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

Insulin Resistance Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271777
• Other study ID #: GFT505-210-6
• Secondary ID: 2010-023219-32
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2011
• Last updated: September 21, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: Genfit
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Insulin Resistance
• Obesity
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
France	Site n°1	Nantes Cedex 1
France	Site n°2	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Genfit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Infusion Rate (GIR)	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	No
Secondary	Differences in Hepatic Glucose Production (HGP) in each patient	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	No
Secondary	Changes in GIR (Glucose Infusion Rate)	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	No
Secondary	Changes in HGP (Hepatic Glucose Production)	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	No