Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

NCT ID: NCT00349128

Last Updated: 2007-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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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

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Conditions

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Dyslipidemia/Glucose Metabolism Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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fenofibrate and metformin combination (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus

Exclusion Criteria

* Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 201

Katowice, , Poland

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Site 203

Katowice, , Poland

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Site 202

Warsaw, , Poland

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Site 204

Zabrze, , Poland

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Site 111

Dnipropetrovsk, , Ukraine

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Site 113

Dnipropetrovsk, , Ukraine

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Site 108

Kharkiv, , Ukraine

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Site 109

Kharkiv, , Ukraine

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Site 101

Kyiv, , Ukraine

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Site 102

Kyiv, , Ukraine

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Site 103

Kyiv, , Ukraine

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Site 104

Kyiv, , Ukraine

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Site 105

Kyiv, , Ukraine

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Site 106

Kyiv, , Ukraine

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Site 107

Kyiv, , Ukraine

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Site 112

Zaporizhya, , Ukraine

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Site 35

Acomb, , United Kingdom

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Site 21

Atherstone, , United Kingdom

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Site 14

Balsall Common, , United Kingdom

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Site 32

Bangor, , United Kingdom

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Site 23

Barry, , United Kingdom

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Site 36

Basingstoke, , United Kingdom

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Site 8

Bexhill-on-Sea, , United Kingdom

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Site 20

Camberley, , United Kingdom

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Site 22

Chesterfield, , United Kingdom

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Site 10

Chippenham, , United Kingdom

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Site 13

Coventry, , United Kingdom

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Site 31

Doncaster, , United Kingdom

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Site 15

Downpatrick, , United Kingdom

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Site 17

Ely, , United Kingdom

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Site 4

Ely, , United Kingdom

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Site 11

Fife, , United Kingdom

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Site 1

Frome, , United Kingdom

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Site 16

Harrow, , United Kingdom

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Site 5

Hastings, , United Kingdom

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Site 26

Haverfordwest, , United Kingdom

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Site 19

Keresley End, , United Kingdom

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Site 9

Kingswood, , United Kingdom

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Site 25

Newtownabbey, , United Kingdom

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Site 33

Northampton, , United Kingdom

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Site 28

Odiham, , United Kingdom

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Site 3

Paignton, , United Kingdom

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Site 12

Peterborough, , United Kingdom

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Site 7

Randalstown, , United Kingdom

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Site 27

Slough, , United Kingdom

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Site 6

Soham, , United Kingdom

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Site 2

South Glamorgan, , United Kingdom

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Site 34

Stratford-upon-Avon, , United Kingdom

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Site 29

Swindon, , United Kingdom

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Site 30

Trowbridge, , United Kingdom

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Site 18

Yaxley, , United Kingdom

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Countries

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Poland Ukraine United Kingdom

Other Identifiers

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C LF23-0121 03 01

Identifier Type: -

Identifier Source: org_study_id