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

Locations

2
Steno Diabetes Center Northern Denmark9260, Gistrup Denmark
Steno Diabetes Center Copenhagen2730, Herlev Denmark

Sponsors and collaborators

Peter Rossing

Lead sponsor

Steno Diabetes Center Copenhagen

Sponsor institution

Steno Diabetes Center Nordjylland

Collaborator

Aarhus University Hospital

Collaborator