Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.
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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.
Condition | Intervention | Phase |
---|---|---|
Impaired Glucose Tolerance Abdominal Obesity |
Drug: GFT505 80mg Drug: Placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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. |
- Oral Glucose test Tolerance (OGTT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]To evaluate the change in plasma Glucose 2hr following oral glucose load from baseline to end point. Evaluation will be made during the selection period, prior any drug intake, and 4 weeks (28-34 days) after the first treatment intake.
- Volume oxygen maximal (VO2max) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]To evaluate the efficacy of GFT505 80mg compared with placebo in improving the VO2max at physical exercise test. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.
- Respiratory parameters measured during the physical exercise test [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]To describe the changes on others parameters measured during the physical exercise test : Volume carbon dioxide (VCO2), Respiratory quotient (RQ), Lactate concentration. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.
- Fasting Glycemia and Insulinemia [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]To describe the changes of fasting glycaemia and insulinemia in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.
- HOMA index (Homeostasis Model Assessment) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]To describe the changes of HOMA index in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.
- Lipids [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]To describe the changes in Triglycerides (TG), High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C) and non High Density Lipoprotein Cholesterol (non-HDL-C) levels in the two groups. Evaluation will be made the first day prior any drug intake, then 2-3, and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit).
Enrollment: | 47 |
Study Start Date: | June 2009 |
Study Completion Date: | January 2010 |
Primary Completion Date: | December 2009 (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 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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
France | |
Site n°36 | |
Angers, France, 49000 | |
Site n°35 | |
Angers, France, 49100 | |
Site n°34 | |
Angers, France, 49100 | |
Site n°37 | |
Angers, France, 49000 | |
Site n°31 | |
Angers, France, 49000 | |
Site n°39 | |
Angers, France, 49100 | |
Site n°32 | |
Angers, France, 49000 | |
Site n°17 | |
Briollay, France, 49125 | |
Site n°16 | |
Cholet, France, 49300 | |
Site n°19 | |
Cholet, France, 49300 | |
Site n°14 | |
le MESNIL en VALLEE, France, 49410 | |
Site n°12 | |
Murs-erigne, France, 49610 | |
Site n°10 | |
Murs-erigne, France, 49610 | |
Site n°2 | |
Nantes, France, 44093 | |
Site n°13 | |
Parcay Les Pins, France, 49390 | |
Site n°1 | |
Paris, France, 75013 | |
Site n°15 | |
Segre, France, 49500 | |
Site n°11 | |
Thouars, France, 79100 | |
Site n°30 | |
Tierce, France, 49125 | |
Site n°18 | |
Vihiers, France, 49310 |
Study Director: | Rémy Hanf, Development Director | GENFIT, France |
Study Chair: | Eric BRUCKERT, Pr. | University Hospital of Paris 6, France |
No publications provided by Genfit
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Product Development Department, GENFIT |
ClinicalTrials.gov Identifier: | NCT01275469 History of Changes |
Other Study ID Numbers: | GFT505-209-4, 2009-011003-23 |
Study First Received: | January 10, 2011 |
Last Updated: | January 11, 2011 |
Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Genfit:
Impaired Glucose tolerance OGTT PPARs |
Additional relevant MeSH terms:
Obesity Glucose Intolerance Obesity, Abdominal Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on October 18, 2012