameters measured during the physical exercise test
Time Frame: 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.
5 weeks
Fasting Glycemia and Insulinemia
Time Frame: 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.
5 weeks
HOMA index (Homeostasis Model Assessment)
Time Frame: 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.
5 weeks
Lipids
Time Frame: 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).
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genfit

Investigators

  • Study Chair: Eric BRUCKERT, Pr., University Hospital of Paris 6, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (ESTIMATE)

January 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 11, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFT505-209-4
  • 2009-011003-23 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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