Patients With Metabolic SyndromePhase 2NCT00703755
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
A Phase 2 study testing Fenofibrate /Metformin in people with Patients With Metabolic Syndrome, run by Solvay Pharmaceuticals at 101 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Metabolic Syndrome
- What is being tested?
- Fenofibrate /Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,288 participants
- Where
- 101 sitesin 9 countries
- Study dates
- Mar 2003to Jun 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 24Show fewer
- 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
Trial locations and contacts
101 sites in 9 countries.
101 sites in 9 countries
Canada21 sites
Site 013
Calgary, Alberta
Site 019
Calgary, Alberta
Site 007
Chicoutimi
Site 024
Halifax
Site 004
Hamilton
Site 012
Kingston
Site 017
Longueuil
Site 009
Montague
Site 001
Montreal
Site 015
Montreal
Site 003
Québec
Site 025
Sainte-Foy
Site 026
Sainte-Foy
Site 021
Sherbrooke
Site 010
St. John's
Site 020
St. John's
Site 022
St. John's
Site 006
Ste-Foy
Site 016
Toronto
Site 005
Vancouver
Site 011
Victoria
Netherlands18 sites
Site 044
Almere Stad
Site 040
Amsterdam-Zuidoost
Site 054
Den Helder
Site 057
Dordrecht
Site 042
Eindhoven
Site 045
Groningen
Site 052
Groningen
Site 041
Hoorn
Site 046
Leiden
Site 047
Rotterdam
Site 051
Rotterdam
Site 043
Sliedrecht
Site 055
Tiel
Site 053
Veldhoven
Site 048
Velp
Site 056
Velp
Site 049
Zoetermeer
Site 060
Zwijndrecht
Hungary16 sites
Site 190
Budapest
Site 191
Budapest
Site 193
Budapest
Site 199
Budapest
Site 202
Budapest
Site 204
Budapest
Site 203
Debrecen
Site 200
Gyöngyös
Site 201
Győr
Site 198
Gyula
Site 197
Miskolc
Site 196
Pécs
Site 194
Szeged
Site 192
Székesfehérvár
Site 205
Szombathely
Site 195
Veszprém
Romania11 sites
Site 220
Brasov
Site 210
Bucharest
Site 211
Bucharest
Site 212
Bucharest
Site 214
Bucharest
Site 218
Bucharest
Site 219
Bucharest
Site 215
Cluj-Napoca
Site 213
Craiova
Site 217
Iași
Site 216
Suceava
Norway8 sites
Site 117
Elverum
Site 114
Hobol
Site 111
Horten
Site 110
Oslo
Site 112
Oslo
Site 113
Oslo
Site 118
Oslo
Site 115
Skedsmokorset
Poland8 sites
Site 130
Brodnowski
Site 139
Chrzanów
Site 134
Gdansk
Site 132
Katowice
Site 131
Kielce
Site 135
Olsztyn
Site 138
Ul. Ziolowa
Site 133
Warsaw
Italy7 sites
Site 074
Catanzaro
Site 077
Chieti Scalo
Site 075
Padova
Site 076
Padova
Site 073
Palermo
Site 072
Perugia
Site 070
Treviglio Bergamo
Finland6 sites
Site 090
Hus
Site 091
Jakobstad
Site 095
Jyväskylä
Site 092
Mikkeli
Site 096
Närpes
Site 094
Vaasa
Sweden6 sites
Site 153
Gothenburg
Site 154
Kristianstad
Site 150
Linköping
Site 155
Lund
Site 152
Stockholm
Site 151
Umeå
About this study
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.
- Conditions
- Patients With Metabolic Syndrome
- Being tested
- Fenofibrate /Metformin, Placebo
- Keywords
- Diabetes, Hypertriglyceridaemia, Metabolic Syndrome
- Medical subject headings
- Diabetes Mellitus, Hypertriglyceridemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate /MetforminDrug
fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
Fenofibrate /MetforminDrug
fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
Fenofibrate /MetforminDrug
fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
Fenofibrate /MetforminDrug
fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
Fenofibrate /MetforminDrug
fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
Fenofibrate /MetforminDrug
fenofibrate placebo + metformin 850 mg bid (F0-M1700)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fenofibrate /Metformin |
| 2 | Experimental | Not described Receives: Drug: Fenofibrate /Metformin |
| 3 | Experimental | Not described Receives: Drug: Fenofibrate /Metformin |
| 4 | Experimental | Not described Receives: Drug: Fenofibrate /Metformin |
| 5 | Experimental | Not described Receives: Drug: Fenofibrate /Metformin |
| 6 | Experimental | Not described Receives: Drug: Fenofibrate /Metformin |
| 7 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: End of study visit (V4)
Secondary outcomes (11)
Fasting blood insulin and fasting blood glucose, HbA1c.
Measured: 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).
Measured: End of study visit (V4)
Insulin sensitivity assessed by the OGTT-derived composite whole-body Insulin Sensitivity Index (ISI)
Measured: 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
Measured: 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.
Measured: End of study visit (V4)
Body mass index (BMI), waist circumference, hip circumference, waist to hip ratio, and blood pressure.
Measured: End of study visit (V4)
Percentage of patients who presented 0, 1, 2, 3, 4 or 5 MetS criteria.
Measured: End of study visit (V4)
Adverse events (AEs).
Measured: 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
Measured: End of study visit (V4)
Hematology: white blood cells (WBC) and differential count, red blood cells (RBC), hemoglobin, hematocrit and platelets.
Measured: End of study visit (V4)
Blood pressure.
Measured: End of study visit (V4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMar 2003
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703755
- Sponsor's protocol ID
- CFEN0203
- Status last verified
- Jun 2008
- First submitted
- 20 Jun 2008
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT00703755
- Acronym / sponsor ID
- CFEN0203
- Conditions
- Patients With Metabolic Syndrome
- Keywords
- Diabetes, Hypertriglyceridaemia, Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,288 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fenofibrate /Metformin |
| 2 | Experimental | Drug: Fenofibrate /Metformin |
| 3 | Experimental | Drug: Fenofibrate /Metformin |
| 4 | Experimental | Drug: Fenofibrate /Metformin |
| 5 | Experimental | Drug: Fenofibrate /Metformin |
| 6 | Experimental | Drug: Fenofibrate /Metformin |
| 7 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate /Metforminfenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700) | Drug | 1 |
| Fenofibrate /Metforminfenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000) | Drug | 2 |
| Fenofibrate /Metforminfenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700) | Drug | 3 |
| Fenofibrate /Metforminfenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000) | Drug | 4 |
| Fenofibrate /Metforminfenofibrate 2 x 40 mg bid + metformin placebo (F160-M0) | Drug | 5 |
| Fenofibrate /Metforminfenofibrate placebo + metformin 850 mg bid (F0-M1700) | Drug | 6 |
| PlaceboPlacebo | Drug | 7 |
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)
Time frame: End of study visit (V4)
11 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
101 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenofibrate /Metformin in people with Patients With Metabolic Syndrome, run by Solvay Pharmaceuticals at 101 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in Canada, Netherlands, Hungary, Romania, Norway and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2008.