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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

  Hide Study Locations
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Canada, Alberta
Site 013
Calgary, Alberta, Canada
Site 019
Calgary, Alberta, Canada
Site 007
Chicoutimi, Canada
Site 024
Halifax, Canada
Site 004
Hamilton, Canada
Site 012
Kingston, Canada
Site 017
Longueuil, Canada
Site 009
Montague, Canada
Site 001
Montreal, Canada
Site 015
Montreal, Canada
Site 003
Quebec, Canada
Site 025
Sainte Foy, Canada
Site 026
Sainte Foy, Canada
Site 021
Sherbrooke, Canada
Site 010
St. John's, Canada
Site 020
St. John's, Canada
Site 022
St. John's, Canada
Site 006
Ste-Foy, Canada
Site 016
Toronto, Canada
Site 005
Vancouver, Canada
Site 011
Victoria, Canada
Site 090
Hus, Finland
Site 091
Jakobstad, Finland
Site 095
Jyvaskyla, Finland
Site 092
Mikkeli, Finland
Site 096
Narpes, Finland
Site 094
Vaasa, Finland
Site 190
Budapest, Hungary
Site 191
Budapest, Hungary
Site 193
Budapest, Hungary
Site 199
Budapest, Hungary
Site 202
Budapest, Hungary
Site 204
Budapest, Hungary
Site 203
Debrecen, Hungary
Site 200
Gyongyos, Hungary
Site 201
Gyor, Hungary
Site 198
Gyula, Hungary
Site 197
Miskolc, Hungary
Site 196
Pecs, Hungary
Site 194
Szeged, Hungary
Site 192
Szekesfehervar, Hungary
Site 205
Szombathely, Hungary
Site 195
Veszprem, Hungary
Site 074
Catanzaro, Italy
Site 077
Chieti Scalo, Italy
Site 075
Padova, Italy
Site 076
Padova, Italy
Site 073
Palermo, Italy
Site 072
Perugia, Italy
Site 070
Treviglio Bergamo, Italy
Site 044
Almere, Netherlands
Site 040
Amsterdam Zuidoost, Netherlands
Site 054
Den Helder, Netherlands
Site 057
Dordrecht, Netherlands
Site 042
Eindhoven, Netherlands
Site 045
Groningen, Netherlands
Site 052
Groningen, Netherlands
Site 041
Hoorn, Netherlands
Site 046
Leiden, Netherlands
Site 047
Rotterdam, Netherlands
Site 051
Rotterdam, Netherlands
Site 043
Sliedrecht, Netherlands
Site 055
Tiel, Netherlands
Site 053
Veldhoven, Netherlands
Site 048
Velp, Netherlands
Site 056
Velp, Netherlands
Site 049
Zoetermeer, Netherlands
Site 060
Zwijndrecht, Netherlands
Site 117
Elverum, Norway
Site 114
Hobol, Norway
Site 111
Horten, Norway
Site 110
Oslo, Norway
Site 112
Oslo, Norway
Site 113
Oslo, Norway
Site 118
Oslo, Norway
Site 115
Skedsmokorset, Norway
Site 130
Brodnowski, Poland
Site 139
Chrzanow, Poland
Site 134
Gdansk, Poland
Site 132
Katowice, Poland
Site 131
Kielce, Poland
Site 135
Olsztyn, Poland
Site 138
Ul. Ziolowa, Poland
Site 133
Warsawa, Poland
Site 220
Brasov, Romania
Site 210
Bucharest, Romania
Site 211
Bucharest, Romania
Site 212
Bucharest, Romania
Site 214
Bucharest, Romania
Site 218
Bucharest, Romania
Site 219
Bucharest, Romania
Site 215
Cluj - Napoca, Romania
Site 213
Craiova, Romania
Site 217
Iasi, Romania
Site 216
Suceava, Romania
Site 153
Gothenburg, Sweden
Site 154
Kristianstad, Sweden
Site 150
Linkoping, Sweden
Site 155
Lund, Sweden
Site 152
Stockholm, Sweden
Site 151
Umea, Sweden
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     History of Changes
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