Long Jianyan, Liang Ruiming, Zheng Qiuyi, Yuan Gang, Xin Ziyi, Chen Xinwen, Lai Fenghua, Liu Yihao
Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, People's Republic of China.
Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, People's Republic of China.
Diabetes Metab Syndr Obes. 2021 Jan 26;14:367-377. doi: 10.2147/DMSO.S288065. eCollection 2021.
A better understanding of the current features of type 2 diabetes mellitus (T2DM)-related clinical trials is important for improving designs of clinical trials and identifying neglected areas of research. It was hypothesized that the trial registration policy promoted the designs of T2DM-related trials over the years. Therefore, this study aimed to present a comprehensive overview of T2DM-related clinical trials registered in the ClinicalTrials.gov database.
T2DM-related clinical trials registered in the ClinicalTrials.gov database were searched and assessed the characteristics of the relevant trials. We searched PubMed and Google Scholar for the publication statuses of the primary completed trials.
Overall, 5117 T2DM-related trials were identified for analysis. Of the interventional trials, 71.5% had a primary treatment purpose while only 8.9% were prevention or health service. There were more interventional trials registered prior to patient recruitment between 2012 and 2019 than between 2004 and 2011 (44.6% vs 19.9%, <0.001). The period between 2012 and 2019 also had more trials that enrolled <100 participants (59.2% vs 50.9%), were single-center studies (60.7% vs 50.6%), had non-randomized allocations (11.3% vs 6.3%), were open-label (49.2% vs 45.6%), and had smaller sample sizes than the period between 2004 and 2011 (all <0.001). The five-year cumulative publication rates after primary completion of the trials were <40%.
Although the ClinicalTrials.gov database did not include all clinical trials, the trials registered in the ClinicalTrials.gov database still accounted for most of the clinical studies. Encouragingly, more interventional trials were registered prior to patient recruitment over the years. The majority of T2DM-related clinical trials focused on drug-related treatment, and trials regarding prevention in T2DM should be promoted. More attention should be paid to improve the publication and dissemination of clinical trials results.
更好地了解2型糖尿病（T2DM）相关临床试验的当前特征，对于改进临床试验设计和识别被忽视的研究领域至关重要。据推测，多年来试验注册政策推动了T2DM相关试验的设计。因此，本研究旨在全面概述在ClinicalTrials.gov数据库中注册的T2DM相关临床试验。
检索ClinicalTrials.gov数据库中注册的T2DM相关临床试验，并评估相关试验的特征。我们在PubMed和谷歌学术上搜索主要完成试验的发表状态。
总体而言，共识别出5117项T2DM相关试验用于分析。在干预性试验中，71.5%具有主要治疗目的，而只有8.9%是预防或卫生服务类。2012年至2019年期间在患者招募前注册的干预性试验比2004年至2011年期间更多（44.6%对19.9%，<0.001）。2012年至2019年期间也有更多试验纳入的参与者少于100名（59.2%对50.9%），为单中心研究（60.7%对50.6%），采用非随机分配（11.3%对6.3%），为开放标签试验（49.2%对45.6%），并且样本量比2004年至2011年期间更小（均<0.001）。试验主要完成后的五年累积发表率<40%。
尽管ClinicalTrials.gov数据库并未涵盖所有临床试验，但在ClinicalTrials.gov数据库中注册的试验仍占大多数临床研究。令人鼓舞的是，多年来在患者招募前注册的干预性试验更多。大多数T2DM相关临床试验专注于药物相关治疗，应推动T2DM预防方面的试验。应更加关注改善临床试验结果的发表和传播。
