NCT01320345

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

A Randomised Trial to Evaluate the Efficacy on Retinopathy and Safety of Fenofibrate in Adults With Type 1 Diabetes. A Multicentre Double-blind Placebo-controlled Study in Australia and Internationally.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the potential benefits of 145 mg of daily fenofibrate in adults with type 1 diabetes mellitus and pre-existing non-proliferative diabetic retinopathy.

Detailed description

Diabetes is the most common cause of adult onset blindness. Irreversible vision loss is a most feared complication of diabetes. Fenofibrate is a blood fat lowering drug available in Australia and has been shown to reduce eye damage in people with Type 2 diabetes by 35-40%, and to prevent eye damage in Type 1 diabetic animal models. This study will evaluate the potential benefits of oral Fenofibrate 145mg once daily for average 36 months in 450 adults with Type 1 diabetes mellitus who are at high risk of eye damage.

Conditions

• Type 1 Diabetes Mellitus
• Diabetic Retinopathy
• Diabetic Nephropathies

Interventions

Type	Name	Description
DRUG	Fenofibrate	145 mg tablet of fenofibrate administered once daily for 36 months.
DRUG	Inert lactose placebo	Insert lactose tablet matching active tablet administered once daily for 36 months.

Timeline

• Start date: 2016-11-03
• Primary completion: 2026-08-28
• Completion: 2026-12-01
• First posted: 2011-03-22
• Last updated: 2026-01-20

Locations

24 sites across 4 countries: Australia, Hong Kong, New Zealand, United Kingdom