司美格鲁肽片单药对比安慰剂治疗生活方式干预不佳中国2型糖尿病患者的有效性及安全性:PIONEER-11研究亚组分析  

Efficacy and safety of oral semaglutide monotherapy compared with placebo in Chinese patients with type 2 diabetes who had insufficient glycemic control with diet and exercise alone:A subset analysis of the PIONEER-11 Trial

作　　者：王卫庆[1] 李玉凤[2] 叶新华 董碧璇 申泽薇 Wang Weiqing;Li Yufeng;Ye Xinhua;Dong Bixuan;Shen Zewei(Department of Endocrine and Metabolic Diseases,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Department of Endocrinology,Bejing Pinggu Hospital,Bejing 101200,China;Department of Endocrinology and Metabolism,Afiliated Changzhou the Second People's Hospital of Nanjing Medical University,Changzhou 213164,China;Medical Quality,Novo Nordisk(Shanghai)Pharmaceutical Trading Co.,Ltd.,Beijing 100102,China)

机构地区：[1]上海交通大学医学院附属瑞金医院内分泌代谢病科,上海200025 [2]北京市平谷区医院内分泌科,北京101200 [3]南京医科大学附属常州第二人民医院内分泌代谢科,常州213164 [4]诺和诺德(上海)医药贸易有限公司医药质量部,北京100102

出　　处：《中华内分泌代谢杂志》2024年第11期932-940,共9页Chinese Journal of Endocrinology and Metabolism

摘　　要：目的评估不同剂量司美格鲁肽片治疗仅通过饮食和运动血糖控制不佳的中国2型糖尿病(type 2 diabetes mellitus, T2DM)患者的有效性和安全性。方法 PIONEER-11研究是一项随机、双盲、多国多中心研究。预设中国亚组人群占总例数的3/4, 随机分配到司美格鲁肽片3、7、14 mg和安慰剂组。主要终点为治疗26周时糖化血红蛋白(glycated hemoglobin A_(1C), HbA_(1C))相对基线的变化。本研究是按照预先计划分析中国人群亚组的有效性和安全性。结果本研究共纳入390例中国T2DM患者, 基线时平均年龄约为51岁, T2DM病程1.8年, HbA_(1C) 7.9%, 体重指数为26.5 kg/m^(2)。经过26周治疗, 司美格鲁肽片3、7、14 mg组和安慰剂组的HbA_(1C)相对基线的变化分别为-1.1%、-1.6%、-1.6%和0.0%, 体重相对基线的变化分别为-0.7、-1.9、-2.6和-0.7 kg。各组与安慰剂组的HbA_(1C)估计治疗差异(estimated treatment difference, ETD)分别为-1.2%(95%CI -1.4~-0.9)、-1.7%(95%CI -1.9~-1.4)和-1.6%(95%CI -1.9~-1.4), 差异均有统计学意义(均P<0.001)。7 mg和14 mg组的体重降幅显著大于安慰剂组[7 mg ETD, -1.2 kg(95%CI -2.1~-0.4), P=0.006;14 mg ETD, -1.9 kg(95%CI -2.8~-1.0), P<0.001]。最常见的胃肠道不良事件为腹泻(司美格鲁肽片3.1%~12.5%对安慰剂2.0%)和恶心(3.1%~6.3%对2.0%), 绝大多数为轻度, 且呈一过性。结论对于仅接受饮食和运动血糖控制不佳的中国T2DM患者, 所有剂量司美格鲁肽片均能有效改善血糖, 且7 mg和14 mg剂量能有效降低体重, 安全性特征与全球研究人群一致。Objective To investigate the efficacy and safety of oral semaglutide in Chinese patients with type 2 diabetes mellitus(T2DM)inadequately controlled by diet and exercise only.Methods In the randomized,doubleblind,multicenter,multinational PIONEER-1l trial,Chinese patients were prospectively randomly assigned to receive oral semaglutide 3,7,or 14 mg,or placebo.The primary endpoint was the change from baseline in glycated hemoglobin(HbA_(1C))at week 26.This is a pre-defined subset analysis to assess the efficacy and safety in Chinese patients.Results Totally 390 Chinese T2DM patients were enrolled(mean age 51 years),with a T2DM duration of 1.8 years,HbA_(1C) of 7.9%,and BMI of 26.5 kg/m^(2)at baseline.Overall,changes at week 26 from baseline in HbA_(1C) were-1.1%,-1.6%,-1.6%,and 0.0%,and in bodyweight were-0.7,-1.9,-2.6,and-0.7 kg in oral semaglutide(3,7,or 14 mg)and placebo groups,respectively.Compared to the placebo group,estimated treatment differences(ETDs)in HbA_(1C) for the 3,7,and 14 mg groups were-1.2%(95%CI-1.4,-0.9),-1.7%(95%CI-1.9,-1.4),and-1.6%(95%CI-1.9,-1.4)(all P<0.001),respectively,and in weight loss for the 7 mg and 14 mg groups were-1.2 kg(95%CI-2.1,-0.4;P=0.006)and-1.9 kg(95%CI-2.8,-1.0;P<0.001),respectively.The most frequent gastrointestinal adverse events were diarrhea(oral semaglutide:3.1%-12.5%vs placebo:2.0%)and nausea(3.1%-6.3%us 2.0%),mostly mild in severity and transient.Conclusion In Chinese patients with T2DM who had insufficient glycemic control with diet and exercise only,oral semaglutide showed better glycemic control at doses of 3,7,and 14 mg and more weight loss at doses of 7 and 14 mg compared to placebo,with a safety profile consistent with that observed in the global trial population.

关 键 词：糖尿病 2型 司美格鲁肽片 有效性 安全性 中国 

分 类 号：R587.1[医药卫生—内分泌]