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

Genfit

Status and phase

Completed

Phase 2

Conditions

Type II Diabetes Mellitus

Treatments

Drug: GFT505 80mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01261494

2010-021986-60 (EudraCT Number)

GFT505-210-5

Details and patient eligibility

About

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.

Full 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.

Enrollment

97 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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