Efficacy and safety of saxagliptin in drug-naive Asian patients with type 2 diabetes mellitus: a randomized controlled trial
Efficacy and safety of saxagliptin in drug-naive Asian patients with type 2 diabetes mellitus: a randomized controlled trial
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DOI：
10.1002/dmrr.1306
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发表时间：
2012-03-01
影响因子：
8
通讯作者：
Zhao, June
中科院分区：
文献类型：
--
作者：
Pan, Chang Yu;Yang, Wenying;Zhao, June
很少有研究评估新型口服降糖药在亚洲人群中的应用。本研究评估了沙格列汀与安慰剂相比在亚洲2型糖尿病（T2 DM）患者中的疗效和安全性。材料和方法将568例未经药物治疗的T2 DM和糖化血红蛋白水平（HbA（1c））为7.0-10.0%（53-86 mmol/mol）的成人患者以1：1的比例随机分配至沙格列汀5 mg/d或安慰剂组。疗效终点包括HbA（1c）、空腹血糖（FPG）、0 - 180 min餐后血糖曲线下面积（PPG AUC（0-180））从基线至第24周的变化，沙格列汀组和安慰剂组中达到HbA（1c）≥ 1起AE（不包括低血糖）的患者比例分别为43.3%和35.6%。两个治疗组中均很少有患者发生SAE（沙格列汀组2.8%;安慰剂组1.4%）。低比例的患者报告低血糖事件（1.8%，沙格列汀; 0.7%，安慰剂）。结论沙格列汀改善血糖控制，并在药物初治的亚洲T2 DM患者中耐受良好。版权所有（C）2011约翰威利父子有限公司
Background Few studies have assessed the use of new oral anti-diabetic agents in Asian populations. This study assesses the efficacy and safety of saxagliptin versus placebo in Asian patients with type 2 diabetes mellitus (T2DM).Materials and Methods Five hundred sixty-eight drug-naive adult patients with T2DM and glycated haemoglobin levels (HbA(1c)) of 7.0-10.0% (53-86 mmol/mol) were randomized 1 : 1 to receive saxagliptin 5 mg daily or placebo. Efficacy endpoints included changes from baseline to week 24 in HbA(1c), fasting plasma glucose (FPG), post-prandial glucose area under the curve from 0 to 180 min (PPG AUC(0-180)), and the proportion of patients achieving HbA(1c) = 1 AE (excluding hypoglycaemia) was 43.3% for saxagliptin and 35.6% for placebo. Few patients in either treatment group experienced an SAE (2.8%, saxagliptin; 1.4%, placebo). A low proportion of patients reported hypoglycaemic events (1.8%, saxagliptin; 0.7%, placebo).Conclusions Saxagliptin improved glycaemic control and was well tolerated in drug-naive Asian patients with T2DM. Copyright (C) 2011 John Wiley & Sons, Ltd.