<span style="font-family:&quot;font-size:medium;">基于临床试验登记平台的糖尿病</span><span style="font-family:&quot;font-size:medium;">治疗药物研发现状分析</span>

冯俊逸, 李烨, 张炳畅, 石慧, 杨珏

doi:magtech-2025-09-02-00001

中国药物评价 >

2025 , Vol. 42 >Issue 6: 492 - 492-496

DOI: https://doi.org/magtech-2025-09-02-00001

管理研究

基于临床试验登记平台的糖尿病治疗药物研发现状分析

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无锡市惠山区人民医院药物临床试验办公室，江苏无锡 214187

冯俊逸，女，主管药师，研究方向：医院药学

收稿日期: 2025-09-02

修回日期: 2025-10-01

录用日期: 2026-01-07

网络出版日期: 2026-01-07

基金资助

无锡市惠山区人民医院2024年医院“战略人才”项目（24FY-002）

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Analysis of the Clinical Trial Research for Diabetes Drugs Based on the China Drug Trials Platform

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Clinical Trial Institution Office， Wuxi Huishan District People′s Hospital， Jiangsu Wuxi 214187， China

Received date: 2025-09-02

Revised date: 2025-10-01

Accepted date: 2026-01-07

Online published: 2026-01-07

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摘要

目的：分析2019—2024年糖尿病及其并发症治疗药物的研发情况和临床试验趋势特点，为我国糖尿病及其并发症治疗药物的研发提供建议与参考。方法：从备案年份、试验分期、试验药物适应证及试验药物的来源、作用机制等角度出发，全方位对我国糖尿病及其并发症治疗药物临床试验的现状进行分析。结果：平台上筛选糖尿病及其并发症的药物临床试验共1449项，数量大体呈现逐年增加的趋势，生物等效性试验占比过半，研发适应证以2型糖尿病为主，且生物与化学来源的试验药物数量各占约50%。在Ⅰ~Ⅳ期降糖药物临床试验中，研究数量最多的是GLP-1受体激动剂。结论：我国糖尿病治疗药物临床试验数量稳步增长，仿制药研发活跃，创新药研发聚焦GLP-1类药物。未来糖尿病治疗药物临床试验设计应更多关注多靶点和个体化策略，以期获得糖尿病患者的综合代谢获益。

关键词： ; font-size:medium; "> ; 药物临床试验；糖尿病；生物等效性试验；Ⅰ~Ⅳ期临床试验

本文引用格式

冯俊逸, 李烨, 张炳畅, 石慧, 杨珏 . 基于临床试验登记平台的糖尿病治疗药物研发现状分析[J]. 中国药物评价, 2025 , 42(6) : 492 -492-496 . DOI: magtech-2025-09-02-00001

Abstract

Objective： To understand the trends and characteristics of clinical trials on diabetes drugs and its complications in the past six years， and to provide a reference basis for the development and clinical research in China. Methods： From the perspectives of registration years， trial phases， indications of trial drugs， and sources and mechanisms of action of trial drugs， a comprehensive analysis was conducted on the current status of clinical trials for diabetes and its complication treatments in China. Results： A total of 1449 clinical trials were selected， showing an overall increasing trend year by year. More than half of these are bioequivalence trials， with the primary indication for drug development being type 2 diabetes. Additionally， the number of trial drugs derived from biological and chemical sources accounts for approximately 50% each. In phase Ⅰ to Ⅳ clinical trials of diabetes drugs， the top drugs were GLP-1 receptor agonists. Conclusion： The number of clinical trials of diabetes drugs in China has steadily increased， the research and development of generic drugs has been active， and the research and development of innovative drugs has focused on GLP-1 drugs. In the future， the clinical trial design of diabetes drugs should pay more attention to multi target and individualized strategies， in order to obtain the comprehensive metabolic benefits of diabetes patients.

Key words： ; font-size:medium; ">Drug clinical trials； Diabetes； Bioequivalent test； Phase Ⅰ-Ⅳ clinical trials

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