Clinical trial NCT01275469: Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.
Official title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Glucose Tolerance
Abdominal Obesity
Keywords: Impaired Glucose tolerance
OGTT
PPARs
Lead sponsor: Genfit
Sponsor class: INDUSTRY
First posted: 2011-01-12
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.

Detailed description: The study period is 13 weeks maximum per patient : A screening period (1 to 6-weeks) will precede a 5-week double-blind treatment period and a 2-week follow-up period. The duration of the screening period will depend on the necessity to introduce a wash-out for lipid-lowering drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out from fibrates. During the screening period, patients will be asked to start or continue adequate diet and exercise.

Eligibility criteria: Inclusion Criteria:

* Male or post-menopausal female.
* Waist circumference ≥94cm for male, ≥ 80cm for female.
* Fasting Plasma Glucose (FPG) between 110 and 126 mg/dl (between 6.1 and 7.0 mmol/l) within 6 months prior to the screening visit.
* 2-hour glycaemia at OGTT (2hr after a 75g oral glucose load) ≥140 mg/dL (7.8 mmol/l).

Exclusion Criteria:

* Body Mass Index (BMI) ≥ 40 kg/m².
* Blood Pressure \> 160 / 95 mmHg.
* Known Type I or type II Diabetes Mellitus.
* Glycated haemoglobin (HbA1c) \>7%.
* A fasting TG \> 400mg/dl and a LDL-C \> 220mg/dl.

Primary outcomes:
measure: Oral Glucose test Tolerance (OGTT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Volume oxygen maximal (VO2max)
timeFrame: 5 weeks
measure: Respiratory parameters measured during the physical exercise test
timeFrame: 5 weeks
measure: Fasting Glycemia and Insulinemia
timeFrame: 5 weeks
measure: HOMA index (Homeostasis Model Assessment)
timeFrame: 5 weeks
measure: Lipids
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Site n°31
city: Angers
country: France
facility: Site n°32
city: Angers
country: France
facility: Site n°36
city: Angers
country: France
facility: Site n°37
city: Angers
country: France
facility: Site n°34
city: Angers
country: France
facility: Site n°35
city: Angers
country: France
facility: Site n°39
city: Briollay
country: France
facility: Site n°17
city: Cholet
country: France
facility: Site n°16
city: Cholet
country: France
facility: Site n°19
city: le MESNIL en VALLEE
country: France
facility: Site n°14
city: Murs-erigne
country: France
facility: Site n°10
city: Murs-erigne
country: France
facility: Site n°12
city: Nantes
country: France
facility: Site n°2
city: Parcay Les Pins
country: France
facility: Site n°13
city: Paris
country: France
facility: Site n°1
city: Segre
country: France
facility: Site n°15
city: Thouars
country: France
facility: Site n°11
city: Tierce
country: France
facility: Site n°30
city: Vihiers
country: France
facility: Site n°18
Study officials:
affiliation: GENFIT, France
name: Rémy Hanf, Development Director
role: STUDY_DIRECTOR
affiliation: University Hospital of Paris 6, France
name: Eric BRUCKERT, Pr.
role: STUDY_CHAIR
References:
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.
citation: Cariou B, Zair Y, Staels B, Bruckert E. Effects of the new dual PPAR alpha/delta agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.