薬理と治療

Abstract

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 combination with an α-glucosidase inhibitor（α-GI）in Japanese patients with type 2 diabetes mellitus who have inadequate glycemic control with an α-GI alone. 113 patients were administered ipragliflozin 50 mg╱day additionally, and then 57 patients were continued with 50 mg and 42 patients were increased to 100 mg after 20 weeks. The changes from baseline（mean±SD）in HbA1c, fasting plasma glucose（FPG）and body weight indicated significant reduction of －0.82±0.712％（P＜0.001）, －35.7±29.95 mg╱dL（P＜0.001）and －2.78±2.321 kg（P＜0.001）at Week 52（LOCF：Last Observation Carried Forward）, respectively. Ipragliflozin exerted a glycemic control effect from 2 weeks after administration and lasted until the end of treatment. After increased to 100 mg at Week 20, mean changes in FPG and HbA1c levels were further decreased, and the percentage of patients with an HbA1c level＜7.0％ increased. The overall incidence of adverse events（AEs）and drug-related AEs were 77.0％ and 33.6％, respectively and the majority of them were mild or moderate in severity. The most common AEs were nasopharyngitis （40.7％）, pollakiuria （8.8％）, thirst（7.1％）, back pain（6.2％）and constipation （5.3％）. These results indicate that ipragliflozin is effective for patients with type 2 diabetes mellitus who have inadequate glycemic control with an α-GI alone and its safety is also confirmed.