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.

Who is this study for? Adult patients with type 1 diabetes
What treatments are being studied? Fenofibrate
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Cairns Hospital
RECRUITING
Cairns
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Concord Repatriation General Hospital
RECRUITING
Concord
Garvan Institute of Medical Research
RECRUITING
Darlinghurst
Fremantle Hospital
RECRUITING
Fremantle
Canberra Hospital
RECRUITING
Garran
University Hospital Geelong
RECRUITING
Geelong
Heidelberg Repatriation Hospital
RECRUITING
Heidelberg
Retina Associates - South West Retina
RECRUITING
Liverpool
Baker Heart and Diabetes Institute
RECRUITING
Melbourne
St Vincent's Hospital Melbourne
RECRUITING
Melbourne
Hunter Diabetes Centre
RECRUITING
Merewether
Southern Adelaide Diabetes and Endocrine Services
RECRUITING
Oaklands Park
The Royal Melbourne Hospital
RECRUITING
Parkville
Prince of Wales Hospital
RECRUITING
Randwick
Royal North Shore Hospital
RECRUITING
Saint Leonards
Mater Adult Hospital
RECRUITING
South Brisbane
Sunshine Hospital
RECRUITING
St Albans
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Shatin
New Zealand
Auckland Diabetes Centre
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
United Kingdom
Belfast Health and Social Care Trust
RECRUITING
Belfast
Contact Information
Primary
Liping Li
fame1eye.study@sydney.edu.au
+61 2 9562 5000
Time Frame
Start Date: 2016-11-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 450
Treatments
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.
Sponsors
Collaborators: Mylan Pharmaceuticals Inc, National Health and Medical Research Council, Australia, Juvenile Diabetes Research Foundation Australia
Leads: University of Sydney

This content was sourced from clinicaltrials.gov