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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.

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ClinicalTrials.gov Identifier: NCT00703755
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : June 25, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 20, 2008
First Posted Date  ICMJE June 23, 2008
Last Update Posted Date June 25, 2008
Study Start Date  ICMJE March 2003
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2008)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00703755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2008)
  • Fasting blood insulin and fasting blood glucose, HbA1c. [ Time Frame: End of study visit (V4) ]
  • 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) ]
  • Insulin sensitivity assessed by the OGTT-derived composite whole-body Insulin Sensitivity Index (ISI) [ Time Frame: End of study visit (V4) ]
  • 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) ]
  • 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) ]
  • Body mass index (BMI), waist circumference, hip circumference, waist to hip ratio, and blood pressure. [ Time Frame: End of study visit (V4) ]
  • Percentage of patients who presented 0, 1, 2, 3, 4 or 5 MetS criteria. [ Time Frame: End of study visit (V4) ]
  • Adverse events (AEs). [ Time Frame: End of study visit (V4) ]
  • 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) ]
  • Hematology: white blood cells (WBC) and differential count, red blood cells (RBC), hemoglobin, hematocrit and platelets. [ Time Frame: End of study visit (V4) ]
  • Blood pressure. [ Time Frame: End of study visit (V4) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
Official Title  ICMJE A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Patients With Metabolic Syndrome
Intervention  ICMJE
  • Drug: Fenofibrate /Metformin
    fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
  • Drug: Fenofibrate /Metformin
    fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
  • Drug: Fenofibrate /Metformin
    fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
  • Drug: Fenofibrate /Metformin
    fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
  • Drug: Fenofibrate /Metformin
    fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
  • Drug: Fenofibrate /Metformin
    fenofibrate placebo + metformin 850 mg bid (F0-M1700)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Fenofibrate /Metformin
  • Experimental: 2
    Intervention: Drug: Fenofibrate /Metformin
  • Experimental: 3
    Intervention: Drug: Fenofibrate /Metformin
  • Experimental: 4
    Intervention: Drug: Fenofibrate /Metformin
  • Experimental: 5
    Intervention: Drug: Fenofibrate /Metformin
  • Experimental: 6
    Intervention: Drug: Fenofibrate /Metformin
  • Placebo Comparator: 7
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2008)
2288
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2004
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Finland,   Hungary,   Italy,   Netherlands,   Norway,   Poland,   Romania,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00703755
Other Study ID Numbers  ICMJE CFEN0203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruno Fraitag, Solvay Pharmaceuticals
Study Sponsor  ICMJE Solvay Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
PRS Account Solvay Pharmaceuticals
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP