Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus

A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 12 Weeks in Patients With Type 2 Diabetes Mellitus. A Multicentre, Randomised, Double Blind, Placebo-Controlled Study.

This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.

And to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 for 12 weeks in patients with type 2 diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: GFT505 80mg; Drug: Placebo

Detailed Description

The study period per patient is 16-20 weeks maximum and is conducted as follows :

• Run-in period: 2 weeks or 6 weeks for patients under fibrate treatment at screening (4 weeks fibrate wash-out + 2 weeks placebo run-in);
• Treatment period: 12 weeks;
• Follow-up period: 2 weeks.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Site n°12
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Site n°11
• Latvia
  • Riga, Latvia, LV 1002
    • Site n°22
  • Riga, Latvia, LV 1004
    • Site n°21
  • Valmiera, Latvia, LV4201
    • Site n°23
• Macedonia, The Former Yugoslav Republic of
  • Bitola, Macedonia, The Former Yugoslav Republic of, 7000
    • Site n°33
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • Site n°31
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • Site n°32
• Moldova, Republic of
  • Balti, Moldova, Republic of, 3112
    • Site n°41
  • Chisinau, Moldova, Republic of, 2025
    • Site n°42
  • Chisinau, Moldova, Republic of, 2068
    • Site n°43
• Romania
  • Bucharest, Romania, 020045
    • Site n°67
  • Bucharest, Romania, 020045
    • Site n°69
  • Bucharest, Romania, 020475
    • Site n°68
  • Bihor County
    • Oradea, Bihor County, Romania, 410167
      • Site n°72
  • Buzau County
    • Buzau, Buzau County, Romania, 120203
      • Site n°66
  • Cluj County
    • Cluj Napoca, Cluj County, Romania, 400006
      • Site n°64
  • Maramures County
    • Baia Mare, Maramures County, Romania, 430123
      • Site n°65
  • Mures County
    • Targu Mures, Mures County, Romania, 540098
      • Site n°63
    • Targu Mures, Mures County, Romania, 540142
      • Site n°62
  • Prahova County
    • Ploiesti, Prahova County, Romania, 100163
      • Site n°71
    • Ploiesti, Prahova County, Romania, 100342
      • Site n°70
  • Sibiu County
    • Sibiu, Sibiu County, Romania, 550245
      • Site n°61
• Serbia
  • Belgrade, Serbia, 11000
    • Site n°52
  • Belgrade, Serbia, 11000
    • Site n°53
  • Belgrade, Serbia, 11000
    • Site n°56
  • Kragujevac, Serbia, 34000
    • Site n°54
  • Nis, Serbia, 18000
    • Site n°51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or post-menopausal female (defined as >12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening.
• Body Mass Index ≥27 and ≤45 kg/m².
• Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study.
• HbA1c ≥ 7.0% and <9.5%.
• Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years.

Exclusion Criteria:

• Type I Diabetes Mellitus.
• Blood Pressure > 160 / 95 mmHg.
• Lipid-lowering drugs such as fibrates.
• Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.
• Triglycerides (TG) > 400 mg/dL.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching placebo	Drug: Placebo; hard gelatin capsules,oral administration,4 capsules per day before breakfast
Experimental: GFT505 80mg	Drug: GFT505 80mg; hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	To evaluate after 12 weeks of oral administration of double blind treatment the change from baseline in HbA1c level achieved with GFT505 80mg versus placebo. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Glucose Tolerance Test (OGTT)	To evaluate the changes from baseline to end of treatment in OGTT parameters. Evaluation will be made prior the first treatment intake and 12 weeks after the first treatment intake.	12 weeks
Fasting Plasma Glucose	To evaluate the changes from baseline to end of treatment in fasting plasma Glucose. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).	12 weeks
Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]	To evaluate the changes from baseline to end of treatment in insulin resistance index. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).	12 weeks

Collaborators and Investigators

• Sponsor: Genfit
• Investigators: Study Chair: Bertrand CARIOU, Pr., University Hospital of Nantes, France

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): July 13, 2011
• Last Update Submitted That Met QC Criteria: July 12, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; OGTT; PPARs
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GFT505-210-5; 2010-021986-60 (EudraCT Number)