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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00703755
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : June 25, 2008
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
The purpose of this study was to study the effect of different combinations of fenofibrate and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to determine the dose combination allowing normalization of MetS patients.

Condition or disease Intervention/treatment Phase
Patients With Metabolic Syndrome Drug: Fenofibrate /Metformin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2288 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
Study Start Date : March 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)

Experimental: 2 Drug: Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)

Experimental: 3 Drug: Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)

Experimental: 4 Drug: Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)

Experimental: 5 Drug: Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)

Experimental: 6 Drug: Fenofibrate /Metformin
fenofibrate placebo + metformin 850 mg bid (F0-M1700)

Placebo Comparator: 7 Drug: Placebo

Primary Outcome Measures :
  1. 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) [ Time Frame: End of study visit (V4) ]

Secondary Outcome Measures :
  1. Fasting blood insulin and fasting blood glucose, HbA1c. [ Time Frame: End of study visit (V4) ]
  2. Area under the curve from 0 to 2h (AUC0-2h) of glucose, insulin, C-peptide and free fatty acids (FFA) during Oral Glucose Tolerance Test (OGTT). [ Time Frame: End of study visit (V4) ]
  3. Insulin sensitivity assessed by the OGTT-derived composite whole-body Insulin Sensitivity Index (ISI) [ Time Frame: End of study visit (V4) ]
  4. Fasting lipid parameters: FFA, TG, TC, HDL-C, measured LDL-C, VLDL-C, small dense LDL, apolipoprotein (Apo) A1, Apo A2, Apo CIII, LDL and HDL sizes, remna [ Time Frame: End of study visit (V4) ]
  5. Plasminogen -1 Activation Inhibitor (PAI-1) activity, PAI-1 antigen, tissue-type Plasminogen Activator antigen (t-PA-ag), high sensitivity C-reactive protein (hsCRP), fibrinogen, tumor necrosing factor (TNF) alpha, interleukin (IL)1 and IL6. [ Time Frame: End of study visit (V4) ]
  6. Body mass index (BMI), waist circumference, hip circumference, waist to hip ratio, and blood pressure. [ Time Frame: End of study visit (V4) ]
  7. Percentage of patients who presented 0, 1, 2, 3, 4 or 5 MetS criteria. [ Time Frame: End of study visit (V4) ]
  8. Adverse events (AEs). [ Time Frame: End of study visit (V4) ]
  9. Biochemistry: creatinine phosphokinase (CPK), AST, ALT, GGT, alkaline phosphatase, serum creatinine, total bilirubin, blood urea nitrogen (BUN), uric acid, albumin and total homocysteine [ Time Frame: End of study visit (V4) ]
  10. Hematology: white blood cells (WBC) and differential count, red blood cells (RBC), hemoglobin, hematocrit and platelets. [ Time Frame: End of study visit (V4) ]
  11. Blood pressure. [ Time Frame: End of study visit (V4) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00703755

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Sponsors and Collaborators
Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
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Responsible Party: Bruno Fraitag, Solvay Pharmaceuticals Identifier: NCT00703755    
Other Study ID Numbers: CFEN0203
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: June 25, 2008
Last Verified: June 2008
Keywords provided by Solvay Pharmaceuticals:
Metabolic Syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents