Efficacy and Safety of Tofogliflozin on 24-H Glucose Profile Based on Continuous Glucose Monitoring: Crossover Study of Sodium-Glucose Cotransporter 2 Inhibitor.

Background: To compare the impact of two sodium-glucose cotransporter 2 (SGLT2) inhibitors, tofogliflozin and ipragliflozin, on hypoglycemia in patients with type 2 diabetes mellitus (T2DM), treated with sulfonylureas. Methods: Thirty patients with T2DM were allocated to treatment with either 20 mg/day tofogliflozin or 50 mg/day ipragliflozin and underwent continuous glucose monitoring (CGM) for 5 days at three times in a crossover manner. Results: The percent time spent at glucose <70 mg/dL per 24 h was 0.48, 2.77, and 0.06%, before treatment with SGLT2 inhibitors and treatment with ipragliflozin and tofogliflozin, respectively (P = 0.1135, difference between SGLT2 inhibitors). The addition of either ipragliflozin or tofogliflozin to sulfonylureas markedly and significantly improved other CGM-derived parameters, including average plasma glucose, standard deviation of glucose, mean postprandial glucose excursion, percent time with glucose >140, >180 mg/dL, and >200 mg/dL, area over the curve <70, area under the curve >140, >180, and >200, and maximum and minimum plasma glucose. However, there were no significant differences in these parameters between the two SGLT2 inhibitors. Conclusions: Based on the CGM, the addition of tofogliflozin to sulfonylureas tended to decrease the percent time spent in hypoglycemia in T2DM patients. The addition of SGLT2 inhibitors to sulfonylureas improved the average glucose level and reduced glucose fluctuations without increasing the time in hypoglycemia.