Overview of Clinical Trials on Type 2 Diabetes Mellitus: A Comprehensive Analysis of the ClinicalTrials.gov Database

Abstract

Jianyan Long,1,* Ruiming Liang,1,* Qiuyi Zheng,1,2 Gang Yuan,3 Ziyi Xin,4 Xinwen Chen,2 Fenghua Lai,2 Yihao Liu1,2 1Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, People’s Republic of China; 2Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, People’s Republic of China; 3Phase I Clinical Trial Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, People’s Republic of China; 4Department of Medical Records, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yihao LiuClinical Trials Unit, Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, No. 58, ZhongShan Road 2, Guangzhou, Guangdong 510080, People’s Republic of ChinaTel [phone]Email [email protected] LaiDepartment of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, No. 58, ZhongShan Road 2, Guangzhou, Guangdong 510080, People’s Republic of ChinaTel [phone]Email [email protected]: 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.Methods: 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.Results: 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%, P< 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 P< 0.001). The five-year cumulative publication rates after primary completion of the trials were < 40%.Conclusion: 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.Keywords: clinical trials, type 2 diabetes mellitus, ClinicalTrials.gov, publication status

Keywords

• clinical trials
• type 2 diabetes mellitus
• clinicaltrials.gov
• publication status