Clinical trial NCT01271777: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin Resistance
Abdominal Obesity
Keywords: Pre-diabetes
Clamp technique
PPARs
Insulin resistance
Lead sponsor: Genfit
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Glucose Infusion Rate (GIR)
timeFrame: 8 weeks
Secondary outcomes:
measure: Differences in Hepatic Glucose Production (HGP) in each patient
timeFrame: 8 weeks
measure: Changes in GIR (Glucose Infusion Rate)
timeFrame: 8 weeks
measure: Changes in HGP (Hepatic Glucose Production)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nantes Cedex 1
country: France
facility: Site n°1
city: Pierre Bénite
country: France
facility: Site n°2
Study officials:
affiliation: Genfit, France
name: Rémy Hanf, Development Director
role: STUDY_DIRECTOR
affiliation: University Hospital of Nantes, France
name: Bertrand CARIOU, Pr.
role: STUDY_CHAIR
References:
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.
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.