Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01320345 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

Study acronym: FAME 1 EYE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 20, 2026 (before its estimated August 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2025 to Aug 28, 2026v9 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 450 to confirmed 412
    • Study completion date: Dec 2025 to Dec 2026
    • Site details revised at 24 of 24 sites
  2. Primary completion date: Dec 2024 to Dec 2025
    • Site contacts updated at 2 of 24 sites
    v8
  3. Study sites: 23 to 24v7
  4. Primary completion date: Dec 2022 to Dec 2024
    • Study sites: 21 to 23
    • Study completion date: Jan 2025 to Dec 2025
    v6
  5. Primary completion date: Jan 2022 to Dec 2022
    • Site details revised at 7 of 21 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 16 to 21
    • Secondary endpoints: 16 to 12
    • Study description shortened, about 23 words
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 11 more changesShow less
    • Enrollment target: 300 to 450
    • Primary completion date: Sep 2014 to Jan 2022
    • Start date: Sep 2011 to Nov 3, 2016
    • Primary endpoints: 2 to 1
    • Study sites: 6 to 16
    • Study completion date: Sep 2014 to Jan 2025
    • Eligibility criteria expanded, about 336 words
    • Secondary endpoints: 7 to 16
    • Study description expanded, about 24 words
    • Collaborators: 5 to 3
    • Study title shortened, about 11 words
  3. Site contacts updated at 1 of 6 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Sydney
35 trials monitored
See 1 trial at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 1 Diabetes
886 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT01320345
Lead Sponsor University of Sydney
Collaborators: National Health and Medical Research Council, Australia, Juvenile Diabetes Research Foundation Australia, Mylan Pharmaceuticals Inc
Conditions
(from sponsor)		 Type 1 Diabetes Mellitus, Diabetic Retinopathy, Diabetic Nephropathies
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetic Nephropathies, Diabetic Retinopathy, Retinal Diseases
Enrollment 412 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov