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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01320345




Registration number
NCT01320345
Ethics application status
Date submitted
18/03/2011
Date registered
22/03/2011
Date last updated
5/06/2024

Titles & IDs
Public title
The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
Scientific title
A Randomised Trial to Evaluate the Efficacy on Retinopathy and Safety of Fenofibrate in Adults With Type 1 Diabetes. A Multicentre Double-blind Placebo-controlled Study in Australia and Internationally.
Secondary ID [1] 0 0
ACTRN12611000249954
Secondary ID [2] 0 0
FAME0001
Universal Trial Number (UTN)
Trial acronym
FAME 1 EYE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 0 0
Diabetic Retinopathy 0 0
Diabetic Nephropathies 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fenofibrate
Treatment: Drugs - Inert lactose placebo

Experimental: Fenofibrate - 145 mg tablet of fenofibrate administered daily for 36 months.

Placebo comparator: Placebo - Inert lactose tablet (otherwise matching active) administered daily for 36 months.


Treatment: Drugs: Fenofibrate
145 mg tablet of fenofibrate administered once daily for 36 months.

Treatment: Drugs: Inert lactose placebo
Insert lactose tablet matching active tablet administered once daily for 36 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of clinical significant retinopathy progression.
Timepoint [1] 0 0
As reported throughout the study and/or annual eye assessment post-randomisation
Secondary outcome [1] 0 0
The individual components of the primary endpoint
Timepoint [1] 0 0
At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Secondary outcome [2] 0 0
Occurrence of clinically significant macula oedema (CSME).
Timepoint [2] 0 0
As reported throughout the study
Secondary outcome [3] 0 0
Need for laser surgery for DR
Timepoint [3] 0 0
As reported throughout the study
Secondary outcome [4] 0 0
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy
Timepoint [4] 0 0
As reported throughout the study
Secondary outcome [5] 0 0
Visual acuity.
Timepoint [5] 0 0
At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Secondary outcome [6] 0 0
Macular volume and thickness
Timepoint [6] 0 0
At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Secondary outcome [7] 0 0
Albuminuria.
Timepoint [7] 0 0
At baseline, 12 m post-randomisation, 24 m post-randomisation, the end of study visit (which is on average 36 months post-randomisation) and wash-out visit.
Secondary outcome [8] 0 0
Estimated glomerular filtration rate.
Timepoint [8] 0 0
At study completion and washout visit
Secondary outcome [9] 0 0
Peripheral neuropathy status
Timepoint [9] 0 0
At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Secondary outcome [10] 0 0
Autonomic neuropathy.
Timepoint [10] 0 0
At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Secondary outcome [11] 0 0
Total cardiovascular events.
Timepoint [11] 0 0
As reported throughout the study.
Secondary outcome [12] 0 0
Frequency of foot ulcer and non-traumatic amputation.
Timepoint [12] 0 0
As reported throughout the study

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Garvan Institute of Medical Research - Darlinghurst
Recruitment hospital [5] 0 0
Retina Associates - South West Retina - Liverpool
Recruitment hospital [6] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [7] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [8] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [9] 0 0
Cairns Hospital - Cairns
Recruitment hospital [10] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [11] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
Southern Adelaide Diabetes and Endocrine Services - Oaklands Park
Recruitment hospital [14] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [15] 0 0
Heidelberg Repatriation Hospital - Heidelberg
Recruitment hospital [16] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment hospital [17] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [18] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [19] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [20] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
2291 - Merewether
Recruitment postcode(s) [7] 0 0
2032 - Randwick
Recruitment postcode(s) [8] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [9] 0 0
4870 - Cairns
Recruitment postcode(s) [10] 0 0
4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3081 - Heidelberg
Recruitment postcode(s) [16] 0 0
3004 - Melbourne
Recruitment postcode(s) [17] 0 0
3065 - Melbourne
Recruitment postcode(s) [18] 0 0
3050 - Parkville
Recruitment postcode(s) [19] 0 0
3021 - St Albans
Recruitment postcode(s) [20] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
New Territories
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Belfast

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Juvenile Diabetes Research Foundation Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Mylan Pharmaceuticals Inc
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01320345
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Keech, Professor
Address 0 0
NHMRC Clinical Trials Centre, The University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Liping Li
Address 0 0
Country 0 0
Phone 0 0
+61 2 9562 5000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01320345