NCT01261494

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-12-16
• Last updated: 2011-07-13

Locations

28 sites across 6 countries: Bosnia and Herzegovina, Latvia, Moldova, North Macedonia, Romania, Serbia