Kadowaki Takashi, Haneda Masakazu, Inagaki Nobuya, Terauchi Yasuo, Taniguchi Atsushi, Koiwai Kazuki, Rattunde Henning, Woerle Hans J, Broedl Uli C
Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan.
Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.
The aim of this randomized, double-blind, parallel-group study was to investigate the safety and efficacy of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes (T2DM).
In a 12-week dose-finding period, patients [N = 547; mean baseline glycosylated hemoglobin (HbA1c) 7.92-8.02%] received empagliflozin (5, 10, 25, or 50 mg) or placebo. In a 40-week extension period, patients on empagliflozin 10 or 25 mg continued the same treatment and patients on other doses were reallocated to empagliflozin 10 or 25 mg. Outcomes at week 52 included changes from baseline in HbA1c, fasting plasma glucose (FPG), weight and blood pressure (BP) in patients who received empagliflozin 10 or 25 mg in both the initial 12 weeks and the extension and safety in patients treated with ≥1 dose of empagliflozin 10 or 25 mg.
Adjusted mean ± SE changes in HbA1c from baseline at week 52 were -0.67 ± 0.09% and -0.86 ± 0.09%, in FPG were -24.7 ± 3.2 mg/dL and -31.3 ± 3.4 mg/dL, and in body weight were -3.1 ± 0.4 kg and -3.1 ± 0.4 kg, with empagliflozin 10 and 25 mg, respectively. Both doses reduced systolic and diastolic BP. Adverse events were reported in 70.8% and 66.8% of patients on empagliflozin 10 and 25 mg, respectively. Confirmed hypoglycemic adverse events (plasma glucose ≤70 mg/dL and/or requiring assistance) were reported in one patient per group.
Empagliflozin monotherapy for 52 weeks led to sustained reductions in HbA1c, FPG, weight and BP and was well tolerated in Japanese patients with T2DM.
Boehringer Ingelheim and Eli Lilly and Company.
这项随机、双盲、平行组研究的目的是调查恩格列净单药治疗52周对日本2型糖尿病（T2DM）患者的安全性和有效性。
在为期12周的剂量探索期，患者[N = 547；平均基线糖化血红蛋白（HbA1c）7.92 - 8.02%]接受恩格列净（5、10、25或50毫克）或安慰剂治疗。在为期40周的延长期，接受10或25毫克恩格列净治疗的患者继续相同治疗，其他剂量组的患者重新分配至10或25毫克恩格列净组。第52周的结果包括在最初12周和延长期均接受10或25毫克恩格列净治疗的患者的HbA1c、空腹血糖（FPG）、体重和血压（BP）相对于基线的变化，以及接受≥1剂量10或25毫克恩格列净治疗患者的安全性。
恩格列净10毫克组和25毫克组在第52周时HbA1c相对于基线的调整后均值±标准误变化分别为 -0.67 ± 0.09%和 -0.86 ± 0.09%，FPG分别为 -24.7 ± 3.2毫克/分升和 -31.3 ± 3.4毫克/分升，体重分别为 -3.1 ± 0.4千克和 -3.1 ± 0.4千克。两个剂量组均降低了收缩压和舒张压。接受10毫克和25毫克恩格列净治疗的患者中分别有70.8%和66.8%报告了不良事件。每组均有1例患者报告了确诊的低血糖不良事件（血糖≤70毫克/分升和/或需要协助）。
恩格列净单药治疗52周可使HbA1c、FPG、体重和血压持续降低，且日本T2DM患者对其耐受性良好。
勃林格殷格翰公司和礼来公司。
