Discussion
hypoxia, DKD, renal dysfunction
HYPOXIA, TYPE 2 DIABETES, RECRUITMENT
Several large-scale randomized control studies have provided evidence of the cardioprotective and renoprotective effects of SGLT2i [The possible renal protective effects of SGLT2i are diverse, including lowering blood pressure via natriuresis and osmotic diuresis, reducing hypoxia in the proximal tubule via tubular workload reduction, and anti-inflammation-fibrosis action [The target number of patients is 110 (1:1 = canagliflozin group: control group). This protocol was approved by the Certified Review Board of the Nagoya University Graduate School of Medicine on November 6, 2020 (Version 1.2), and opened to the public on the website of the Japan Registry of Clinical Trials on November 27, 2020. We enrolled the first patient on December 23, 2020. By the end of June 2022, we enrolled 81 patients from three participating hospitals and further recruitment is ongoing. This study is expected to end in 2025. The FAGOTTO study is the first randomized controlled study of canagliflozin to assess renal hemodynamics in patients with type 2 diabetes and moderate renal dysfunction. Although further studies will be needed, the data from this study will provide evidence for optimal therapy to prevent progression of DKD.