Back to Journals » Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy » Volume 14

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

Authors Long J, Liang R, Zheng Q, Yuan G, Xin Z, Chen X, Lai F, Liu Y

Received 21 October 2020

Accepted for publication 7 January 2021

Published 26 January 2021 Volume 2021:14 Pages 367—377

DOI https://doi.org/10.2147/DMSO.S288065

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Prof. Dr. Juei-Tang Cheng


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 work

Correspondence: Yihao Liu
Clinical 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 China
Tel +86-20-87755766
Email liuyih3@mail2.sysu.edu.cn
Fenghua Lai
Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, No. 58, ZhongShan Road 2, Guangzhou, Guangdong 510080, People’s Republic of China
Tel +86-20- 87332200
Email laifh@mail2.sysu.edu.cn

Purpose: 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

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]