Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

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.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00349128

Enrollment

382

Registered

2006-07-06

Start date

2004-01-31

Completion date

Unknown

Last updated

2007-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia/Glucose Metabolism Disorder

Keywords

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

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.

Interventions

DRUGfenofibrate and metformin combination (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in fasting triglycerides.	—

Secondary

Measure	Time frame
Assessment of lipid and glucose metabolisms.	—

Countries

Poland, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026