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

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