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Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Phase 3
Completed
Conditions
Dyslipidemia/Glucose Metabolism Disorder
Interventions
Registration Number
NCT00362323
Lead Sponsor
Solvay Pharmaceuticals
Brief 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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
482
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1fenofibrate (F) + metformin (M) hydrochloride fixed combination-
2Metformin-
Primary Outcome Measures
NameTimeMethod
TG / HDL-C ratio24 weeks
Secondary Outcome Measures
NameTimeMethod
Lipid and glycemic parameters24 weeks

Trial Locations

Locations (70)

C LF23-0121 06 01 Site107

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Brno, Czech Republic

C LF23-0121 06 01 Site108

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Holesov, Czech Republic

C LF23-0121 06 01 Site101

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Karlovy Vary, Czech Republic

C LF23-0121 06 01 Site106

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Olomouc, Czech Republic

C LF23-0121 06 01 Site109

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Olomouc, Czech Republic

C LF23-0121 06 01 Site103

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Pardubice, Czech Republic

C LF23-0121 06 01 Site102

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Praha, Czech Republic

C LF23-0121 06 01 Site104

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Praha, Czech Republic

C LF23-0121 06 01 Site105

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Praha, Czech Republic

C LF23-0121 06 01 Site 204

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Bailleul, France

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C LF23-0121 06 01 Site107
🇨🇿Brno, Czech Republic

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