We assessed the effects of a 12-week ipragliflozin treatment on the liver-to-spleen attenuation ratio (L/ S ratio) using computed tomography and on alanine transaminase (ALT) levels in Japanese patients with type 2 diabetes mellitus (T2DM). Sixty-two patients with T2DM [age, 56 ± 8 years; hemoglobin A1c (HbA1c) levels, 8.1 ± 0.9%; body mass index (BMI), 27.5 ± 3.3 kg/m 2 ] were randomly assigned in a 2:1 ratio to receive ipragliflozin (50 mg/day; ipragliflozin group; n = 40) or continued treatment (control group; n = 22) for 12 weeks. The primary endpoints were changes in ALT levels; the secondary endpoints included changes in the L/S ratio and in the visceral fat area (VFA) and subcutaneous fat area (SFA) before and after 12 weeks of the treatment as assessed by computed tomography. ALT levels (-12.45 vs. ?5.82 IU/l, P \ 0.001), L/S ratio (?0.07 vs. -0.08, P \ 0.001), SFA (-5.8 vs. ?13.3 cm 2 , P \ 0.05), and VFA (?1.4 vs. ?20.4 cm 2 , P \ 0.05) significantly changed from baseline in the ipragliflozin group compared with the values in the control group. Multiple regression analysis among all subjects revealed that the independent factor contributing to the %DALT and %DL/C ratio was treatment group alone (ipragliflozin group = 1; control group = 0; b coefficient = -32.08, P \ 0.001 and b coefficient = 19.98, P \ 0.05, respectively). Thus, ipragliflozin may lower ALT levels associated with increased L/S ratios, indicating its potential therapeutic efficacy in T2DM-associated hepatic steatosis.

Abstract.We report a 54-year