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.
- Conditions
- Patients with Type 2 Diabetes Mellitus.MedDRA version: 12.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2010-021986-60-LV
- Lead Sponsor
- GENFIT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
1. Provide written informed consent prior to enrolment.
2. 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.
3. Aged from 18 to 75 years.
4. BMI =27 and =45 kg/m².
5. 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.
6. Non-hypertensive or patient taking antihypertensive medication (except non-permitted medication) maintained at a stable dosage at least for 2 months prior to screening (and the stable dosage can be maintained throughout the study).
7. Patient agrees to come to following visits inside the protocol specified range.
In addition to the above criteria, these following inclusion criteria must be fulfilled according to B1 lab results:
8. HbA1c = 7.0% and <9.5%.
9. Anti-GAD negative for patients aged less than 40 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients presenting with any of the following exclusion criteria will not be included in the trial:
1. Type I Diabetes Mellitus.
2. Patients who have one or more of the following: symptoms of poorly controlled diabetes (drastic weight loss, polyuria-polydypsia) according to the investigator’s opinion, a history of diabetic ketoacidosis or hyperosmolar nonketosic coma.
3. Severe macular oedema requiring photocoagulation or specific treatment.
4. Known Heart Failure (Grade I to IV of NYHA classification).
5. Patients who had an acute cardiovascular episode within the 6 months previous to the start of the trial, or with a history of coronary angioplasty, history of stroke, TIA (Transient Ischemic Attack)], Coronary Heart Disease (Angina pectoris, history of myocardial infarction, revascularisation procedures)
6. Blood Pressure > 160 / 95 mmHg.
7. Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease.
8. Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
9. Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 3 alcoholic beverages per day is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer.
10. Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study.
11. The Patient is a female of childbearing potential, is pregnant or lactating.
12. Known intolerance or contra-indication to the list of excipients of GFT505 (Gelatin, Lactose monohydrate, Titanium dioxide, Red Iron Oxide, Magnesium Stearate).
13. Patient not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force.
14. Patient who cannot be contacted in case of emergency.
15. Any medication that may interfere with study medication absorption, distribution, metabolism or excretion or could lead to induction or inhibition of microsomial enzymes within 3 months prior to screening
16. Insulin or other anti-diabetic medication. Patients treated for less than 4 weeks
with insulin may be included in the study.
17. Lipid-lowering drugs such as fibrates.
18. Currently taking other investigational drugs or who have taken part in a clinical trial within the previous month prior to screening.
In addition to the above criteria, patient should not present any of the following exclusion criteria according to B1 lab results:
19. Fasting Plasma Glucose (FPG) = 240 mg/dL
20. TG > 400 mg/dL
21. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma glutamyltransferase (GGT) >3 X the upper limit of normal (ULN).
22. Positive screening for HBsAg or HCV
23. Uncontrolled hypothyroidism defined as TSH > 2X the upper limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to screening is permitted.
24. Significant renal disease, including nephritic syndrome, chronic renal failure (defined as creatinine clearance < 60mL/mn according to MDRD formula and serum creatinine >180Wmol/L).
25.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method