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ACTIVE NOT RECRUITING
NCT01320345
PHASE3

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

Sponsor: University of Sydney

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2016-11-03

Completion Date

2026-12

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

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.

Locations (24)

Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Garvan Institute of Medical Research

Darlinghurst, New South Wales, Australia

Retina Associates - South West Retina

Liverpool, New South Wales, Australia

Hunter Diabetes Centre

Merewether, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Cairns Hospital

Cairns, Queensland, Australia

Mater Adult Hospital

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Southern Adelaide Diabetes and Endocrine Services

Oaklands Park, South Australia, Australia

University Hospital Geelong

Geelong, Victoria, Australia

Heidelberg Repatriation Hospital

Heidelberg, Victoria, Australia

Baker Heart and Diabetes Institute

Melbourne, Victoria, Australia

St Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, Australia

Fremantle Hospital

Fremantle, Western Australia, Australia

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Auckland Diabetes Centre

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Belfast Health and Social Care Trust

Belfast, United Kingdom