NCT00349128CompletedPhase 2
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.
Solvay Pharmaceuticals51 sites in 3 countries382 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Solvay Pharmaceuticals
- Enrollment
- 382
- Locations
- 51
- Primary Endpoint
- Change in fasting triglycerides.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in fasting triglycerides.
Secondary Outcomes
- Assessment of lipid and glucose metabolisms.
Investigators
Study Sites (51)
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