Advances in clinical trials of diabetes drugs research in China, 2019 to 2021
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
Abstract
ObjectiveTo explore the latest development of clinical trials of diabetes drugs in China from 2019 to 2021.
MethodsInformation 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.
ResultsFive hundred and eighty nine clinical trials of diabetes drugs registered in China during 2019 to 2021, accounted for 7.36% (589/8 002) 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 phase Ⅰ clinical 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 peptidase Ⅳ inhibitor (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%).
ConclusionsThere are a large number of diabetes clinical drug trials in my country from 2019 to 2021, and the innovation of new drug research and development has been greatly improved. Some multinational companies are introducing early research on new drugs into China actively.
Key words:
Diabetes mellitus; Hypoglycemic agent; Clinical trials; China
Contributor Information
Miao Miao
Clinical Trials Research Center,Beijing Hospital,National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Wang Qingqing
Clinical Trials Research Center,Beijing Hospital,National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Zhou Yan
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Wang Xiaoxia
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Fang Hong
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
Zhao Haijuan
Clinical Trials Research Center,Beijing Hospital,National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Liu Fei
Clinical Trials Research Center,Beijing Hospital,National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Huang Huiyao
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
Wang Weihao
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Li Ning
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
Guo Huiling
Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, China
Wang Xin
Clinical Trials Research Center,Beijing Hospital,National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Guo Lixin
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
