Common heart drug may shield eyes of type 1 diabetes patients

NCT ID NCT01320345

Disease control Sponsor: University of Sydney Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether fenofibrate, a drug typically used to lower blood fats, can slow the worsening of diabetic retinopathy (eye damage) in adults with type 1 diabetes. Over 400 participants take either fenofibrate or a placebo daily for three years. The goal is to see if the drug reduces the need for laser surgery or other eye treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Fenofibrate (a drug that lowers fats in the blood)
What this could lead to: If it works, fenofibrate could become a new way to slow or prevent vision loss from diabetic retinopathy in people with type 1 diabetes.
What could go wrong: This is a phase 3 trial, but results are not yet reported. Fenofibrate may not slow retinopathy enough to be useful, and it can cause side effects like muscle pain or liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

412 people

The number who actually took part.

Started

Nov 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria (for the main study): 1. Men or non-pregnant women (on acceptable contraception) with T1D\* according to standard criteria: * T1D defined as either (1) T1D diagnosed below 40 years of age and insulin therapy commencing within one year of T1D diagnosis, or (2) T1D diagnosed before, at or after 40 years of age along with: i) Documented history of ketoacidosis, and/or ii) Documented history of very low or undetectable C-peptide (fasting \<200 nmol/L or 0.2 pmol/L), and/or iii) Documented history of T1D related autoantibody/ies (anti-Glutamic acid decarboxylase, anti-A2, anti-ZnT8). 2. Age 18 years or over; 3. Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2; 4. Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy). Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.; 5. All types of insulin therapy, with no restriction by level of HbA1c; 6. Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances; 7. Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study. Eligibility criteria for the reference group is limited to age and gender matched individuals who do not have T1D. Exclusion criteria: 1. Definite indication for or contraindications to fibrate treatment (Other lipid drugs \[e.g. statins, ezetimibe, fish oils\] are allowed.); 2. Need for bilateral intra-ocular treatment or laser photocoagulation therapy within the next 3 months (this exclusion only applies to retinal laser photocoagulation treatment to the posterior pole i.e. laser correction of corneas for short-sightedness is NOT an exclusion criterion); 3. Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy; 4. Prior bilateral intra-ocular injection(s) within the last 6 months; 5. Bilateral cataract surgery within the last 6 months; 6. Planned bilateral cataract surgery within the next 12 months; 7. History of any other non-diabetic eye disease that is or is likely to affect bilateral vision; 8. History of photosensitive skin rash or myositis; 9. Abnormal thyroid function (untreated); 10. Liver function tests exceeding 3x upper limit of normal (ULN); 11. Persistent elevated unexplained blood creatinine phosphokinase level above normal range; 12. Documented fasting triglycerides (TG) levels \>6.5 mmol/L; 13. History of pancreatitis, deep vein thrombosis (DVT) or pulmonary embolism; 14. Use of investigational drugs in the prior 8 weeks; 15. Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis; 16. Myocardial infarction (MI), unstable angina, stroke or heart failure within last 6 months; 17. Diagnosed cancer with ongoing treatment or prognosis anticipated at \<5 years; 18. Any obstacle to regular follow-up including scheduled clinic attendances; 19. Prior or planned organ transplantation (including islet cells) with subsequent continued immunosuppression therapy.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

background diabetic retinopathy diabetes mellitus diabetic kidney disease diabetic retinopathy retinal disorder type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic nephropathies Diabetic retinopathy Type 1 diabetes mellitus

Contacts and locations

Locations

Auckland Diabetes Centre

Auckland, 1051, New Zealand
Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia
Belfast Health and Social Care Trust

Belfast, BT12 6BA, United Kingdom
Cairns Hospital

Cairns, Queensland, 4870, Australia
Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia
Christchurch Hospital

Christchurch, 8011, New Zealand
Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia
Fremantle Hospital

Fremantle, Western Australia, 6160, Australia
Garvan Institute of Medical Research

Darlinghurst, New South Wales, 2010, Australia
Heidelberg Repatriation Hospital

Heidelberg, Victoria, 3081, Australia
Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia
Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia
Prince of Wales Hospital

Randwick, New South Wales, 2032, Australia
Prince of Wales Hospital

Shatin, New Territories, Hong Kong
Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia
Retina Associates - South West Retina

Liverpool, New South Wales, 2170, Australia
Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia
Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia
Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia
Southern Adelaide Diabetes and Endocrine Services

Oaklands Park, South Australia, 5046, Australia
St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia
Sunshine Hospital

St Albans, Victoria, 3021, Australia
The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia
University Hospital Geelong

Geelong, Victoria, 3220, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.