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
Sponsors and collaborators
Peter Rossing
Lead sponsor
Steno Diabetes Center Copenhagen
Sponsor institution
Steno Diabetes Center Nordjylland
Collaborator
Aarhus University Hospital
Collaborator