Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorPeter Rossing

About this trial

Diabetic neuropathy is a serious and common complication of diabetes that currently has no cure. One form of this condition is cardiovascular autonomic neuropathy (CAN), which affects about 20% of people with diabetes-an estimated 100 million people worldwide. CAN is a significant risk factor for death and health problems like heart disease and kidney damage, and may contribute to the high rates of cardiovascular-related deaths in people with diabetes.

This study is a double-blind, randomized, placebo-controlled, two-center trial. The study aims to test whether finerenone can treat cardiovascular autonomic neuropathy in patients with type 2 diabetes. The trial will evaluate the effects of 78 weeks of treatment with finerenone or a placebo, assigned randomly in a 1:1 ratio, on early-stage cardiovascular autonomic neuropathy. The trial will include 100 participants with type 2 diabetes. Additionally, the study will investigate how the treatment impacts other types of neuropathy and related pathological mechanisms.

Eligibility criteria

Qualifiers

Given informed consent

Type 2 diabetes defined by WHO criteria

Aged 40 ≥ at inclusion

Pathological E/I ratio (Mean value of three measures)

Disqualifiers

No CAN (no abnormal CARTs)

Definite CAN (more than one abnormal CART)

HbA1C >100 mmol/L

Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible.

Trial design

Treatments tested in this trial

  • Kerendia (Finerenone, BAY94-8862)
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Peter Rossing

Lead sponsor

Steno Diabetes Center Copenhagen

Sponsor institution

Steno Diabetes Center Nordjylland

Collaborator

Aarhus University Hospital

Collaborator