Patients with Type 2 Diabetes Mellitus. MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
GENFIT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 180Wmol/L). 25. U
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate after 12 weeks of oral administrated treatment the change from baseline in HbA1c level achieved with GFT505 80mg versus placebo.;Secondary Objective: To evaluate the changes in glucose homeostasis To evaluate the changes in lipid metabolism To evaluate the changes in liver enzyme levels To evaluate the changes in inflammatory markers and other parameters To evaluate the variation in body weight To assess the safety of once-a-day administrations of oral doses of GFT505 80mg during 12 weeks.;Primary end point(s): After 12 weeks of daily administration of GFT505 80mg, compare changes vs baseline with those observed in the placebo group. Primary Endpoint: - Changes in HbA1c Secondary Endpoints: - Changes in fasting plasma Glucose - Changes in insulin resistance index (fasting insulin and HOMA-IR). - Changes in OGTT parameters (glucose, insulin and FFA at each timepoint, oral disposition index, insulin AUC, glucose AUC and FFA AUC) - Changes in Proinsulin and in Pro-insulin/insulin ratio. - Changes in Fructosamine level. - Proportion of patients that reach the target of HbA1c<6.5% and HbA1c<7%. - Changes in lipids (LDL-C, non-HDL-C,TG, HDL-C, Total Cholesterol, calculated VLDL-C, apolipoproteins). - Changes in Aminotransferases level (ALT and AST) and GGT levels. - Changes in inflammatory markers (hsCRP, haptoglobin, fibrinogen) and others parameters. - Variations in body weight. - Description of SAE, AE, physical examination, vital signs, medical history, ECG. - Description of haematological parameters, biochemical markers and urinalysis. | — |
Countries
Latvia
Outcome results
None listed