Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia/Glucose Metabolism Disorder Dyslipidemias Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Site 201, Katowice, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate and metformin combination (drug)

Drug

Primary outcomes

Change in fasting triglycerides.

Secondary outcomes

Assessment of lipid and glucose metabolisms.

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start: 2004
First posted: Jul 6, 2006
Registry last updated: Sep 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed