Empagliflozin Monotherapy in Japanese Patients with Type 2 Diabetes Mellitus: a Randomized, 12-Week, Double-Blind, Placebo-Controlled, Phase II Trial
Empagliflozin Monotherapy in Japanese Patients with Type 2 Diabetes Mellitus: a Randomized, 12-Week, Double-Blind, Placebo-Controlled, Phase II Trial
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DOI：
10.1007/s12325-014-0126-8
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发表时间：
2014-06-01
影响因子：
3.8
通讯作者：
Broedl, Uli C.
中科院分区：
文献类型：
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作者：
Kadowaki, Takashi;Haneda, Masakazu;Broedl, Uli C.
本研究旨在探讨日本2型糖尿病(T2 DM)患者单用依帕利嗪治疗的有效性和耐受性。糖化血红蛋白(HbA1c)为千分之7.0-万分之10%的患者通过交互式网络响应系统被随机分为5、10、25、50 mg或安慰剂每日1次进行双盲治疗，共12周。主要终点是第12周时HbA1c的变化。其他终点包括HbA1c患者的百分比和第12周时空腹血糖(FPG)、体重和收缩压(SBP)与基线的变化。共有547名患者被随机分为5 mg(n=110)、10 mg(n=109)、25 mg(n=109)、50 mg(n=110)或安慰剂(n=109)治疗12周。与安慰剂相比，调整后的HbA1c变化的平均[95%可信区间]差异：5毫克依帕利嗪为-0.72%(-0.87，-0.57)，10毫克为-0.70%(-0.85，-0.55)，25毫克为-0.95%(-1.10，-0.80)，50毫克为-0.91(-1.06，-0.76)(均为P<；0.001)。在基线时，糖化血红蛋白为千分之7.0%的患者中，服用依帕格列酮的患者达到7.0%的比例(19-33%)多于服用安慰剂的患者(3%)。与安慰剂相比，empagliflzin降低了空腹血糖、体重(两个终点的所有剂量均为0.001)和SBP(分别为10、25和50毫克，分别为p=0.001、p=0.014和p=0.003)。接受安慰剂治疗的患者中有42%的患者报告了不良事件，而接受依帕格列酮治疗的患者中有33%-38%的患者报告了不良事件。在任何治疗组中，几乎没有证实的低血糖不良事件或与尿路感染或生殖器感染相一致的事件。在日本的T2 DM患者中，恩帕利氟秦单药治疗12周，可降低HbA1c、空腹血糖、体重和SBP，且耐受性良好。
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) a parts per thousand yen7.0-a parts per thousand currency sign10% 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 a parts per thousand yen7.0% 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.