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

Genfit97 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type II Diabetes Mellitus

Interventions

GFT505 80mgDRUG

hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast

PlaceboDRUG

hard gelatin capsules,oral administration,4 capsules per day before breakfast

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (28)

Site n°12

Banja Luka, Bosnia and Herzegovina

Outcomes

Primary Outcomes

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).

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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).

Time frame: 12 weeks

Data from ClinicalTrials.gov

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