Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity

September 21, 2012 updated by: Genfit

A Pilot Study to Evaluate the Efficacy of GFT505 (80mg) Orally Administered Once Daily for 8 Weeks on Insulin Sensitivity Using a Glucose Clamp Technique and Safety in Male Patients With Insulin Resistance and Abdominal Obesity. A Multicentre, Randomised, Single Blind, Placebo-Controlled, Cross Over Study.

The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at 80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be made using a glucose clamp technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study period per patient is 26 weeks: a selection period will precede a 8-week treatment period, a 6-week wash out period, a second 8-week treatment period in the second arm of treatment and a 2- week follow-up period.

Schedule:

  • Selection visit prior to treatment period (D-14 and D-1)
  • D0 : randomisation visit
  • Period T1: first period of treatment with GFT505 80mg or placebo for 8 weeks (D1 to D56)
  • Wash out period for 6 weeks (D57 to D98)
  • Period T2: second period of treatment with GFT505 80mg or placebo for 8 weeks (D99 to D154)
  • Follow up period for 2 weeks (D155 to D169)

Study Type

Interventional

Enrollment (Actual)

22

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
      • Nantes Cedex 1, France, 44093
        • Site n°1
      • Pierre Bénite, France, 69310
        • Site n°2

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

Male

Description

Inclusion Criteria:

  • Waist circumference ≥94cm.
  • Body Mass Index ≤ 45kg/m2.
  • Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) > 3.

Exclusion Criteria:

  • Blood Pressure > 160 / 95 mmHg.
  • Diabetes mellitus 1 or 2.
  • Historical of bariatric surgery.
  • Patient treated with a lipid-decreasing medication.
  • A fasting plasma triglycerides concentration > 400mg/dL or a plasma Low Density Lipoprotein Cholesterol (LDL-c)concentration > 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: Crossover Assignment
  • Masking: Single

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
Glucose Infusion Rate (GIR)
Time Frame: 8 weeks
To evaluate in each patient the differences in Glucose Infusion Rate (GIR) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Hepatic Glucose Production (HGP) in each patient
Time Frame: 8 weeks
To evaluate in each patient the differences in Hepatic Glucose Production (HGP) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design.
8 weeks
Changes in GIR (Glucose Infusion Rate)
Time Frame: 8 weeks
To compare the changes from baseline to endpoint in Glucose Infusion Rate (GIR). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period.
8 weeks
Changes in HGP (Hepatic Glucose Production)
Time Frame: 8 weeks
To compare the changes from baseline to endpoint in Hepatic Glucose Production (HGP). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period.
8 weeks

Collaborators and Investigators

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

Sponsor

Genfit

Investigators

  • Study Chair: Bertrand CARIOU, Pr., University Hospital of Nantes, 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

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 21, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFT505-210-6
  • 2010-023219-32 (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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