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

Primary Purpose

Insulin Resistance, Abdominal Obesity

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

GFT505 80mg

Placebo

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Pre-diabetes, Clamp technique, PPARs, Insulin resistance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Site n°1
Site n°2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GFT505 80mg

Matching placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01271777

First Posted

January 4, 2011

Last Updated

September 21, 2012

Sponsor

Genfit

1. Study Identification

Unique Protocol Identification Number

NCT01271777

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genfit

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Abdominal Obesity

Keywords

Pre-diabetes, Clamp technique, PPARs, Insulin resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GFT505 80mg

Arm Type

Experimental

Arm Title

Matching placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

GFT505 80mg

Intervention Description

hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

hard gelatin capsules, oral administration, 4 capsules per day before breakfast

Primary Outcome Measure Information:

Title

Glucose Infusion Rate (GIR)

Description

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.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Differences in Hepatic Glucose Production (HGP) in each patient

Description

Time Frame

8 weeks

Title

Changes in GIR (Glucose Infusion Rate)

Description

Time Frame

8 weeks

Title

Changes in HGP (Hepatic Glucose Production)

Description

Time Frame

8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rémy Hanf, Development Director

Organizational Affiliation

Genfit, France

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bertrand CARIOU, Pr.

Organizational Affiliation

University Hospital of Nantes, France

Official's Role

Study Chair

Facility Information:

Facility Name

Site n°1

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Site n°2

City

Pierre Bénite

ZIP/Postal Code

69310

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

23715754

Citation

Cariou B, Hanf R, Lambert-Porcheron S, Zair Y, Sauvinet V, Noel B, Flet L, Vidal H, Staels B, Laville M. Dual peroxisome proliferator-activated receptor alpha/delta agonist GFT505 improves hepatic and peripheral insulin sensitivity in abdominally obese subjects. Diabetes Care. 2013 Oct;36(10):2923-30. doi: 10.2337/dc12-2012. Epub 2013 May 28.

Results Reference

derived

PubMed Identifier

23703580

Citation

Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.

Results Reference

derived

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

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