单用二甲双胍或二甲双胍加磺脲类药物血糖控制不佳的2型糖尿病患者加用艾塞那肽的

疗效和安全性的临床研究

　　高妍 宁光 贾伟平 李光伟 刘志民 田浩明 刘超 马建华 郭晓蕙 郑以漫 骆天红

　　【摘要】 目的 评估用二甲双胍和磺脲类控制不佳的2型糖尿病加用艾塞那肽治疗的疗效和安全性。 方法 单用二甲双胍或二甲双胍加磺脲类药物血糖控制不佳(HbA1c≥7.0% 及 ≤11.0%)的2型糖尿病患者，在原先治疗的基础上，随机分组至治疗组和对照组，其中治疗组先用艾塞那肽5μg每天两次治疗4周，再用10μg每天两次治疗12周，观察终点时HbA1c的变化。结果 试验结束时艾塞那肽组患者HbA1c下降幅度显著高于安慰剂组(分别为-1.2%和-0.3%，差值为-0.8%， P<0.001)，HbA1c≤7%的患者的百分比艾塞那肽组显著高于安慰剂组(分别为46%和14%，P<0.001)，早餐及晚后的血糖波动(餐后减去餐前血糖的差值)的改善艾塞那肽组也显著优于安慰剂组(P<0.001)。体重下降幅度艾塞那肽组显著大于安慰剂组(两组间LS均数差为-1.2kg，P<0.001)。 结论 艾塞那肽可改善中国人2型糖尿病患者的血糖控制。

　　【关键词】艾塞那肽;糖尿病，2型;胰高糖素样肽1

　　Efficacy and safety of exenatide in Chinese patients type 2 diabetes inadequately controlled with metformin or metformin and a sulfonylurea

　　GAO Yan, NING Guang, JIA Wei- Ping et al, *Endocrinology Department, Peking University First Hospital, Beijing 100034, China

　　【Abstract】 Objective To evaluate the efficacy of exenatide in Chinese patients with type 2 diabetes (T2D) inadequately controlled with metformin and/or a sulfonylurea. Methods Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 ug then 10 ug twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA1c change. Results Endpoint HbA1c reduction (mean [95% CI]) with exenatide was superior to placebo (-1.2 % vs. -0.3%, difference -0.8%, p < 0.001). More exenatide- than placebo-treated patients achieved HbA1c ≤7% (46% vs. 14%, p < 0.001). Exenatide reduced postprandianl glucose excursions (pre- minus postmeal levels) compared with placebo after breakfast and dinner (p<0.001). At end point, weight reduction was greater with exenatide than placebo (LS mean difference was -1.2, p <0.001). Conclusion Exenatide treatment improved glycaemic control in Chinese patients with T2D and had a similar safety profile as in non-Asian patients.

　　【Key words】 Exenatide; Diabetes Mellitus, type 2; glucagon-like peptide 1 (GLP-1)