MedPath

Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

Phase 2
Completed
Conditions
Dyslipidemia/Glucose Metabolism Disorder
Registration Number
NCT00349128
Lead Sponsor
Solvay Pharmaceuticals
Brief Summary

The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
382
Inclusion Criteria
  • Type 2 diabetes mellitus
Exclusion Criteria
  • Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c β‰₯ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in fasting triglycerides.
Secondary Outcome Measures
NameTimeMethod
Assessment of lipid and glucose metabolisms.

Trial Locations

Locations (51)

Site 102

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Kyiv, Ukraine

Site 201

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Katowice, Poland

Site 112

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Zaporizhya, Ukraine

Site 203

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Katowice, Poland

Site 202

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Warszawa, Poland

Site 104

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Kyiv, Ukraine

Site 105

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Kyiv, Ukraine

Site 101

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Kyiv, Ukraine

Site 103

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Kyiv, Ukraine

Site 107

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Kyiv, Ukraine

Site 20

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Camberley, United Kingdom

Site 31

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Doncaster, United Kingdom

Site 28

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Odiham, United Kingdom

Site 10

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Chippenham, United Kingdom

Site 13

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Coventry, United Kingdom

Site 17

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Ely, United Kingdom

Site 11

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Fife, United Kingdom

Site 1

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Frome, United Kingdom

Site 5

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Hastings, United Kingdom

Site 19

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Keresley end, United Kingdom

Site 204

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Zabrze, Poland

Site 111

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Dnipropetrovsk, Ukraine

Site 108

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Kharkiv, Ukraine

Site 35

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Acomb, United Kingdom

Site 21

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Atherstone, United Kingdom

Site 14

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Balsall Common, United Kingdom

Site 113

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Dnipropetrovsk, Ukraine

Site 32

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Bangor, United Kingdom

Site 23

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Barry, United Kingdom

Site 36

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Basingstoke, United Kingdom

Site 8

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Bexhill-on-Sea, United Kingdom

Site 15

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Downpatrick, United Kingdom

Site 22

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Chesterfield, United Kingdom

Site 4

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Ely, United Kingdom

Site 16

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Harrow, United Kingdom

Site 33

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Northampton, United Kingdom

Site 12

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Petersborough, United Kingdom

Site 18

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Yaxley, United Kingdom

Site 25

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Newtownabbey, United Kingdom

Site 29

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Swindon, United Kingdom

Site 26

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Haverfordwest, United Kingdom

Site 9

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Kingswood, United Kingdom

Site 3

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Paignton, United Kingdom

Site 7

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Randalstown, United Kingdom

Site 27

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Slough, United Kingdom

Site 2

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South Glamorgan, United Kingdom

Site 30

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Trowbridge, United Kingdom

Site 6

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Soham, United Kingdom

Site 34

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Stratford on Avon, United Kingdom

Site 109

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Kharkiv, Ukraine

Site 106

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Kyiv, Ukraine

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