Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.

This study has been completed.
Sponsor:
Information provided by:
Genfit
ClinicalTrials.gov Identifier:
NCT01275469
First received: January 10, 2011
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

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.

Resource links provided by NLM:


Further study details as provided by Genfit:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275469

Locations
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
Sponsors and Collaborators
Genfit
Investigators
Study Director: Rémy Hanf, Development Director GENFIT, France
Study Chair: Eric BRUCKERT, Pr. University Hospital of Paris 6, France
  More Information

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 July 24, 2014