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

Long, Jianyan; Liu, Ruiming; Zheng, Qiuyi; Yuan, Gang; Xin, Ziyi; Chen, Xinwen; Lai, Fenghua; Liu, Yihao

doi:10.2147/dmso.s288065

Cited by 11 publications

(6 citation statements)

References 44 publications

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“…A possible explanation for the low proportion of completed studies was that as most of these trials (72.5%) had been performed in the last 4 years, and thus the majority of these trials were still ongoing. Among the completed 26 trials, 16 (61.5%) had reported their results on ClinicalTrials.gov, which was significantly higher than the number of trials on other diseases, such as diabetes, that had reported their results (31,33). The most abundant type of study (more than half of the registered studies; 54.8%) was phase 2 trials, followed by phase 1 trials (17.9%) and phase 1-2 trials (13.2%, Figure 3).…”

Section: General Characteristics Of the Registered Clinical Trialsmentioning

confidence: 89%

“…If an industry was listed as the lead funder, the trial was classified as being funded by that industry. If the National Institutes of Health (NIH) was listed as the lead funder, the trial was considered NIH-funded (30,31). According to the recommendations of the American Society for Radiation Oncology (ASTRO), the American Society of Clinical Oncology (ASCO), and the American Urological Association (AUA) evidence-based guidelines, we further classified the RT types into the following three groups according to the radiation fractionation size: conventionally fractionated (1.8-2.0 Gy per fraction), moderately hypofractionated (2.4-3.4 Gy per fraction), and ultra-hypofractionated (5 Gy or more per fraction) (32).…”

Section: Data Extractionmentioning

confidence: 99%

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The characteristics of oncological clinical trials investigating the synergistic effect of radiotherapy and immune checkpoint inhibitors: a cross-sectional study

Chen¹,

Xu²,

Qi³

et al. 2023

Transl Cancer Res

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Background: The combined use of radiotherapy (RT) and immune checkpoint inhibitors (ICIs) is a promising strategy in the treatment of cancer patients. We sought to comprehensively summarize the characteristics of oncological trials investigating the synergistic effect of RT and ICIs registered at ClinicalTrials.gov. Methods:In this cross-sectional study, oncological trials investigating the synergistic effect of RT and ICIs registered at ClinicalTrials.gov from database inception to November 30, 2021 were retrieved. The characteristics of the included trials were assessed.Results: Overall, 403 registered trials were identified for analysis. Of these trials, 393 (97.5%) were interventional trials and 10 (2.5%) were observational trials. The top 3 most-studied conditions were gastrointestinal cancer (25.8%), head and neck cancer (18.6%), and non-small cell lung cancer (NSCLC) (17.9%). Approximately, 60.0% of the trials comprised ≤50 participants and 22.6% of the trials comprised >100 participants. More than half of the registered trials were prospective phase 2 trials (54.3%). In relation to trial location, 39.7% of the trials were conducted in the United States, which was the most common registered area, followed by China (33.7%) and Europe (19.4%). In relation to the radiation fractionation, the conventional fractionation size of 1.8-2.0 Gy was comparable to the ultra-hypofractionation size of ≥5 Gy (46.4% vs. 32.8%), and the most commonly used ultra-hypofractionation regimen was 24 Gy/3 Fx (24%), followed by 25 Gy/5 Fx (11%) and 30 Gy/5 Fx (11%). Additionally, the most commonly used ICI in the registered trials was pembrolizumab (20.1%), followed by durvalumab (11.4%) and nivolumab (9.2%). Among all the registered trials, only 4% of the trials had been completed, but 61.5% of the completed trials had reported their results on ClinicalTrials.gov. The conventional fractionation trials were more likely to be phase 3 trials, located in China, and performed in patients with head and neck cancer or gynecological cancer (all P values <0.05), while the ultra-hypofractionation trials were more likely to be phase 1 trials, stopped early, located in the United States, and performed in patients with lung cancer (all P values <0.05). Conclusions:The number of prospective trials investigating the synergistic effect of RT and ICIs registered at ClinicalTrials.gov has increased significantly over the past decade. The ultra-hypofractionation size of the registered trials varies, but the 24 Gy/3 Fx regimen is commonly used. The clinical results of registered trials examining the synergistic effect of RT in combination with ICIs, specifically in terms of ultra-hypofractionation, remain limited. Highlight box Key findings• Prospective oncological trials investigating the synergistic effect of RT and ICIs registered at ClinicalTrials.gov had been significantly increased, but most of these trials were small sample size, nonrandomized trials and were uncompleted. The fraction size of ultra-hypofractionation size used also varied. What...

