Dyslipidemia/Glucose Metabolism Disorder Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 382 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Poland | Site 201 | Katowice | |
| Poland | Site 203 | Katowice | |
| Poland | Site 202 | Warszawa | |
| Poland | Site 204 | Zabrze | |
| Ukraine | 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 | |
| United Kingdom | 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 | Petersborough | |
| 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 on Avon | |
| United Kingdom | Site 29 | Swindon | |
| United Kingdom | Site 30 | Trowbridge | |
| United Kingdom | Site 18 | Yaxley |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
Poland, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in fasting triglycerides. | |||
| Secondary | Assessment of lipid and glucose metabolisms. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00362323 -
Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
|
Phase 3 | |
| Completed |
NCT00348725 -
Acceptability of a Fixed Combination of Fenofibrate and Metformin
|
Phase 3 |