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. 2014 Jun;31(6):621-38. doi: 10.1007/s12325-014-0126-8. Epub 2014 Jun 24.
This study was designed to determine the efficacy and tolerability of empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus (T2DM).
Patients with glycosylated hemoglobin (HbA1c) ≥ 7.0 - ≤ 10% were randomized via an interactive web response system, and treated double-blind with empagliflozin 5, 10, 25, 50 mg, or placebo once daily for 12 weeks. The primary endpoint was change from baseline in HbA1c at week 12. Other endpoints included percentage of patients with HbA1c <7.0% and changes from baseline in fasting plasma glucose (FPG), body weight, and systolic blood pressure (SBP) at week 12.
A total of 547 patients were randomized and treated with empagliflozin 5 mg (n = 110), 10 mg (n = 109), 25 mg (n = 109), 50 mg (n = 110), or placebo (n = 109) for 12 weeks. Adjusted mean [95% confidence interval (CI)] differences vs. placebo in changes from baseline in HbA1c were -0.72% (-0.87, -0.57) with empagliflozin 5 mg, -0.70% (-0.85, -0.55) with 10 mg, -0.95% (-1.10, -0.80) with 25 mg, and -0.91 (-1.06, -0.76) with 50 mg (all p < 0.001). More patients with HbA1c ≥ 7.0% at baseline reached HbA1c <7.0% with empagliflozin (19-33%) than placebo (3%). Compared with placebo, empagliflozin reduced FPG, body weight (p < 0.001 for all doses for both endpoints) and SBP (p = 0.001, p = 0.014 and p = 0.003 for empagliflozin 10, 25, and 50 mg, respectively). Adverse events were reported by 42% of patients receiving placebo and 33-38% of patients receiving empagliflozin. There were few reports of confirmed hypoglycemic adverse events or events consistent with urinary tract infection or genital infection in any treatment group.
Empagliflozin monotherapy for 12 weeks in Japanese patients with T2DM reduced HbA1c, FPG, body weight and SBP, and was well tolerated.
本研究旨在确定恩格列净单药治疗对日本2型糖尿病（T2DM）患者的疗效和耐受性。
糖化血红蛋白（HbA1c）≥7.0%至≤10%的患者通过交互式网络应答系统进行随机分组，并接受双盲治疗，分别给予恩格列净5毫克、10毫克、25毫克、50毫克或安慰剂，每日一次，共12周。主要终点是第12周时HbA1c相对于基线的变化。其他终点包括HbA1c<7.0%的患者百分比以及第12周时空腹血糖（FPG）、体重和收缩压（SBP）相对于基线的变化。
共有547例患者被随机分组，接受恩格列净5毫克（n = 110）、10毫克（n = 109）、25毫克（n = 109）、50毫克（n = 110）或安慰剂（n = 109）治疗12周。与安慰剂相比，恩格列净各剂量组HbA1c相对于基线变化的调整后均值[95%置信区间（CI）]差异为：5毫克组-0.72%（-0.87，-0.57），10毫克组-0.70%（-0.85，-0.55），25毫克组-0.95%（-1.10，-0.80），50毫克组-0.91%（-1.06，-0.76）（均p < 0.001）。与安慰剂组（3%）相比，基线时HbA1c≥7.0%的患者使用恩格列净后达到HbA1c<7.0%的比例更高（19%-33%）。与安慰剂相比，恩格列净降低了FPG、体重（两个终点的所有剂量p均<0.001）和SBP（恩格列净10毫克、25毫克和50毫克组的p值分别为0.001、0.014和0.003）。接受安慰剂治疗的患者中有42%报告了不良事件，接受恩格列净治疗的患者中有33%-38%报告了不良事件。在任何治疗组中，确诊的低血糖不良事件或与尿路感染或生殖器感染相关的事件报告较少。
恩格列净单药治疗日本T2DM患者12周可降低HbA1c、FPG、体重和SBP，且耐受性良好。
