Fenofibrate for Type 1 Diabetes
(PERL-FENO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether fenofibrate, a drug typically used to lower blood fats, can protect kidneys in people with type 1 diabetes who are at high risk of kidney failure. Researchers aim to determine if fenofibrate can prevent or slow kidney damage in those with early-to-moderate diabetic kidney disease. Participants will receive either fenofibrate or a placebo (an inactive pill) and will have their kidney function checked at the start and end of the study. Individuals who have had type 1 diabetes for 8 or more years and are experiencing worsening kidney function might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that fenofibrate is likely to be safe for humans?
Research has shown that fenofibrate is generally safe for people with diabetes. In studies involving patients with type 2 diabetes, fenofibrate lowered blood fats without raising major safety concerns. Participants did not experience a significant increase in serious side effects compared to those not taking the drug. Common side effects were mild, such as upset stomach and muscle pain.
The FDA has already approved fenofibrate for lowering cholesterol and triglycerides, indicating its well-established safety. However, this trial examines its potential to protect the kidneys in people with type 1 diabetes, presenting a different context. Nonetheless, existing research on fenofibrate provides a strong basis for considering it safe for many individuals.12345Why do researchers think this study treatment might be promising for diabetes?
Researchers are excited about fenofibrate for type 1 diabetes because it offers a novel approach compared to standard insulin treatments. Fenofibrate is typically used to lower cholesterol, but it appears to have a unique effect on inflammation and blood vessel health, which could benefit those with type 1 diabetes by potentially reducing complications. This alternative mechanism of action distinguishes it from traditional therapies that primarily focus on blood sugar control, offering a fresh angle in diabetes management.
What evidence suggests that fenofibrate might be an effective treatment for diabetic kidney disease?
Research has shown that fenofibrate, a drug typically used to lower blood fats, might protect the kidneys from diabetes-related damage. In individuals with type 2 diabetes, fenofibrate has been linked to fewer heart issues and deaths. Two studies suggested that fenofibrate could also help prevent kidney damage in people with diabetes. However, most evidence comes from individuals with type 2 diabetes, not type 1. This trial will test fenofibrate to determine if it can provide similar kidney protection for those with type 1 diabetes. Participants in this trial will receive either fenofibrate or a placebo to evaluate its effectiveness.25678
Who Is on the Research Team?
Alessandro Doria, MD PhD MPH
Principal Investigator
Joslin Diabetes Center
Michael Mauer, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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