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Section: General Characteristics Of the Registered Clinical Trialsmentioning

confidence: 89%

Section: Data Extractionmentioning

confidence: 99%

The characteristics of oncological clinical trials investigating the synergistic effect of radiotherapy and immune checkpoint inhibitors: a cross-sectional study

Chen¹,

Xu²,

Qi³

et al. 2023

Transl Cancer Res

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“…[8] Trials with type 2 diabetes mellitus showed a publication rate of less than 40% of completed trials. [9] The reason is that the current pathogenesis of ITP has not been fully elucidated, and some patients with ITP have poor therapeutic effects, which further promotes more positive results in clinical trials.…”

Section: Discussionmentioning

confidence: 99%

“…Primary immune thrombocytopenia (ITP) manifests as peripheral platelets less than 100×10 9 /L, and other causes of thrombocytopenia should be excluded. This disease, also known as idiopathic thrombocytopenic purpura, is an acquired disease that is immunologically mediated.…”

Section: Introductionmentioning

confidence: 99%

Comprehensive analysis of primary immune thrombocytopenia clinical trials in the ClinicalTrials.gov database

Wang

Yang

et al. 2023

Preprint

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Objective: The purpose is to clarify the overall situation of clinical related to primary immune thrombocytopenia (ITP), to evaluate the difference between published clinical trials and unpublished trials, and to evaluate the relevant information of trial publication. Methods: Search the ClinicalTrials.gov database on March 20, 2022 to identify ITP clinical trials and obtain relevant data. Publications in PubMed were searched using standardized methods to identify the publication of completed clinical trials. Results: Of 341 trials identified, interventional trials were the most common (74.2%, n=253). Interventional trials and observational trials differ in the main research content (odds ratio (OR) 0.06, 95% confidence interval (CI) 0.03-0.015, P=0.000). In terms of published articles, there are few trials involving non drugs (OR 0.23, CI 0.08-0.64, P = 0.005). There were fewer trials with less than 10 participants (OR 1.52, CI 1.06-2.20, P = 0.024). Of the 167 completed trials, 93 (55.7%) were published and 48 (28.7%) uploaded results. Conclusion: If the main research content involves drugs, trials with a larger number of people are more likely to be published. The publication rate of ITP clinical trials is high, but the submission rate of database results is low. Therefore, more attention should be paid to the submission of clinical trial results in the later stage.

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“…DM is linked to an elevated risk of numerous types of diseases and malignancies [1]. The disease's prevalence is anticipated to rise to 623 million by 2045, with type 2 diabetes mellitus (T2DM) accounting for about 90% of cases [2]. Hyperglycemia is a symptom of T2DM caused by insulin resistance and a decrease in insulin production.…”

Section: Introductionmentioning

confidence: 99%

Clinical Prediction of Type 2 Diabetes Mellitus (T2DM) via Anthropometric and Biochemical Variations in Prakriti

et al. 2022

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Type 2 Diabetes Mellitus (T2DM) is a complicated multifactorial illness involving hereditary and external environmental variables. The symptoms typically appear gradually over a number of years without realizing it. This viewpoint is further supported by the Ayurvedic constitution concept (Prakriti). Prakriti explains the biological variability that is observed in different individuals. This study was conducted a retrospective investigation to examine if there was a link between type 2 diabetes and an individual’s constitution based on anthropometric and biochemical characteristics. Physical and mental characteristics and anthropometric and biochemical markers were used to determine reported cases’ prevailing Dosh Prakriti (constitution). Based on biochemical and anthropometric data, significant differences in Prakriti were found between the case (T2DM patients) and control (person without diabetes) groups. The incidence of numerous secondary problems linked with T2DM patients was also evaluated according to their Prakriti types, which revealed a positive relationship. The three primary contributing parameters, such as waist-hip ratio, postprandial blood sugar, and serum creatinine, were correctly classified all person with or without diabetes subjects to 90.6% of the time, whereas the constitution-wise study classified person with diabetes and without diabetes individuals of Pitta and Kapha Prakriti to 94.3% and 90%, respectively. A discriminant function was created to predict a person with diabetes and without diabetes based on these three contributing factors. The primary contributing biochemical parameters discovered by Prakriti in the current study could be used as a biochemical disease diagnostic for predicting type 2 diabetes susceptibility.

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

Cited by 11 publications

References 44 publications

The characteristics of oncological clinical trials investigating the synergistic effect of radiotherapy and immune checkpoint inhibitors: a cross-sectional study

The characteristics of oncological clinical trials investigating the synergistic effect of radiotherapy and immune checkpoint inhibitors: a cross-sectional study

Comprehensive analysis of primary immune thrombocytopenia clinical trials in the ClinicalTrials.gov database

Clinical Prediction of Type 2 Diabetes Mellitus (T2DM) via Anthropometric and Biochemical Variations in Prakriti

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