Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

Condition(s) targeted: Dyslipidemia/Glucose Metabolism Disorder

Intervention: fenofibrate and metformin combination (drug) (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in fasting triglycerides.

Secondary outcome: Assessment of lipid and glucose metabolisms.

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Site 201, Katowice, Poland

Site 202, Warszawa, Poland

Site 203, Katowice, Poland

Site 204, Zabrze, Poland

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 108, Kharkiv, Ukraine

Site 109, Kharkiv, Ukraine

Site 111, Dnipropetrovsk, Ukraine

Site 112, Zaporizhya, Ukraine

Site 113, Dnipropetrovsk, Ukraine

Site 1, Frome, United Kingdom

Site 2, South Glamorgan, United Kingdom

Site 3, Paignton, United Kingdom

Site 4, Ely, United Kingdom

Site 5, Hastings, United Kingdom

Site 6, Soham, United Kingdom

Site 7, Randalstown, United Kingdom

Site 8, Bexhill-on-Sea, United Kingdom

Site 9, Kingswood, United Kingdom

Site 10, Chippenham, United Kingdom

Site 11, Fife, United Kingdom

Site 12, Petersborough, United Kingdom

Site 13, Coventry, United Kingdom

Site 14, Balsall Common, United Kingdom

Site 15, Downpatrick, United Kingdom

Site 16, Harrow, United Kingdom

Site 17, Ely, United Kingdom

Site 18, Yaxley, United Kingdom

Site 19, Keresley end, United Kingdom

Site 20, Camberley, United Kingdom

Site 21, Atherstone, United Kingdom

Site 22, Chesterfield, United Kingdom

Site 23, Barry, United Kingdom

Site 25, Newtownabbey, United Kingdom

Site 26, Haverfordwest, United Kingdom

Site 27, Slough, United Kingdom

Site 28, Odiham, United Kingdom

Site 29, Swindon, United Kingdom

Site 30, Trowbridge, United Kingdom

Site 31, Doncaster, United Kingdom

Site 32, Bangor, United Kingdom

Site 33, Northampton, United Kingdom

Site 34, Stratford on Avon, United Kingdom

Site 35, Acomb, United Kingdom

Site 36, Basingstoke, United Kingdom

Starting date: January 2004
Last updated: August 31, 2007