2019至2021年度中国糖尿病药物临床试验的开展状况  

Advances in clinical trials of diabetes drugs research in China,2019 to 2021

作　　者：苗苗[1] 王情情 周雁[2] 王晓霞 房虹 赵海娟[1] 刘飞 黄慧瑶 王伟好 李宁 郭慧玲 王欣[1] 郭立新[2] Miao Miao;Wang Qingqing;Zhou Yan;Wang Xiaoxia;Fang Hong;Zhao Haijuan;Liu Fei;Huang Huiyao;Wang Weihao;Li Ning;Guo Huiling;Wang Xin;Guo Lixin(Clinical Trials Research Center,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Endocrinology,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Clinical Trails Center,National Cancer Center,National Clinical Research Center for Cancer,Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Department of Respiratory and Critical Care Medicine,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100043,China)

机构地区：[1]北京医院临床试验研究中心国家老年医学中心中国医学科学院老年医学研究院,北京100730 [2]北京医院内分泌科国家老年医学中心中国医学科学院老年医学研究院,北京100730 [3]国家癌症中心国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京100021 [4]首都医科大学附属北京朝阳医院呼吸与危重症医学科,北京100043

出　　处：《中华糖尿病杂志》2022年第6期563-569,共7页CHINESE JOURNAL OF DIABETES MELLITUS

基　　金：中国医学科学院医学与健康科技创新工程临床试验能力提升(GCP)平台建设项目(2020-I2M-2-007);北京医院院级课题(BJ-2019-173)。

摘　　要：目的了解2019至2021年度中国糖尿病药物临床试验的开展情况。方法基于药物临床试验登记和信息公示平台(http://www.chinadrugtrials.org.cn/)登记的药物临床试验信息,以及国家药品监督管理局药品审评中心-信息公开-受理品种目录中登记的药物注册信息。根据首次公示信息日期,选取2019年1月1日至2021年12月31日在该平台登记注册的药物临床试验,以“糖尿病”检索适应证为糖尿病相关的临床试验,收集试验基本信息、试验管理信息、试验设计信息等,对申办方类型、试验分期、试验范围、试验药物类型等进行分析。结果2019至2021年药物临床试验登记和信息公示平台共登记8002项药物临床试验,其中糖尿病相关药物临床试验589项,占同期全部药物临床试验的比例为7.36%。从试验范围看,567项(96.26%)为国内试验,22项(3.74%)为国际多中心试验。其中,542项(92.02%)由国内制药企业发起,47项(7.98%)由国外制药企业发起;生物等效性试验最多,为299项(50.76%),Ⅰ期试验174项(29.54%),Ⅱ期+Ⅲ期试验共112项(19.00%)。在试验药物申请类型中,以新药最多,为201项(34.13%),仿制药157项(26.66%),进口药36项(6.11%);按照药物分类划分,化学药物占比最高为456项(77.42%),生物制品125项(21.22%),中药/天然药物8项(1.36%)。根据药物作用统计,试验药物作用主要集中在二肽基肽酶Ⅳ抑制剂共105项(17.83%)、胰高糖素样肽-1受体激动剂共65项(11.04%)、钠-葡萄糖共转运蛋白2抑制剂共64项(10.87%),胰岛素及胰岛素类似物共53项(9.00%)、复合制剂共49项(8.32%)、二甲双胍共48项(8.15%)等。结论2019至2021年度我国糖尿病药物临床试验开展数量多,新药研发创新性已有很大提升,一些跨国企业积极将新药早期研究引进中国。Objective To explore the latest development of clinical trials of diabetes drugs in China from 2019 to 2021.Methods Information based on the platforms for drug clinical trial registration and information and accepted variety catalog registration information of Center for Drug Evaluation(http://www.chinadrugtrials.org.cn/).Extracting the information of clinical trials of diabetes drugs during 2019 to 2021,including basic information,management information,the scope and stage of the trial,type of the sponsor and drugs.Chi-square was used to compare the counting data between domestic and foreign pharmaceutical enterprises.Results Five hundred and eighty nine clinical trials of diabetes drugs registered in China during 2019 to 2021,accounted for 7.36%(589/8002)of all varieties.From the scope of trials,domestic trials accounted for 96.26%(567/589),international multi-center trials taked up 3.74%(22/589).From the type of sponsors,domestic pharmaceutical companies initiated 542(92.02%)and among which,global pharmaceutical companies initiated 47(7.98%).Analyze by the phase of the trials,the bioequivalence test was 50.76%(299/589),the phaseⅠclinical trial was 29.54%(174/589),and the phase 2 and 3 trials were 19.00%(112/589).From the perspective of the type of the drugs,innovative drugs were the most common type of drugs(34.13%,201/589),generic drugs accounted for 26.66%(157/589)and imported medicine occupied 6.11%(36/589).According to registration classification were divided into chemical drugs(77.42%,456/589),biological products(21.22%,125/589)and traditional chinese medicine/natural medicine(1.36%,8/589).The main focus in terms of the type of drug being tested was dipeptidyl peptidaseⅣinhibitor(105/589,17.83%),glucagon-like peptide-1 receptor agonist(65/589,11.04%),sodium-glucose cotransporter 2 inhibitor(64/589,10.87%),insulin and insulin analogues(53/589,9.00%),compound preparations(49/589,8.32%)and metformin(48/589,8.15%).Conclusions There are a large number of diabetes clinical drug trials in my country from 201

关 键 词：糖尿病 降糖药物 临床试验 中国 

分 类 号：R587.1[医药卫生—内分泌]