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Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

Phase 2
Completed
Conditions
Dyslipidemia/Glucose Metabolism Disorder
Registration Number
NCT00349128
Lead Sponsor
Solvay Pharmaceuticals
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
382
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in fasting triglycerides.
Secondary Outcome Measures
NameTimeMethod
Assessment of lipid and glucose metabolisms.

Trial Locations

Locations (51)

Site 201

🇵🇱

Katowice, Poland

Site 203

🇵🇱

Katowice, Poland

Site 202

🇵🇱

Warszawa, Poland

Site 204

🇵🇱

Zabrze, Poland

Site 111

🇺🇦

Dnipropetrovsk, Ukraine

Site 113

🇺🇦

Dnipropetrovsk, Ukraine

Site 108

🇺🇦

Kharkiv, Ukraine

Site 109

🇺🇦

Kharkiv, Ukraine

Site 101

🇺🇦

Kyiv, Ukraine

Site 102

🇺🇦

Kyiv, Ukraine

Scroll for more (41 remaining)
Site 201
🇵🇱Katowice, Poland

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