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