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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2009

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.

Interventions

  • Drug: GFT505 80mg
    • Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.
  • Drug: Placebo
    • Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.

Arms, Groups and Cohorts

  • Experimental: GFT505 80mg
  • Placebo Comparator: Matching placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genfit
  • Provider of Information About this Clinical Study
    • Product Development Department, GENFIT
  • Overall Official(s)
    • Rémy Hanf, Development Director, Study Director, GENFIT, France
    • Eric BRUCKERT, Pr., Study Chair, University Hospital of Paris 6, France

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