Status:
COMPLETED
Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Genfit
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 tole...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01261494
Start Date
December 1 2010
End Date
June 1 2011
Last Update
July 13 2011
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Site n°12
Banja Luka, Bosnia and Herzegovina, 78000
2
Site n°11
Sarajevo, Bosnia and Herzegovina, 71000
3
Site n°22
Riga, Latvia, LV 1002
4
Site n°21
Riga, Latvia, LV 1004