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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: GFT505 80mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Cardiovascular Diseases, PPARs, OGTT