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

Impaired Glucose Tolerance Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275469
• Other study ID #: GFT505-209-4
• Secondary ID: 2009-011003-23
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2011
• Last updated: January 11, 2011
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2011
• Source: Genfit
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Glucose Intolerance
• Impaired Glucose Tolerance
• Obesity
• Obesity, Abdominal

Intervention

Drug:
• GFT505 80mg
Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.
• Placebo
Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.

Locations

Country	Name	City	State
France	Site n°31	Angers
France	Site n°32	Angers
France	Site n°34	Angers
France	Site n°35	Angers
France	Site n°36	Angers
France	Site n°37	Angers
France	Site n°39	Angers
France	Site n°17	Briollay
France	Site n°16	Cholet
France	Site n°19	Cholet
France	Site n°14	le MESNIL en VALLEE
France	Site n°10	Murs-erigne
France	Site n°12	Murs-erigne
France	Site n°2	Nantes
France	Site n°13	Parcay Les Pins
France	Site n°1	Paris
France	Site n°15	Segre
France	Site n°11	Thouars
France	Site n°30	Tierce
France	Site n°18	Vihiers

Sponsors (1)

Lead Sponsor	Collaborator
Genfit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	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.	5 weeks	No
Secondary	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.	5 weeks	No
Secondary	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.	5 weeks	No
Secondary	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.	5 weeks	No
Secondary	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).	5 weeks	No