Fenofibrate for Type 1 Diabetes
(PERL-FENO Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking fibrates or other similar drugs. You should discuss your specific medications with the trial team to be sure.
What evidence supports the effectiveness of the drug fenofibrate for type 1 diabetes?
Is fenofibrate safe for use in humans?
Fenofibrate has been used safely in humans for conditions like high cholesterol and triglycerides, with studies showing it is generally well tolerated. In trials, it has been used alone or in combination with other drugs without serious adverse effects, and it has shown potential benefits for cardiovascular and microvascular health.26789
How does the drug fenofibrate differ from other treatments for type 1 diabetes?
What is the purpose of this trial?
Diabetic kidney disease remains the leading cause of end-stage kidney disease (ESKD), rising in frequency in parallel with the epidemic of diabetes worldwide. The estimated lifetime risk of kidney disease in persons with type 1 diabetes (T1D) has been reported to be as high as 50-70%, although risk may be lower in excellent care environments. Two previous studies have suggested that a generic drug used to lower fats in blood (fenofibrate) may protect the kidney from damage due to diabetes. These data, however, were obtained among people with type 2 diabetes with clinical characteristics optimized for cardiovascular studies. Thus, a clinical trial specifically designed to evaluate the effects on the kidney is required to firmly show that this drug can prevent kidney damage in T1D. The goals of the present pilot study are to demonstrate the feasibility of such trial, gather essential information for designing and planning this study, and generate preliminary data. To this end, 40 participants with T1D and early-to-moderate diabetic kidney disease (DKD), at high risk of ESKD, will be enrolled at two clinical sites and assigned in a 1:1 ratio to treatment with fenofibrate or placebo for 18 months. Kidney function will be measured at the beginning and at the end of the study to evaluate the effect of fenofibrate.
Research Team
Alessandro Doria, MD PhD MPH
Principal Investigator
Joslin Diabetes Center
Michael Mauer, MD
Principal Investigator
University of Minnesota
Eligibility Criteria
Adults aged 18-70 with Type 1 Diabetes and early-to-moderate kidney disease at high risk of progressing to end-stage kidney disease. Participants must have been treated with insulin within a year of diagnosis, have specific levels of kidney function, and be willing to follow the study plan. Exclusions include other health conditions like non-diabetic kidney diseases, allergies to fibrates or iodine, recent blood donations, pregnancy without contraception use, drug abuse history, certain medical histories including pancreatitis and cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either fenofibrate or placebo for 18 months
Washout
Participants undergo a two-month washout period to assess the effects of discontinuing the treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fenofibrate
Fenofibrate is already approved in United States, European Union, Canada for the following indications:
- High cholesterol
- Severe high triglycerides
- Mixed hyperlipidemia
- Primary hypercholesterolemia
- Severe hypertriglyceridemia
- Hyperlipidemia
- Hypertriglyceridemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alessandro Doria
Lead Sponsor
University of Minnesota
Collaborator
University of Michigan
Collaborator