Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes
A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Low and Standard Doses of Fenofibrate in Combination With Metformin on the Lipid Profile in Patients With Type 2 Diabetes and Dyslipidemia.
1 other identifier
interventional
382
3 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 5, 2006
CompletedFirst Posted
Study publicly available on registry
July 6, 2006
CompletedSeptember 3, 2007
August 1, 2007
July 5, 2006
August 31, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in fasting triglycerides.
Secondary Outcomes (1)
Assessment of lipid and glucose metabolisms.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
You may not qualify if:
- Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Site 201
Katowice, Poland
Site 203
Katowice, Poland
Site 202
Warsaw, Poland
Site 204
Zabrze, Poland
Site 111
Dnipropetrovsk, Ukraine
Site 113
Dnipropetrovsk, Ukraine
Site 108
Kharkiv, Ukraine
Site 109
Kharkiv, Ukraine
Site 101
Kyiv, Ukraine
Site 102
Kyiv, Ukraine
Site 103
Kyiv, Ukraine
Site 104
Kyiv, Ukraine
Site 105
Kyiv, Ukraine
Site 106
Kyiv, Ukraine
Site 107
Kyiv, Ukraine
Site 112
Zaporizhya, Ukraine
Site 35
Acomb, United Kingdom
Site 21
Atherstone, United Kingdom
Site 14
Balsall Common, United Kingdom
Site 32
Bangor, United Kingdom
Site 23
Barry, United Kingdom
Site 36
Basingstoke, United Kingdom
Site 8
Bexhill-on-Sea, United Kingdom
Site 20
Camberley, United Kingdom
Site 22
Chesterfield, United Kingdom
Site 10
Chippenham, United Kingdom
Site 13
Coventry, United Kingdom
Site 31
Doncaster, United Kingdom
Site 15
Downpatrick, United Kingdom
Site 17
Ely, United Kingdom
Site 4
Ely, United Kingdom
Site 11
Fife, United Kingdom
Site 1
Frome, United Kingdom
Site 16
Harrow, United Kingdom
Site 5
Hastings, United Kingdom
Site 26
Haverfordwest, United Kingdom
Site 19
Keresley End, United Kingdom
Site 9
Kingswood, United Kingdom
Site 25
Newtownabbey, United Kingdom
Site 33
Northampton, United Kingdom
Site 28
Odiham, United Kingdom
Site 3
Paignton, United Kingdom
Site 12
Peterborough, United Kingdom
Site 7
Randalstown, United Kingdom
Site 27
Slough, United Kingdom
Site 6
Soham, United Kingdom
Site 2
South Glamorgan, United Kingdom
Site 34
Stratford-upon-Avon, United Kingdom
Site 29
Swindon, United Kingdom
Site 30
Trowbridge, United Kingdom
Site 18
Yaxley, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 5, 2006
First Posted
July 6, 2006
Study Start
January 1, 2004
Last Updated
September 3, 2007
Record last verified: 2007-08