Patients with type 2 diabetes mellitus complicated by diabetic nephropathy
Conditions
Interventions
Finerenone
Sponsors
TAKAMURA TOSHINARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients diagnosed with type 2 diabetes mellitus with diabetic nephropathy within 12 weeks 2 Serum potassium of 5.0 or lower 3 Patients receiving treatment with an ACEI or an ARB 4 Age of 20 years or older at the time of obtaining informed consent 5 Type 2 diabetes mellitus managed for at least 4 weeks before screening 6 Patients who can provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1 History of hypersensitivity to finerenone or contraindications to finerenone 2 Use of an MRA within 4 weeks before screening 3 Changes in medications within 4 weeks before screening 4 Use of strong CYP3A4 inhibitors 5 History of severe hypersensitivity to MIBG or iodine 6 Type 1 diabetes mellitus or gestational diabetes mellitus 7 Diabetic ketoacidosis, hyperosmolar hyperglycemic state, or poorly controlled and unstable diabetes 8 Absolute indication for insulin therapy 9 History of severe hypoglycemic episodes 10 Poor blood pressure control 11 Severe diabetic retinopathy requiring urgent treatment 12 Currently receiving treatment for malignant disease 13 Pregnant or breastfeeding women 14 Patients deemed by the investigator to be unable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle sympathetic nerve activity (MSNA) burst frequency (BF, bursts per minute) at 24 weeks after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Burst incidence and total MSNA from treatment initiation to 24 weeks 2 Changes in MSNABI and MSNABF from baseline to 24 weeks 3Iodine123 MIBG of the heart, kidneys, and liver indices, including washout rate, heart to mediastinum ratio, kidney to background ratio, and liver to background ratio 4 BF, BI, and total MSNA from treatment initiation to 12 weeks 5 Organ specific insulin sensitivity and endogenous insulin secretory capacity assessed by a hyperinsulinemic euglycemic clamp combined with stable isotope labeled glucose 6 Autonomic nervous system activity assessed by heart rate variability, time-domain analysis, and frequency domain analysis 7 Assessment of baroreflex sensitivityby analysis of MSNA, blood pressure, and electrocardiography, including sympathetic baroreflex sensitivity and cardiac vagal baroreflex sensitivity 8 Skin sympathetic nerve activity assessed using ECG patch electrodes 9 Heart rate and blood pressure 10 Body composition 11 Renal function 12 Echocardiographic assessment of left ventricular ejection fraction, left ventricular diastolic function, and cardiac workload 13 Blood and urine tests Blood tests, Adrenal hormone tests, and Urine tests 14 Basal metabolic rate, respiratory quotient, and oxidative and non-oxidative glucose metabolism assessed by indirect calorimetry 15 Association between organ-specific sympathetic nerve activity and organspecific insulin sensitivity 16 Association between patient background characteristics and evaluation parameters 17 Peripheral blood gene expression related to glucose and lipid metabolism 18 Safety outcomes serious adverse events and adverse events leading to discontinuation of the study drug | — |
Contacts
Public ContactYUMIE TAKESHITA
Kanazawa University Hospital
Outcome results
None listed