The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

NCT ID: NCT01320345

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-03
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fenofibrate

145 mg tablet of fenofibrate administered daily for 36 months.

Group Type: EXPERIMENTAL

Fenofibrate

Intervention Type: DRUG

145 mg tablet of fenofibrate administered once daily for 36 months.

Placebo

Inert lactose tablet (otherwise matching active) administered daily for 36 months.

Group Type: PLACEBO_COMPARATOR

Inert lactose placebo

Intervention Type: DRUG

Insert lactose tablet matching active tablet administered once daily for 36 months.

Interventions

Fenofibrate

145 mg tablet of fenofibrate administered once daily for 36 months.

Intervention Type: DRUG

Inert lactose placebo

Insert lactose tablet matching active tablet administered once daily for 36 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Juvenile Diabetes Research Foundation Australia

UNKNOWN

Sponsor Role: collaborator

Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Keech, Professor

Role: PRINCIPAL_INVESTIGATOR

NHMRC Clinical Trials Centre, The University of Sydney

Alicia Jenkins, Professor

Role: PRINCIPAL_INVESTIGATOR

NHMRC Clinical Trials Centre, The University of Sydney

Locations

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

Countries

Australia; Hong Kong; New Zealand; United Kingdom

Other Identifiers

ACTRN12611000249954

Identifier Type: REGISTRY

Identifier Source: secondary_id

FAME0001

Identifier Type: -

Identifier Source: org_study_id