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

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ClinicalTrials.gov Identifier: NCT01261494
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : July 13, 2011
Sponsor:
Information provided by:
Genfit

Brief Summary:

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 or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: GFT505 80mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : December 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    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 :
  1. Oral Glucose Tolerance Test (OGTT) [ Time Frame: 12 weeks ]
    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.

  2. Fasting Plasma Glucose [ Time Frame: 12 weeks ]
    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).

  3. Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)] [ Time Frame: 12 weeks ]
    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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261494


Locations
Show Show 28 study locations
Sponsors and Collaborators
Genfit
Investigators
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Study Director: Rémy HANF, Development Director Genfit, France
Study Chair: Bertrand CARIOU, Pr. University Hospital of Nantes, France
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Responsible Party: Product Development Department, Genfit
ClinicalTrials.gov Identifier: NCT01261494    
Other Study ID Numbers: GFT505-210-5
2010-021986-60 ( EudraCT Number )
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: July 2011
Keywords provided by Genfit:
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases
PPARs
OGTT
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases