Treatment and follow-up
T2D, cardio ankle
TYPE 2 DIABETES, BLIND
All participants will visit their regular physicians for usual health care, individualized background medications, administration of study drug, and monitoring of safety, and drug adherence during the study. In principle, baseline tests should be conducted within 60 days after obtaining consent, and treatment with study drug should begin thereafter. To assess the study endpoints, post-randomization follow-up visits are scheduled at 4 and 12 weeks before the final visit at 24 weeks (Fig. Study design. CAVI, cardio ankle vascular index; eGFR, estimated glomerular filtration rate; T2D, type 2 diabetes; UACR, urinary albumin-to-creatinine ratio. 1 If the date of discontinuation is within the allowance of each visit, observation and examination will be performed to the extent possible. 2 In principle, baseline testing should be conducted within 60 days of obtaining consent, and study drug dosing should begin thereafter. 3 Height, weight, office and home blood pressure (optional), and office and home pulse rate (optional). Data after obtaining consent will be prioritized. However, data within 3 months prior to obtaining consent can be used. Height will be measured at baseline only. 4 Serum creatinine and eGFR alone. 5 Serum pentosidine, urinary type IV collagen, urinary α1-microglobulin, β2-microglobulin, urinary neutrophil gelatinase-associated lipocalin, N-acetyl-β-d-glucosaminidase, and urinary liver-type fatty acid-binding protein corrected by urinary creatinine. 6 Hemoglobin, hematocrit, serum albumin and potassium, HbA1c, plasma (or serum) aldosterone concentration, and plasma (or serum) renin activity (or concentration). 7 Serum potassium alone. 8 Serum potassium and HbA1c alone. 9 Serum potassium, HbA1c, plasma (or serum) aldosterone concentration, and plasma (or serum) renin activity (or concentration) aloneAll randomized participants will be instructed to take either dose-adjusted finerenone or placebo orally once daily (preferably at the same time each day in the morning). Participants with a baseline eGFR < 60 mL/min/1.73 mDiscontinuance criteria11. If the blind code is opened12. If the investigator finds that it is appropriate to discontinue participation in the trial due to certain reasons