Efficacy of luseogliflozin for renal function preservation in patients with type 2 diabetes mellitus and impaired renal function: A randomized open‐label clinical trial ( RESOLUTION study)

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ABSTRACT Introduction The renoprotective effects of luseogliflozin, a sodium‐glucose cotransporter 2 inhibitor, in patients with renal dysfunction are unexamined. We evaluated the efficacy of luseogliflozin in slowing renal function decline among patients with type 2 diabetes mellitus and moderate to severe renal dysfunction. Materials and Methods In a multicenter, randomized, open‐label, controlled clinical trial, patients with type 2 diabetes mellitus and an estimated glomerular filtration rate based on serum creatinine (eGFRcreat) of 15–45 mL/min/1.73 m 2 were randomized into luseogliflozin or control groups. The primary endpoint was the change in eGFRcreat from baseline to 104 weeks. Secondary endpoints included eGFRcreat and eGFRcreat slope changes from 4 to 104 weeks (chronic eGFRcreat slope). Results Among 152 participants, eGFRcreat change from baseline to 104 weeks did not significantly differ between groups. The luseogliflozin group showed a significant decrease in eGFRcreat from 2 to 12 weeks compared to the control group; the largest decline occurred at 4 weeks (initial eGFR decline). There were no differences between groups thereafter. The chronic eGFRcreat slope was less negative in the luseogliflozin group compared to the control group (not significant). Conversely, subgroup analysis indicated that the difference in chronic eGFRcreat slope between groups was significantly greater (with a less negative or even positive slope observed in the luseogliflozin group compared to the control group) among patients with eGFRcreat <30 mL/min/1.73 m 2 , urinary albumin/creatinine ratio <30 mg/g creatinine, systolic blood pressure <130 mmHg, or females. Conclusions Although the primary endpoint did not reach statistical significance, l useogliflozin may provide renoprotective benefits in patients with type 2 diabetes mellitus and moderate‐to‐severe renal impairment, potentially by slowing eGFRcreat decline post‐initial decline.

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