Gao Yan, Yoon Kun Ho, Chuang Lee-Ming, Mohan Viswanathan, Ning Guang, Shah Sanjiv, Jang Hak Chul, Wu Ta-Jen, Johns Don, Northrup Justin, Brodows Robert
Department of Endocrinology, Peking University First Hospital, Beijing, China.
Diabetes Res Clin Pract. 2009 Jan;83(1):69-76. doi: 10.1016/j.diabres.2008.09.037. Epub 2008 Nov 18.
To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.
Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA(1c) change.
466 patients (age 54+/-9 years, weight 68.7+/-11.2 kg, BMI 26.3+/-3.3 kg/m(2), and HbA(1c) 8.3+/-1.1%; mean+/-S.D.) were enrolled in the full analysis set. Endpoint HbA(1c) reduction (mean [95% CI]) with exenatide was superior to placebo (-1.2 [-1.3, -1.1]% vs. -0.4 [-0.5, -0.2]%, p<0.001). More exenatide- than placebo-treated patients achieved HbA(1c) <or=7% (48% vs. 17%, p<0.001). At endpoint, weight reduction was greater with exenatide (-1.2 [-1.5, -0.9]kg) than placebo (-0.1 [-0.3, 0.2]kg), p<0.001. Nausea, generally mild-to-moderate, was the most common adverse event with exenatide (25% vs. 1% with placebo). The incidence of symptomatic hypoglycaemia with exenatide and placebo were 36% and 9%, respectively (p<0.001). Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively.
Exenatide treatment improved glycaemic control in Asian patients with T2D and had a similar safety profile as in non-Asian patients.
评估艾塞那肽对口服降糖药治疗控制不佳的亚洲2型糖尿病（T2D）患者的疗效。
将单独服用二甲双胍（MET）或联合磺脲类药物（SU）的患者随机分为两组，分别接受艾塞那肽5微克，随后10微克，每日两次，共治疗4周和12周，或接受安慰剂治疗。主要终点为从基线到终点的糖化血红蛋白（HbA1c）变化。
466例患者（年龄54±9岁，体重68.7±11.2千克，体重指数26.3±3.3千克/平方米，糖化血红蛋白8.3±1.1%；均值±标准差）纳入全分析集。艾塞那肽组终点糖化血红蛋白降低幅度（均值[95%可信区间]）优于安慰剂组（-1.2[-1.3，-1.1]%对-0.4[-0.5，-0.2]%，p<0.001）。达到糖化血红蛋白≤7%的艾塞那肽治疗患者多于安慰剂治疗患者（48%对17%，p<0.001）。在终点时，艾塞那肽组体重减轻幅度（-1.2[-1.5，-0.9]千克）大于安慰剂组（-0.1[-0.3，0.2]千克），p<0.001。恶心是艾塞那肽最常见的不良事件，一般为轻至中度（25%对安慰剂组的1%）。艾塞那肽组和安慰剂组有症状低血糖的发生率分别为36%和9%（p<0.001）。服用艾塞那肽联合MET或MET及SU的患者低血糖发生率（事件/患者年）分别为1.8（0.9，3.7）和4.7（3.5，6.5）。
艾塞那肽治疗可改善亚洲T2D患者的血糖控制，且安全性与非亚洲患者相似。
