Nishimura R, Osonoi T, Kanada S, Jinnouchi H, Sugio K, Omiya H, Ubukata M, Sakai S, Samukawa Y
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Naka Kinen Clinic, Ibaraki, Japan.
Diabetes Obes Metab. 2015 Aug;17(8):800-4. doi: 10.1111/dom.12481. Epub 2015 Jun 4.
The aim of the present study was to determine the effects of luseogliflozin on 24-h glucose levels, assessed by continuous glucose monitoring, and on pharmacodynamic variables measured throughout the day. In this double-blind, placebo-controlled, crossover study, 37 patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized into two groups. Patients in each group first received luseogliflozin then placebo for 7 days each, or vice versa. After 7 days of treatment, the mean 24-h glucose level was significantly lower with luseogliflozin than with placebo [mean (95% confidence interval) 145.9 (134.4-157.5) mg/dl vs 168.5 (156.9-180.0) mg/dl; p < 0.001]. The proportion of time spent with glucose levels ≥70 to ≤180 mg/dl was significantly greater with luseogliflozin than with placebo [median (interquartile range) 83.2 (67.7-96.5)% vs 71.9 (46.9-83.3)%; p < 0.001] without inducing hypoglycaemia. The decrease in glucose levels was accompanied by reductions in serum insulin levels throughout the day.
本研究的目的是确定鲁索格列净对通过持续葡萄糖监测评估的24小时血糖水平以及全天测量的药效学变量的影响。在这项双盲、安慰剂对照、交叉研究中，37例饮食和运动控制不佳的2型糖尿病患者被随机分为两组。每组患者先接受鲁索格列净治疗7天，然后接受安慰剂治疗7天，或反之。治疗7天后，鲁索格列净治疗组的平均24小时血糖水平显著低于安慰剂组[均值（95%置信区间）145.9（134.4 - 157.5）mg/dl对168.5（156.9 - 180.0）mg/dl；p < 0.001]。血糖水平≥70至≤180 mg/dl的时间比例，鲁索格列净组显著高于安慰剂组[中位数（四分位间距）83.2（67.7 - 96.5）%对71.9（46.9 - 83.3）%；p < 0.001]，且未诱发低血糖。血糖水平下降的同时，全天血清胰岛素水平也降低。
