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The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

NCT01320345 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Juvenile Diabetes Research Foundation Australia

    collaborator UNKNOWN

  • Mylan Pharmaceuticals Inc

    collaborator INDUSTRY

  • University of Sydney

    lead OTHER

Principal Investigators

  • Anthony Keech, Professor · NHMRC Clinical Trials Centre, The University of Sydney

  • Alicia Jenkins, Professor · NHMRC Clinical Trials Centre, The University of Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2026-08-28
Completion
2026-12-31

Countries

  • Australia
  • Hong Kong
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320345 on ClinicalTrials.gov