Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study

Prior treatment

• Receiving therapy with all three of the study medication prior to enrolment.
• Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment
• Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone)
• Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone)
• Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
• Kidney transplant or dialysis

Other illness

• Heart failure NYHA class IV at screening
• Known or suspected hypersensitivity to the study medications or related products
• History of pancreatitis at the screening visit
• Type 1 diabetes
• Addison's Disease
• Autosomal dominant or autosomal recessive polycystic kidney disease
• Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening.
• Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.

Lab values

• Moderately - or severely increased albuminuria with a UACR ≥ 200 mg/g or CKD with an eGFR \< 30 ml/min/1.73m2 at the screening visit.
• Serum potassium \> 5.0 mmol/L at the screening visit
• Treatment with a potassium-sparing diuretic (amiloride, triamterene)
• Elevated Alanine Aminotransferase (ALT) \> 3x upper normal limit, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of oesophageal varices or a history of portocaval shunt.)

Other

• A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.
• Body mass index \< 18.5 kg/m2 at the screening visit
• Known or suspected abuse of narcotics.
• Participant in another intervention study,
• Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent)

• Men and women over 18 years of age.
• Type 2 diabetes with no clinical signs of HF NYHA Class IV
• Able to understand the written participant information and give informed consent.