A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.

Inclusion Criteria: * Male or female patients aged from 18 to 75 years old (at inclusion V1). * With 3 of the following 5 criteria, including at least 2 biochemical abnormalities (glucose and one lipid abnormality) * And having signed a written informed consent (at inclusion V1). Exclusion Criteria: * known Type 1 diabetes, or treated type 2 diabetes \[25\], \[26\]; * wth HbA1c \> 8 % \[27\] at the first blood sample; * body mass index (BMI) \> 45 kg/m2; * females who were not surgically sterilized or not using adequate contraceptive or not using adequate contraceptive precautions or not postmenopausal * pregnant or lactating women; * known hypersensitivity to fibrates; * known hypersensitivity to metformin chlorhydrate; known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level; * having received an investigational drug in the last 30 days before the date of randomization; * unable or unwilling to comply with the protocol; * likely to withdraw from the study before its completion; * treated with some concomitant medications: * reporting a change within the last 6 weeks before randomization and during the study in the medications that could interfere with the lipid profile (i.e., anti-hypertensive drugs, oral corticosteroids, thyroid hormones, retinoids, thiazidic derivatives, hormone replacement therapies); * presenting with the following disease or conditions: * chronic respiratory insufficiency, patient with medical device for sleep apnea; * current chronic pancreatitis, or identified risk or known history of acute pancreatitis; * hepatic insufficiency, acute alcohol intoxication, alcoholism; * known cholelithiasis without cholecystectomy; * aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 times the upper limit normal (ULN); * musculoskeletal disease or increased creatine phosphokinase (CPK) \> 3 times the ULN; * renal failure or renal dysfunction defined by serum creatinine levels \> 135 μmol/L in males and \> 110 μmol/L in females \[28\]; * acute conditions with the potential to alter renal function such as dehydration, severe infection, shock or intravascular administration of iodinated contrast agents; * acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction (within 3 months prior to randomization), shock; * known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomization capable of modifying the intestinal absorption of the drugs; * any other severe pathology such as cancer, mental illness, etc., which in the opinion of the investigator might pose a risk to the patient or confound the results of the study