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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

December 13, 2010
July 12, 2011
December 2010
June 2011   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01261494 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type II Diabetes Mellitus
  • Drug: GFT505 80mg
    hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast
  • Drug: Placebo
    hard gelatin capsules,oral administration,4 capsules per day before breakfast
  • Experimental: GFT505 80mg
    Intervention: Drug: GFT505 80mg
  • Placebo Comparator: Matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Bosnia and Herzegovina,   Latvia,   Macedonia, The Former Yugoslav Republic of,   Moldova, Republic of,   Romania,   Serbia
 
NCT01261494
GFT505-210-5, 2010-021986-60
No
Product Development Department, Genfit
Genfit
Not Provided
Study Director: Rémy HANF, Development Director Genfit, France
Study Chair: Bertrand CARIOU, Pr. University Hospital of Nantes, France
Genfit
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP