PMID- 33531823
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240330
IS  - 1178-7007 (Print)
IS  - 1178-7007 (Electronic)
IS  - 1178-7007 (Linking)
VI  - 14
DP  - 2021
TI  - Overview of Clinical Trials on Type 2 Diabetes Mellitus: A Comprehensive Analysis 
      of the ClinicalTrials.gov Database.
PG  - 367-377
LID - 10.2147/DMSO.S288065 [doi]
AB  - 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.
CI  - (c) 2021 Long et al.
FAU - Long, Jianyan
AU  - Long J
AD  - Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, 
      Guangzhou 510080, People's Republic of China.
FAU - Liang, Ruiming
AU  - Liang R
AD  - Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, 
      Guangzhou 510080, People's Republic of China.
FAU - Zheng, Qiuyi
AU  - Zheng Q
AD  - Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, 
      Guangzhou 510080, People's Republic of China.
AD  - Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou 510080, People's Republic of China.
FAU - Yuan, Gang
AU  - Yuan G
AD  - Phase I Clinical Trial Center, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou 510080, People's Republic of China.
FAU - Xin, Ziyi
AU  - Xin Z
AD  - Department of Medical Records, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou 510080, People's Republic of China.
FAU - Chen, Xinwen
AU  - Chen X
AD  - Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou 510080, People's Republic of China.
FAU - Lai, Fenghua
AU  - Lai F
AUID- ORCID: 0000-0002-3562-7132
AD  - Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou 510080, People's Republic of China.
FAU - Liu, Yihao
AU  - Liu Y
AUID- ORCID: 0000-0003-3270-9797
AD  - Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, 
      Guangzhou 510080, People's Republic of China.
AD  - Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou 510080, People's Republic of China.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20210126
PL  - New Zealand
TA  - Diabetes Metab Syndr Obes
JT  - Diabetes, metabolic syndrome and obesity : targets and therapy
JID - 101515585
PMC - PMC7847376
OTO - NOTNLM
OT  - ClinicalTrials.gov
OT  - clinical trials
OT  - publication status
OT  - type 2 diabetes mellitus
COIS- The authors report no conflicts of interest in this work.
EDAT- 2021/02/04 06:00
MHDA- 2021/02/04 06:01
PMCR- 2021/01/26
CRDT- 2021/02/03 05:58
PHST- 2020/10/21 00:00 [received]
PHST- 2021/01/07 00:00 [accepted]
PHST- 2021/02/03 05:58 [entrez]
PHST- 2021/02/04 06:00 [pubmed]
PHST- 2021/02/04 06:01 [medline]
PHST- 2021/01/26 00:00 [pmc-release]
AID - 288065 [pii]
AID - 10.2147/DMSO.S288065 [doi]
PST - epublish
SO  - Diabetes Metab Syndr Obes. 2021 Jan 26;14:367-377. doi: 10.2147/DMSO.S288065. 
      eCollection 2021.