MedPath

Acceptability of a Fixed Combination of Fenofibrate and Metformin

Phase 3
Completed
Conditions
Dyslipidemia/Glucose Metabolism Disorder
Registration Number
NCT00348725
Lead Sponsor
Solvay Pharmaceuticals
Brief Summary

The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
69
Inclusion Criteria
  • Patients with type 2 diabetes mellitus and dyslipidemia.
Exclusion Criteria
  • Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c โ‰ฅ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Quotation by Visual Numeric Rating Scale before and after 4-week treatment
Secondary Outcome Measures
NameTimeMethod
Assessment of safety by reporting of Adverse Events

Trial Locations

Locations (25)

Site 24

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Anzin, France

Site 5

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Le Temple de Bretagne, France

Site 25

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Vieux Conde, France

Site 26

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Quarouble, France

Site 21

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Baune, France

Site 32

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Bersee, France

Site 1

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Nort sur Erdre, France

Site 10

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St Etienne de Montluc, France

Site 2

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Nantes, France

Site 7

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Saint Aignan le Grand, France

Site 8

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Nantes, France

Site 9

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Nantes, France

Site 11

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Sautron, France

Site 30

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Saint-Amand, France

Site 33

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Thiant, France

Site 12

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Thouars, France

Site 20

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Vihiers, France

Site 13

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Parcay les Pins, France

Site 4

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Saint Herblain, France

Site 17

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Segre, France

Site 34

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Briollay, France

Site 29

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Nantes, France

Site 23

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Bachant, France

Site 27

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Denain, France

Site 28

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Denain, France

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