Assessment of insulin sensitivity in type 2 diabetics treated with metformin, fenofibrate and their combination - NA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

- Males or females aged from 40 to 75 years at inclusion;
- T2DM as defined by ADA criteria (fasting glucose > 7.0 mmol/L, e.g. 126 mg/dL; or OGTT glucose at 120 minutes > 11.1 mmol/L, e.g. 200 mg/dL.
- Inclusion criteria for inclusion at visit V1:
o For patients under oral antidiabetic treatment at inclusion which will be stopped during the washout period: fasting glucose = 6.0 mmol/L and/or OGTT glucose at 120 minutes = 10 mmol/L, and/or HbA1c = 6% and <9% at inclusion or during the last four months before inclusion,
o For patients which are not under oral antidiabetic treatment at inclusion, criteria are the same as randomization criteria: fasting glucose = 7.0 mmol/L, and/or OGTT glucose at 120 minutes = 11.1 mmol/L and/or HbA1c = 7% and <10% at inclusion or during the last four months before inclusion
- Plus at least one of the following biochemical abnormalities:
o Triglycerides (TG) = 150 mg/dL (= 1.69 mmol/L); and/or
o HDL-C = 40 mg/dL (= 1.03 mmol/L) for male patients or HDL-C = 50 mg/dL (= 1.29 mmol/L) for female patients;
- BMI (body mass index) > 25 kg/m² and = 40 kg/m²
- Having signed a written informed consent at inclusion.

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

Exclusion Criteria

- Unable or unwilling to comply with the protocol;
- Ongoing or past treatment with cyclosporin A or protease inhibitors (indinavir, ritonavir, saquinavir, …);
- Ongoing treatment with statins (atorvastatin, simvastatin, pravastatin, rosuvastatin…) at the date of V1
- LDL-C = 190 mg/dL (4.9 mmol/L) if no risk factor, LDL-C = 160 mg/dL (4.1 mmol/L) if a single risk factor exists or LDL-C = 130 mg/dL (3.4 mmol/L) in case of two or more risk factors;
- Proliferative retinopathy or maculopathy requiring laser therapy;
- Ongoing treatment with thiazolinediones (rosiglitazone, pioglitazone…) at the date of V1
- Ongoing treatment with insulin at the date of V1
- Reporting a change within the last 4 weeks before randomization and during the study in the medications that could interfere with the lipid profile (i.e., betablockers, diuretics, oral corticosteroids, thyroid hormones, retinoids, hormone replacement therapies)
- Patients affected with one of the following diseases or conditions:
· Chronic respiratory insufficiency, patient with medical device for sleep apnea;
· Chronic pancreatitis, or identified risk or known history of acute pancreatitis;
· Hepatic insufficiency, acute alcohol intoxication, alcoholism
· Renal insufficiency with calculated creatinine clearance = 60 mL/min
· Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction (within 3 months prior to randomization), or shock;
· Recent cerebrovascular stroke (within 3 months prior to randomization) or any other life-threatening vascular complication.