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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.

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patients With Metabolic Syndrome

Intervention: Fenofibrate /Metformin (Drug); Fenofibrate /Metformin (Drug); Fenofibrate /Metformin (Drug); Fenofibrate /Metformin (Drug); Fenofibrate /Metformin (Drug); Fenofibrate /Metformin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

Clinical Details

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

Primary outcome: 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)

Secondary outcome:

Fasting blood insulin and fasting blood glucose, HbA1c.

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).

Insulin sensitivity assessed by the OGTT-derived composite whole-body Insulin Sensitivity Index (ISI)

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

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.

Body mass index (BMI), waist circumference, hip circumference, waist to hip ratio, and blood pressure.

Percentage of patients who presented 0, 1, 2, 3, 4 or 5 MetS criteria.

Adverse events (AEs).

Biochemistry: creatinine phosphokinase (CPK), AST, ALT, GGT, alkaline phosphatase, serum creatinine, total bilirubin, blood urea nitrogen (BUN), uric acid, albumin and total homocysteine

Hematology: white blood cells (WBC) and differential count, red blood cells (RBC), hemoglobin, hematocrit and platelets.

Blood pressure.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Site 013, Calgary, Alberta, Canada

Site 019, Calgary, Alberta, Canada

Additional Information

Starting date: March 2003
Last updated: June 24, 2008

Page last updated: August 23, 2015

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