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

Phase 2
18 Years
75 Years
Not Enrolling
Patients With Metabolic Syndrome

Thank you

Trial Information

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

- 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

- current chronic pancreatitis, or identified risk or known history of acute

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The percentage of normalized patients at V4 (fasting glucose < 6.1 mmol/L, TG < 1.69 mmol/L and HDL-C >= 1.03 mmol/L in males and >= 1.29 mmol/L in females)

Outcome Time Frame:

End of study visit (V4)

Safety Issue:


Principal Investigator

Global Clinical Director Solvay

Investigator Role:

Study Director

Investigator Affiliation:

Solvay Pharmaceuticals


Canada: Health Canada

Study ID:




Start Date:

March 2003

Completion Date:

June 2004

Related Keywords:

  • Patients With Metabolic Syndrome
  • Diabetes
  • Hypertriglyceridaemia
  • Metabolic Syndrome
  • Metabolic Syndrome X