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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genfit
ClinicalTrials.gov Identifier:
NCT01271777
First received: January 4, 2011
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
Abdominal Obesity
 Drug: GFT505 80mg
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genfit:

Primary Outcome Measures:
  • Glucose Infusion Rate (GIR) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Differences in Hepatic Glucose Production (HGP) in each patient [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes in GIR (Glucose Infusion Rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes in HGP (Hepatic Glucose Production) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271777

Locations
France
Site n°1
Nantes Cedex 1, France, 44093
Site n°2
Pierre Bénite, France, 69310
Sponsors and Collaborators
Genfit
Investigators
Study Director: Rémy Hanf, Development Director Genfit, France
Study Chair: Bertrand CARIOU, Pr. University Hospital of Nantes, France
  More Information

No publications provided

Responsible Party: Genfit
ClinicalTrials.gov Identifier: NCT01271777     History of Changes
Other Study ID Numbers: GFT505-210-6, 2010-023219-32
Study First Received: January 4, 2011
Last Updated: September 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Genfit:
Pre-diabetes
Clamp technique
PPARs
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Obesity, Abdominal
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013