Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

Solvay Pharmaceuticals382 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

382

Conditions

Dyslipidemia/Glucose Metabolism Disorder

Interventions

fenofibrate and metformin combination (drug)DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (51)

Outcomes

Primary Outcomes

Change in fasting triglycerides.

Secondary Outcomes

Assessment of lipid and glucose metabolisms.

Data from ClinicalTrials.gov

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Site 201

Katowice, Poland

Site 203

Katowice, Poland

Site 202

Warsaw, 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

...and 41 more locations