NCT01320345

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P50-P75 for phase_3

Timeline
4mo left

Started Nov 2016

Longer than P75 for phase_3

Geographic Reach
4 countries

24 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2016Dec 2026

First Submitted

Initial submission to the registry

March 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
5.6 years until next milestone

Study Start

First participant enrolled

November 3, 2016

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

9.8 years

First QC Date

March 18, 2011

Last Update Submit

January 15, 2026

Conditions

Type 1 Diabetes MellitusDiabetic RetinopathyDiabetic Nephropathies

Keywords

Diabetes MellitusType 1 Diabetes MellitusRetinopathyDiabetic NephropathyFenofibrate

Outcome Measures

Primary Outcomes (1)

  • Occurrence of clinical significant retinopathy progression.

    Comprising 2-step progression of ETDRS score (to at least moderately severe grade), clinically significant macular oedema, need for laser surgery, need for intraocular anti-VEGF or corticosteroid therapy or vitrectomy, adjudicated to be for diabetic retinopathy (DR)

    As reported throughout the study and/or annual eye assessment post-randomisation

Secondary Outcomes (12)

  • The individual components of the primary endpoint

    At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).

  • Occurrence of clinically significant macula oedema (CSME).

    As reported throughout the study

  • Need for laser surgery for DR

    As reported throughout the study

  • Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy

    As reported throughout the study

  • Visual acuity.

    At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).

  • +7 more secondary outcomes

Other Outcomes (3)

  • Lipid and lipoprotein levels

    At baseline and end of study

  • Biomarkers and molecular markers

    At baseline and end of study

  • Quality of Life questionnaire

    At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit

Study Arms (2)

Fenofibrate

EXPERIMENTAL

145 mg tablet of fenofibrate administered daily for 36 months.

Drug: Fenofibrate

Placebo

PLACEBO COMPARATOR

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

Drug: Inert lactose placebo

Interventions

FenofibrateDRUG

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

Fenofibrate
Inert lactose placeboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Age 18 years or over;
  • Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2;
  • 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.;
  • All types of insulin therapy, with no restriction by level of HbA1c;
  • Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
  • 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.

You may not qualify if:

  • Definite indication for or contraindications to fibrate treatment (Other lipid drugs \[e.g. statins, ezetimibe, fish oils\] are allowed.);
  • Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy;
  • Prior bilateral intra-ocular injection(s) within the last 6 months;
  • Bilateral cataract surgery within the last 6 months;
  • Planned bilateral cataract surgery within the next 12 months;
  • History of any other non-diabetic eye disease that is or is likely to affect bilateral vision;
  • History of photosensitive skin rash or myositis;
  • Abnormal thyroid function (untreated);
  • Liver function tests exceeding 3x upper limit of normal (ULN);
  • Persistent elevated unexplained blood creatinine phosphokinase level above normal range;
  • Documented fasting triglycerides (TG) levels \>6.5 mmol/L;
  • History of pancreatitis, deep vein thrombosis (DVT) or pulmonary embolism;
  • Use of investigational drugs in the prior 8 weeks;
  • Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis;
  • Myocardial infarction (MI), unstable angina, stroke or heart failure within last 6 months;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Garvan Institute of Medical Research

Darlinghurst, New South Wales, 2010, Australia

Location

Retina Associates - South West Retina

Liverpool, New South Wales, 2170, Australia

Location

Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2032, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Cairns Hospital

Cairns, Queensland, 4870, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Southern Adelaide Diabetes and Endocrine Services

Oaklands Park, South Australia, 5046, Australia

Location

University Hospital Geelong

Geelong, Victoria, 3220, Australia

Location

Heidelberg Repatriation Hospital

Heidelberg, Victoria, 3081, Australia

Location

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Auckland Diabetes Centre

Auckland, 1051, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Belfast Health and Social Care Trust

Belfast, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic RetinopathyDiabetic NephropathiesDiabetes MellitusRetinal Diseases

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • Anthony Keech, Professor

    NHMRC Clinical Trials Centre, The University of Sydney

    PRINCIPAL INVESTIGATOR

  • Alicia Jenkins, Professor

    NHMRC Clinical Trials Centre, The University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 22, 2011

Study Start

November 3, 2016

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

GB(1)AU(20)HK(1)NZ(2)