Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00349128

Collaborator

(none)

382

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia/Glucose Metabolism Disorder	Drug: fenofibrate and metformin combination (drug)	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2004

Outcome Measures

Primary Outcome Measures

Change in fasting triglycerides. []

Secondary Outcome Measures

Assessment of lipid and glucose metabolisms. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Site 201	Katowice	Poland
2	Site 203	Katowice	Poland
3	Site 202	Warszawa	Poland
4	Site 204	Zabrze	Poland
5	Site 111	Dnipropetrovsk	Ukraine
6	Site 113	Dnipropetrovsk	Ukraine
7	Site 108	Kharkiv	Ukraine
8	Site 109	Kharkiv	Ukraine
9	Site 101	Kyiv	Ukraine
10	Site 102	Kyiv	Ukraine
11	Site 103	Kyiv	Ukraine
12	Site 104	Kyiv	Ukraine
13	Site 105	Kyiv	Ukraine
14	Site 106	Kyiv	Ukraine
15	Site 107	Kyiv	Ukraine
16	Site 112	Zaporizhya	Ukraine
17	Site 35	Acomb	United Kingdom
18	Site 21	Atherstone	United Kingdom
19	Site 14	Balsall Common	United Kingdom
20	Site 32	Bangor	United Kingdom
21	Site 23	Barry	United Kingdom
22	Site 36	Basingstoke	United Kingdom
23	Site 8	Bexhill-on-Sea	United Kingdom
24	Site 20	Camberley	United Kingdom
25	Site 22	Chesterfield	United Kingdom
26	Site 10	Chippenham	United Kingdom
27	Site 13	Coventry	United Kingdom
28	Site 31	Doncaster	United Kingdom
29	Site 15	Downpatrick	United Kingdom
30	Site 17	Ely	United Kingdom
31	Site 4	Ely	United Kingdom
32	Site 11	Fife	United Kingdom
33	Site 1	Frome	United Kingdom
34	Site 16	Harrow	United Kingdom
35	Site 5	Hastings	United Kingdom
36	Site 26	Haverfordwest	United Kingdom
37	Site 19	Keresley end	United Kingdom
38	Site 9	Kingswood	United Kingdom
39	Site 25	Newtownabbey	United Kingdom
40	Site 33	Northampton	United Kingdom
41	Site 28	Odiham	United Kingdom
42	Site 3	Paignton	United Kingdom
43	Site 12	Petersborough	United Kingdom
44	Site 7	Randalstown	United Kingdom
45	Site 27	Slough	United Kingdom
46	Site 6	Soham	United Kingdom
47	Site 2	South Glamorgan	United Kingdom
48	Site 34	Stratford on Avon	United Kingdom
49	Site 29	Swindon	United Kingdom
50	Site 30	Trowbridge	United Kingdom
51	Site 18	Yaxley	United Kingdom