A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
Overview[ - collapse ][ - ]
| Purpose | 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 | Patients With Metabolic Syndrome |
| Intervention | Drug: Fenofibrate /Metformin Drug: Fenofibrate /Metformin Drug: Fenofibrate /Metformin Drug: Fenofibrate /Metformin Drug: Fenofibrate /Metformin Drug: Fenofibrate /Metformin Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | Solvay Pharmaceuticals |
| Responsible Party | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00703755 |
| First Received | June 20, 2008 |
| Last Updated | June 24, 2008 |
| Last verified | June 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 20, 2008 |
|---|---|
| Last Updated Date | June 24, 2008 |
| Start Date | March 2003 |
| Estimated Primary Completion Date | June 2004 |
| Current Primary Outcome Measures | 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)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome. |
|---|---|
| Official Title | 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 | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Patients With Metabolic Syndrome |
| Intervention | 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 Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 2288 |
| Estimated Completion Date | June 2004 |
| Estimated Primary Completion Date | June 2004 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Canada, Finland, Hungary, Italy, Netherlands, Norway, Poland, Romania, Sweden |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00703755 |
|---|---|
| Other Study ID Numbers | CFEN0203 |
| Has Data Monitoring Committee | No |
| Information Provided By | Solvay Pharmaceuticals |
| Study Sponsor | Solvay Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals |
| Verification Date | June 2008 |
Locations[ + expand ][ + ]
| 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 020 | St. John's, Canada |
| Site 022 | St. John's, Canada |
| Site 010 | 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 204 | Budapest, Hungary |
| Site 199 | Budapest, Hungary |
| Site 193 | Budapest, Hungary |
| Site 202 | Budapest, Hungary |
| Site 191 | 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 076 | Padova, Italy |
| Site 075 | 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 113 | Oslo, Norway |
| Site 110 | Oslo, Norway |
| Site 118 | Oslo, Norway |
| Site 112 | 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 211 | Bucharest, Romania |
| Site 212 | Bucharest, Romania |
| Site 218 | Bucharest, Romania |
| Site 214 | Bucharest, Romania |
| Site 219 | Bucharest, Romania |
| Site 210 | 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 |