Dyslipidemia/Glucose Metabolism DisorderPhase 3NCT00362323

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

A Phase 3 study testing fenofibrate (F) + metformin (M) hydrochloride fixed combination and Metformin in people with Dyslipidemia/Glucose Metabolism Disorder, run by Solvay Pharmaceuticals at 70 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dyslipidemia/Glucose Metabolism Disorder
What is being tested?: fenofibrate (F) + metformin (M) hydrochloride fixed combination and Metformin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 482 participants
Where: 70 sitesin 7 countries
Study dates: Oct 2006to Mar 2009
Phase: Phase 3
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

Inclusion Criteria Patient with Type 2 Diabetes treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment.

Exclusion Criteria Type 1 diabetes.

Trial locations and contacts

70 sites in 7 countries.

Country

City, postcode or hospital

70 sites in 7 countries

Poland22 sites

C LF23-0121 06 01 Site 600
Bialystok
C LF23-0121 06 01 Site 613
Bydgoszcz
C LF23-0121 06 01 Site 618
Grudziądz
C LF23-0121 06 01 Site 603
Katowice
C LF23-0121 06 01 Site 601
Krakow
C LF23-0121 06 01 Site 607
Krakow
C LF23-0121 06 01 Site 610
Krakow
C LF23-0121 06 01 Site 615
Kutno
C LF23-0121 06 01 Site 605
Olsztyn
C LF23-0121 06 01 Site 604
Opole
C LF23-0121 06 01 Site 606
Poznan
C LF23-0121 06 01 Site 609
Poznan
C LF23-0121 06 01 Site 621
Sliwinska
C LF23-0121 06 01 Site 617
Starogard Gdański
C LF23-0121 06 01 Site 616
Szczecin
C LF23-0121 06 01 Site 602
Warsaw
C LF23-0121 06 01 Site 608
Warsaw
C LF23-0121 06 01 Site 619
Warsaw
C LF23-0121 06 01 Site 620
Warsaw
C LF23-0121 06 01 Site 611
Wroclaw
C LF23-0121 06 01 Site 612
Wroclaw
C LF23-0121 06 01 Site 614
Zgierz

Other trials in Poland

India16 sites

C LF23-0121 06 01 Site 501
Bangalore
C LF23-0121 06 01 Site 504
Bangalore
C LF23-0121 06 01 Site 516
Bangalore
C LF23-0121 06 01 Site 519
Bangalore
C LF23-0121 06 01 Site 508
Chennai
C LF23-0121 06 01 Site 510
Chennai
C LF23-0121 06 01 Site 505
Hyderabad
C LF23-0121 06 01 Site 509
Hyderabad
C LF23-0121 06 01 Site 517
Hyderabad
C LF23-0121 06 01 Site 511
Karnataka
C LF23-0121 06 01 Site 512
Maharashtra
C LF23-0121 06 01 Site 502
Mumbai
C LF23-0121 06 01 Site 503
Mumbai
C LF23-0121 06 01 Site 518
Nashik
C LF23-0121 06 01 Site 506
Pune
C LF23-0121 06 01 Site 514
Tiruvanathapuram-Kerala

Other trials in India

Czechia9 sites

C LF23-0121 06 01 Site107
Brno
C LF23-0121 06 01 Site108
Holešov
C LF23-0121 06 01 Site101
Karlovy Vary
C LF23-0121 06 01 Site106
Olomouc
C LF23-0121 06 01 Site109
Olomouc
C LF23-0121 06 01 Site103
Pardubice
C LF23-0121 06 01 Site102
Prague
C LF23-0121 06 01 Site104
Prague
C LF23-0121 06 01 Site105
Prague

Other trials in Czechia

Hungary9 sites

C LF23-0121 06 01 Site 406
Balatonfüred
C LF23-0121 06 01 Site 400
Budapest
C LF23-0121 06 01 Site 401
Budapest
C LF23-0121 06 01 Site 402
Budapest
C LF23-0121 06 01 Site 403
Budapest
C LF23-0121 06 01 Site 405
Budapest
C LF23-0121 06 01 Site 407
Budapest
C LF23-0121 06 01 Site 408
Budapest
C LF23-0121 06 01 Site 404
Debrecen

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France7 sites

C LF23-0121 06 01 Site 204
Bailleul
C LF23-0121 06 01 Site 200
Bondy
C LF23-0121 06 01 Site 207
Cholet
C LF23-0121 06 01 Site 208
Évreux
C LF23-0121 06 01 Site 201
Pantin
C LF23-0121 06 01 Site 202
Tours
C LF23-0121 06 01 Site 205
Wattrelos

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Slovakia4 sites

C LF23-0121 06 01 Site 700
Bratislava
C LF23-0121 06 01 Site 703
Košice
C LF23-0121 06 01 Site 702
Lučenec
C LF23-0121 06 01 Site 701
Skalica

Other trials in Slovakia

Lithuania3 sites

C LF23-0121 06 01 Site 800
Vilnius
C LF23-0121 06 01 Site 801
Vilnius
C LF23-0121 06 01 Site 802
Vilnius

Other trials in Lithuania

About this study

Official title: A Randomized, Double-blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.

Conditions: Dyslipidemia/Glucose Metabolism Disorder
Being tested: fenofibrate (F) + metformin (M) hydrochloride fixed combination, Metformin
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Medical subject headings: Dyslipidemias, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fenofibrate (F) + metformin (M) hydrochloride fixed combinationDrug
F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks
MetforminDrug
500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks

Study groups in NCT00362323
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
2	Active comparator	Not described Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

TG / HDL-C ratio
Measured: 24 weeks

Secondary outcomes (1)

Lipid and glycemic parameters
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Mar 2009

First posted10 Aug 2006 (estimated)
Study startOct 2006
Primary completionAug 2008
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dyslipidemia/Glucose Metabolism DisorderStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 482 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00362323
Sponsor's protocol ID: C LF23-0121 06 01
Other IDs: 2006-000924-15
Status last verified: Apr 2010
First submitted: 9 Aug 2006
Last updated: 16 Apr 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.
ClinicalTrials.gov ID: NCT00362323
Acronym / sponsor ID: C LF23-0121 06 01
Conditions: Dyslipidemia/Glucose Metabolism Disorder
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 482 participants (actual)
Lead sponsor: Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Aug 2008 (actual)
Study completion: Mar 2009 (actual)
First posted: 10 Aug 2006 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
2	Active comparator	Drug: Metformin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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 (F) + metformin (M) hydrochloride fixed combinationF80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks	Drug	1
Metformin500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks	Drug	2

Primary outcome

TG / HDL-C ratio
Time frame: 24 weeks

1 secondary outcome

Lipid and glycemic parameters
Time frame: 24 weeks

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 16 Apr 2010.

Related trials for Dyslipidemia/Glucose Metabolism Disorder

Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
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Metabolic Syndrome, Insulin Resistance
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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.

Michel Conte study director

Solvay Pharmaceuticals

70 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 16 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in Poland, India, Czechia, Hungary, France and 2 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

TG / HDL-C ratio (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00362323.

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 16 Apr 2010.