40 Participants Needed

Fenofibrate for Type 1 Diabetes

(PERL-FENO Trial)

Recruiting at 3 trial locations
CM
Overseen ByChristine Mendonca
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alessandro Doria
Must be taking: Insulin, RASB
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

A case study showed that a 19-year-old with newly diagnosed type 1 diabetes became insulin-independent after starting fenofibrate, suggesting it might help manage blood sugar levels in type 1 diabetes.12345

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?

Fenofibrate is unique for type 1 diabetes because it may help some patients reduce or eliminate their need for insulin by improving the body's natural ability to control blood sugar. This is different from standard treatments that typically focus on insulin replacement.12456

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

AD

Alessandro Doria, MD PhD MPH

Principal Investigator

Joslin Diabetes Center

MM

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

I have diabetic kidney disease at high risk of worsening.
You have had type 1 diabetes for at least 8 years.
My kidney function, measured by eGFR, is between 40 and 99.9.
See 5 more

Exclusion Criteria

I have had gallstones but my gallbladder has been removed.
Your hemoglobin (a protein in red blood cells) level is too low (less than 11 g/dL for males, less than 10 g/dL for females) or your platelet count is too low (less than 100,000/mm3) at the time of screening.
My kidney disease is not caused by diabetes.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either fenofibrate or placebo for 18 months

76 weeks

Washout

Participants undergo a two-month washout period to assess the effects of discontinuing the treatment

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Fenofibrate
Trial Overview The trial is testing whether fenofibrate can prevent further damage in kidneys affected by diabetes in people with Type 1 Diabetes. Forty participants will either receive fenofibrate or a placebo for 18 months at two clinical sites. The main goal is to see if there's an improvement in their kidney function compared to those who just get the placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FenofibrateExperimental Treatment1 Intervention
145 mg oral fenofibrate daily for 76 weeks. Dosage is decreased to 48 mg daily if iGFR is or is estimated to be below 30 ml/min/1.73 m2.
Group II: PlaceboPlacebo Group1 Intervention
Inactive tablets identical to fenofibrate

Fenofibrate is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Fenofibrate for:
  • High cholesterol
  • Severe high triglycerides
🇪🇺
Approved in European Union as Fenofibrate for:
  • Mixed hyperlipidemia
  • Primary hypercholesterolemia
  • Severe hypertriglyceridemia
🇨🇦
Approved in Canada as Fenofibrate for:
  • Hyperlipidemia
  • Hypertriglyceridemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alessandro Doria

Lead Sponsor

Trials
3
Recruited
720+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Findings from Research

Type 2 diabetic patients on statins who had high triglycerides and low HDL cholesterol saw a 31% reduction in cardiovascular events when fenofibrate was added to their treatment.
This means that for every 20 patients treated with fenofibrate over five years, one cardiovascular event could be prevented, highlighting its efficacy in this specific patient group.
ACCORD LIPID study results strengthen guideline approach of adding fenofibrate to therapy of dyslipidaemic type 2 diabetic patients.Aalbers, J.[2013]
In a study of 31 type 2 diabetic patients, fenofibrate treatment significantly improved glycemic control by lowering fasting and postprandial blood glucose levels, as well as reducing fasting serum insulin and leptin levels over 3 months.
Fenofibrate also effectively reduced triglyceride levels and increased HDL cholesterol, demonstrating its benefits for both lipid profiles and insulin resistance, while being well tolerated by all participants.
Fenofibrate treatment is associated with better glycemic control and lower serum leptin and insulin levels in type 2 diabetic patients with hypertriglyceridemia.Damci, T., Tatliagac, S., Osar, Z., et al.[2022]

References

ACCORD LIPID study results strengthen guideline approach of adding fenofibrate to therapy of dyslipidaemic type 2 diabetic patients. [2013]
Insulin Independence in Newly Diagnosed Type 1 Diabetes Patient following Fenofibrate Treatment. [2020]
3.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Expediency of the use of fibrates for primary and secondary prevention of cardiovascular complications.]. [2018]
Fenofibrate treatment is associated with better glycemic control and lower serum leptin and insulin levels in type 2 diabetic patients with hypertriglyceridemia. [2022]
Long-term fenofibrate therapy increases fibroblast growth factor 21 and retinol-binding protein 4 in subjects with type 2 diabetes. [2013]
Summarizing the FIELD study: lessons from a 'negative' trial. [2013]
Fibrates after the FIELD study: Some answers, more questions. [2015]
Combination therapy with metformin and fenofibrate for insulin resistance in obesity. [2017]
Saroglitazar is noninferior to fenofibrate in reducing triglyceride levels in hypertriglyceridemic patients in a randomized clinical trial. [2022]
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