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

This study has been completed.
Sponsor:
Information provided by:
Genfit
ClinicalTrials.gov Identifier:
NCT01261494
First received: December 13, 2010
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Type II Diabetes Mellitus
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 (80mg) Orally Administered Once Daily for 12 Weeks in Patients With Type 2 Diabetes Mellitus. A Multicentre, Randomised, Double Blind, Placebo-Controlled Study.

Resource links provided by NLM:


Further study details as provided by Genfit:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Oral Glucose Tolerance Test (OGTT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Fasting Plasma Glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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).

  • Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 97
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (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 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.
  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 (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.
  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: NCT01261494

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

No publications provided

Responsible Party: Product Development Department, Genfit
ClinicalTrials.gov Identifier: NCT01261494     History of Changes
Other Study ID Numbers: GFT505-210-5, 2010-021986-60
Study First Received: December 13, 2010
Last Updated: July 12, 2011
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Bosnia: Federal Ministry of Health
Macedonia: Ethics Committee
Macedonia: Ministry of Health
Moldova: Ministry of Health
Serbia: Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Genfit:
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases
PPARs
OGTT

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014