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

Primary Purpose

Impaired Glucose Tolerance, Abdominal Obesity

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
GFT505 80mg
Placebo
Sponsored by
Genfit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Impaired Glucose tolerance, OGTT, PPARs

Eligibility Criteria

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

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.

Sites / Locations

  • Site n°31
  • Site n°32
  • Site n°36
  • Site n°37
  • Site n°34
  • Site n°35
  • Site n°39
  • Site n°17
  • Site n°16
  • Site n°19
  • Site n°14
  • Site n°10
  • Site n°12
  • Site n°2
  • Site n°13
  • Site n°1
  • Site n°15
  • Site n°11
  • Site n°30
  • Site n°18

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

Oral Glucose test Tolerance (OGTT)
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)
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
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
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)
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
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).

Full Information

First Posted
January 10, 2011
Last Updated
January 11, 2011
Sponsor
Genfit
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1. Study Identification

Unique Protocol Identification Number
NCT01275469
Brief Title
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genfit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Abdominal Obesity
Keywords
Impaired Glucose tolerance, OGTT, PPARs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (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
Oral Glucose test Tolerance (OGTT)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Volume oxygen maximal (VO2max)
Description
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.
Time Frame
5 weeks
Title
Respiratory parameters measured during the physical exercise test
Description
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.
Time Frame
5 weeks
Title
Fasting Glycemia and Insulinemia
Description
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.
Time Frame
5 weeks
Title
HOMA index (Homeostasis Model Assessment)
Description
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.
Time Frame
5 weeks
Title
Lipids
Description
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).
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
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
Eric BRUCKERT, Pr.
Organizational Affiliation
University Hospital of Paris 6, France
Official's Role
Study Chair
Facility Information:
Facility Name
Site n°31
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°32
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°36
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°37
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°34
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Site n°35
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Site n°39
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Site n°17
City
Briollay
ZIP/Postal Code
49125
Country
France
Facility Name
Site n°16
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Site n°19
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Site n°14
City
le MESNIL en VALLEE
ZIP/Postal Code
49410
Country
France
Facility Name
Site n°10
City
Murs-erigne
ZIP/Postal Code
49610
Country
France
Facility Name
Site n°12
City
Murs-erigne
ZIP/Postal Code
49610
Country
France
Facility Name
Site n°2
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Site n°13
City
Parcay Les Pins
ZIP/Postal Code
49390
Country
France
Facility Name
Site n°1
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Site n°15
City
Segre
ZIP/Postal Code
49500
Country
France
Facility Name
Site n°11
City
Thouars
ZIP/Postal Code
79100
Country
France
Facility Name
Site n°30
City
Tierce
ZIP/Postal Code
49125
Country
France
Facility Name
Site n°18
City
Vihiers
ZIP/Postal Code
49310
Country
France

12. IPD Sharing Statement

Citations:
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
PubMed Identifier
21816979
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.
Results Reference
derived

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

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