Comparison of Ipragliflozin and Pioglitazone Effects on Nonalcoholic Fatty Liver Disease in Patients With Type 2 Diabetes: A Randomized, 24-Week, Open-Label, Active-Controlled Trial

OBJECTIVE To compare the efficacy of ipragliflozin versus pioglitazone in patients with type 2 diabetes complicated by nonalcoholic fatty liver disease (NAFLD). RESEARCH DESIGN AND METHODS In this open-label, randomized, active-controlled trial, we randomly assigned 66 patients with type 2 diabetes and NAFLD to receive ipragliflozin 50 mg (n = 32) or pioglitazone 15-30 mg (n = 34) orally once daily. The primary outcome was a change from-baseline in the liver-to-spleen attenuation ratio (L/S ratio) on computed tomography at week 24. RESULTS At week 24, the mean 6 SD L/S ratio had increased by 0.22 (from 0.80 +/- 0.24 to 1.00 +/- 0.18) in the ipragliflozin group and 0.21 (from 0.78 +/- 0.26 to 0.98 +/- 0.16) in the pioglitazone group (P = 0.90). Serum aspartate and alanine aminotransferase levels, HbA(1c), and fasting plasma glucose were similarly reduced in the two treatment groups. Nevertheless, body weight and visceral fat area showed significant reductions only in the ipragliflozin group compared with the pioglitazone group (P < 0.0001 and P = 0.0013, respectively). There were no serious adverse events in either group. CONCLUSIONS Compared with pioglitazone, ipragliflozin exerts equally beneficial effects on NAFLD and glycmic control during the treatment of patients with type 2 diabetes complicated by NAFLD. Furthermore, ipragliflozin significantly reduced body weight and abdominal fat area.