Min Kyung Wan, Ku Bon Jeong, Lee Ji Hyun, Kim Min Seon, Ahn Kyu Jeung, Lee Moon Kyu, Kokubo Satoshi, Yoshida Satoshi, Cho Hyun Ji, Cha Bong Soo
Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.
Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea.
Diabetes Metab J. 2017 Apr;41(2):135-145. doi: 10.4093/dmj.2017.41.2.135.
This is a subgroup analysis of Korean patients from a phase 3 clinical trial investigating the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin.
This multicenter, placebo-controlled, double-blind, parallel-group study was carried out between November 2011 and January 2013. Patients entered a 2-week placebo pretreatment period, followed by a 24-week treatment period with either ipragliflozin (50 mg/day) or placebo, while continuing metformin. Efficacy outcomes (glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], and body weight) and safety outcomes (treatment-emergent adverse events [TEAEs]) were measured and compared between the two treatment groups for patients enrolled in all 18 study sites in Korea.
Eighty-two Korean patients received ipragliflozin (n=43) or placebo (n=39) during the study period. Mean changes in HbA1c levels from baseline to the end of treatment were -0.97% in the ipragliflozin group and -0.31% in the placebo group, with an adjusted between-group difference of -0.60% (P<0.001). Compared to placebo, FPG and body weight also decreased significantly (both P<0.001) from baseline after treatment in the ipragliflozin group, with between-group differences of -21.4 mg/dL and -1.53 kg, respectively. Decreased weight was the most common TEAE in the ipragliflozin group (7.0%); there were no reports of genital and urinary tract infection.
Ipragliflozin treatment in addition to metformin led to significant improvement in glycemic outcomes and reduction in body weight in Korean patients with type 2 diabetes mellitus, compared with metformin treatment alone; the safety profile was comparable in both groups.
这是一项对来自一项3期临床试验的韩国患者的亚组分析，该试验旨在研究依帕列净对二甲双胍控制不佳的2型糖尿病患者的疗效和安全性。
这项多中心、安慰剂对照、双盲、平行组研究于2011年11月至2013年1月进行。患者进入为期2周的安慰剂预处理期，随后接受为期24周的依帕列净（50毫克/天）或安慰剂治疗，同时继续服用二甲双胍。对韩国所有18个研究地点入组的患者，在两个治疗组之间测量并比较疗效指标（糖化血红蛋白[HbA1c]、空腹血糖[FPG]和体重）和安全性指标（治疗中出现的不良事件[TEAE]）。
在研究期间，82名韩国患者接受了依帕列净（n = 43）或安慰剂（n = 39）治疗。依帕列净组从基线到治疗结束时HbA1c水平的平均变化为-0.97%，安慰剂组为-0.31%，调整后的组间差异为-0.60%（P < 0.001）。与安慰剂相比，依帕列净组治疗后FPG和体重也较基线显著下降（均P < 0.001），组间差异分别为-21.4毫克/分升和-1.53千克。体重减轻是依帕列净组最常见的TEAE（7.0%）；未报告生殖器和尿路感染。
与单独使用二甲双胍治疗相比，在二甲双胍基础上加用依帕列净治疗可使韩国2型糖尿病患者的血糖指标显著改善，体重减轻；两组的安全性相当。
