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

Phase 2

Completed

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: GFT505 80mg; Drug: Placebo

• Registration Number: NCT01261494
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-12
• Last Update Posted: 2011-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFT505 80mg	GFT505 80mg	-
Matching placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1c	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

Name	Time	Method
Oral Glucose Tolerance Test (OGTT)	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.
Fasting Plasma Glucose	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).
Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]	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).

Trial Locations

Locations (28)

Site n°11; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Site n°23; 🇱🇻 Valmiera, Latvia

Site n°42; 🇲🇩 Chisinau, Moldova, Republic of

Site n°53; 🇷🇸 Belgrade, Serbia

Site n°41; 🇲🇩 Balti, Moldova, Republic of

Site n°43; 🇲🇩 Chisinau, Moldova, Republic of

Site n°71; 🇷🇴 Ploiesti, Prahova County, Romania

Site n°70; 🇷🇴 Ploiesti, Prahova County, Romania

Site n°69; 🇷🇴 Bucharest, Romania

Site n°12; 🇧🇦 Banja Luka, Bosnia and Herzegovina

Site n°22; 🇱🇻 Riga, Latvia

Site n°32; 🇲🇰 Skopje, Macedonia, The Former Yugoslav Republic of

Site n°21; 🇱🇻 Riga, Latvia

Site n°33; 🇲🇰 Bitola, Macedonia, The Former Yugoslav Republic of

Site n°31; 🇲🇰 Skopje, Macedonia, The Former Yugoslav Republic of

Site n°72; 🇷🇴 Oradea, Bihor County, Romania

Site n°66; 🇷🇴 Buzau, Buzau County, Romania

Site n°64; 🇷🇴 Cluj Napoca, Cluj County, Romania

Site n°63; 🇷🇴 Targu Mures, Mures County, Romania

Site n°62; 🇷🇴 Targu Mures, Mures County, Romania

Site n°65; 🇷🇴 Baia Mare, Maramures County, Romania

Site n°61; 🇷🇴 Sibiu, Sibiu County, Romania

Site n°67; 🇷🇴 Bucharest, Romania

Site n°68; 🇷🇴 Bucharest, Romania

Site n°52; 🇷🇸 Belgrade, Serbia

Site n°56; 🇷🇸 Belgrade, Serbia

Site n°54; 🇷🇸 Kragujevac, Serbia

Site n°51; 🇷🇸 Nis, Serbia