Ipragliflozin is a selective sodium/glucose cotransporter 2（SGLT2）inhibitor and shows insulin-independent glycemic control effect by enhancing urinary glucose excretion. We examined the efficacy and safety of ipragliflozin 50 mg（increased dose 100 mg）once daily for 52 weeks in Japanese patients with type 2 diabetes mellitus. To assess effects of food intake on efficiency of the drug, 182 patients were randomized to receive ipragliflozin 50 mg before or after breakfast. At Week 20, 70 patients increased to 100 mg and 98 patients continued on 50 mg.
　　At week 20 and 52, the change from baseline showed significant reduction in HbA1c（％）, fasting plasma glucose and body weight were −0.53±0.67％（P＜0.001）and −0.51±0.81％ （P＜0.001）, −32.8±30.3 mg/dL（P＜0.001）and −32.7±31.7 mg/dL（P＜0.001）, −2.79 ±1.68 kg（P＜0.001）and −3.41±2.30 kg（P＜0.001）, respectively. The proportion of patients reaching HbA1c levels＜7.0％ increased to 30.4％ both Week 20 and Week 52.
　　Treatment-emergent adverse events（TEAEs）were observed in 90.1％ of patients. The majority of AEs were mild or moderate in severity. Incidence of hypoglycemia, genital tract infection, and urinary tract infection, AE of special interests, were 1.6％, 2.2％, and 6.0％, respectively.
　　Ipragliflozin given for 52 weeks was well tolerated and showed a sustained efficacy with a safety profile as expected in T2DM patients in both groups. Administration of ipragliflozin before or after breakfast resulted in comparable efficacy and safety.