Clinical trial NCT00349128: Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dyslipidemia/Glucose Metabolism Disorder
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 382
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in fasting triglycerides.
Secondary outcomes:
measure: Assessment of lipid and glucose metabolisms.
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Site 201
city: Katowice
country: Poland
facility: Site 203
city: Warszawa
country: Poland
facility: Site 202
city: Zabrze
country: Poland
facility: Site 204
city: Dnipropetrovsk
country: Ukraine
facility: Site 111
city: Dnipropetrovsk
country: Ukraine
facility: Site 113
city: Kharkiv
country: Ukraine
facility: Site 108
city: Kharkiv
country: Ukraine
facility: Site 109
city: Kyiv
country: Ukraine
facility: Site 101
city: Kyiv
country: Ukraine
facility: Site 102
city: Kyiv
country: Ukraine
facility: Site 103
city: Kyiv
country: Ukraine
facility: Site 104
city: Kyiv
country: Ukraine
facility: Site 105
city: Kyiv
country: Ukraine
facility: Site 106
city: Kyiv
country: Ukraine
facility: Site 107
city: Zaporizhya
country: Ukraine
facility: Site 112
city: Acomb
country: United Kingdom
facility: Site 35
city: Atherstone
country: United Kingdom
facility: Site 21
city: Balsall Common
country: United Kingdom
facility: Site 14
city: Bangor
country: United Kingdom
facility: Site 32
city: Barry
country: United Kingdom
facility: Site 23
city: Basingstoke
country: United Kingdom
facility: Site 36
city: Bexhill-on-Sea
country: United Kingdom
facility: Site 8
city: Camberley
country: United Kingdom
facility: Site 20
city: Chesterfield
country: United Kingdom
facility: Site 22
city: Chippenham
country: United Kingdom
facility: Site 10
city: Coventry
country: United Kingdom
facility: Site 13
city: Doncaster
country: United Kingdom
facility: Site 31
city: Downpatrick
country: United Kingdom
facility: Site 15
city: Ely
country: United Kingdom
facility: Site 17
city: Ely
country: United Kingdom
facility: Site 4
city: Fife
country: United Kingdom
facility: Site 11
city: Frome
country: United Kingdom
facility: Site 1
city: Harrow
country: United Kingdom
facility: Site 16
city: Hastings
country: United Kingdom
facility: Site 5
city: Haverfordwest
country: United Kingdom
facility: Site 26
city: Keresley end
country: United Kingdom
facility: Site 19
city: Kingswood
country: United Kingdom
facility: Site 9
city: Newtownabbey
country: United Kingdom
facility: Site 25
city: Northampton
country: United Kingdom
facility: Site 33
city: Odiham
country: United Kingdom
facility: Site 28
city: Paignton
country: United Kingdom
facility: Site 3
city: Petersborough
country: United Kingdom
facility: Site 12
city: Randalstown
country: United Kingdom
facility: Site 7
city: Slough
country: United Kingdom
facility: Site 27
city: Soham
country: United Kingdom
facility: Site 6
city: South Glamorgan
country: United Kingdom
facility: Site 2
city: Stratford on Avon
country: United Kingdom
facility: Site 34
city: Swindon
country: United Kingdom
facility: Site 29
city: Trowbridge
country: United Kingdom
facility: Site 30
city: Yaxley
country: United Kingdom
facility: Site 18
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: