摘要
目的评估用二甲双胍和磺脲类控制不佳的T2DM患者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T2DM患者,在原治疗的基础上,随机分为治疗组和对照组,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<0.01),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<0.01),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<0.01)。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<0.01)。结论艾塞那肽可改善我国T2DM患者的血糖控制情况。
Objective To evaluate the efficacy of exenatide in Chinese patients with type 2 diabetes （T2DM） inadequately controlled with metformin and safety or metformin plus 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 versus endpoint HbA1 c change. Results Endpoint HbA1 c reduction （mean [ 95 % CI]） with exenatide was superior to placebo （ -- 1.2 % vs -- 0. 3 %, difference - 0.8 %, P〈 0. 01）. More exenatide-than placebo-treated patients achieved HbA1c ≤7% （46% vs 14% P〈0. 01）. Exenatide reduced postprandianl glucose excursions （pre- minus postmeal levels） compared with placebo after breakfast and dinner （P〈0. 01）. At end point, weight reduction was greater with exenatide than placebo （LS mean difference was - 1.2, P〈0. 01）. Conclusion Exenatide treatment improveds glycaemic control in Chinese patients with T2DM and hasd a similar safety profile as in non-Asian patients.
出处
《中国糖尿病杂志》
CAS
CSCD
北大核心
2012年第11期857-861,共5页
Chinese Journal of Diabetes
关键词
艾塞那肽
糖尿病
2型
胰升糖素样肽-1
Exenatide
Diabetes Mellitus, type 2
glucagon-like peptide 1 （GLP-1）
