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A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities
INTRODUCTION: In recent decades, the dramatic rise of obesity among youth in the US has been accompanied by a rise in the prevalence of type 2 diabetes (T2D) in this population. This alarming trend underscores the importance of conducting trials to evaluate new therapies in children with T2D. METHOD...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8519987/ https://www.ncbi.nlm.nih.gov/pubmed/34554411 http://dx.doi.org/10.1007/s13300-021-01136-5 |
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author | Currie, Brooke M. Howell, Timothy A. Matza, Louis S. Cox, David A. Johnston, Joseph A. |
author_facet | Currie, Brooke M. Howell, Timothy A. Matza, Louis S. Cox, David A. Johnston, Joseph A. |
author_sort | Currie, Brooke M. |
collection | PubMed |
description | INTRODUCTION: In recent decades, the dramatic rise of obesity among youth in the US has been accompanied by a rise in the prevalence of type 2 diabetes (T2D) in this population. This alarming trend underscores the importance of conducting trials to evaluate new therapies in children with T2D. METHODS: A targeted review of peer-reviewed literature and trials registered on www.clinicaltrials.gov was conducted in January 2021 to identify pharmaceutical interventional studies in youth with T2D. Information regarding enrollment data, study design elements, subjects’ baseline characteristics, and key treatment outcomes was documented. RESULTS: Among the 16 clinical studies included in this review, only five appeared to meet projected enrollment targets in < 4 years. Although three other studies met recruitment targets, two took approximately 5 years to complete and the third took nearly 10 years. CONCLUSIONS: Despite legislation requiring evaluation of pharmaceutical treatments in pediatric populations, surprisingly few interventional studies have been conducted in children with T2D. This review highlights that recruitment challenges may be impeding the conduct and completion of interventional studies. Consequently, few pharmaceutical treatments have been proven to be effective and approved for children with T2D. Metformin and liraglutide remain the only non-insulin treatments formally approved in the US for use in this population. More clinical research is needed to support regulatory decision-making as well as treatment decisions for children with T2D in clinical settings. Sponsors and investigators will need to implement strategies for improving trial enrollment as well as work with regulatory agencies to develop novel study designs that may require fewer patients. |
format | Online Article Text |
id | pubmed-8519987 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-85199872021-10-29 A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities Currie, Brooke M. Howell, Timothy A. Matza, Louis S. Cox, David A. Johnston, Joseph A. Diabetes Ther Review INTRODUCTION: In recent decades, the dramatic rise of obesity among youth in the US has been accompanied by a rise in the prevalence of type 2 diabetes (T2D) in this population. This alarming trend underscores the importance of conducting trials to evaluate new therapies in children with T2D. METHODS: A targeted review of peer-reviewed literature and trials registered on www.clinicaltrials.gov was conducted in January 2021 to identify pharmaceutical interventional studies in youth with T2D. Information regarding enrollment data, study design elements, subjects’ baseline characteristics, and key treatment outcomes was documented. RESULTS: Among the 16 clinical studies included in this review, only five appeared to meet projected enrollment targets in < 4 years. Although three other studies met recruitment targets, two took approximately 5 years to complete and the third took nearly 10 years. CONCLUSIONS: Despite legislation requiring evaluation of pharmaceutical treatments in pediatric populations, surprisingly few interventional studies have been conducted in children with T2D. This review highlights that recruitment challenges may be impeding the conduct and completion of interventional studies. Consequently, few pharmaceutical treatments have been proven to be effective and approved for children with T2D. Metformin and liraglutide remain the only non-insulin treatments formally approved in the US for use in this population. More clinical research is needed to support regulatory decision-making as well as treatment decisions for children with T2D in clinical settings. Sponsors and investigators will need to implement strategies for improving trial enrollment as well as work with regulatory agencies to develop novel study designs that may require fewer patients. Springer Healthcare 2021-09-23 2021-11 /pmc/articles/PMC8519987/ /pubmed/34554411 http://dx.doi.org/10.1007/s13300-021-01136-5 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Review Currie, Brooke M. Howell, Timothy A. Matza, Louis S. Cox, David A. Johnston, Joseph A. A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities |
title | A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities |
title_full | A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities |
title_fullStr | A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities |
title_full_unstemmed | A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities |
title_short | A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities |
title_sort | review of interventional trials in youth-onset type 2 diabetes: challenges and opportunities |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8519987/ https://www.ncbi.nlm.nih.gov/pubmed/34554411 http://dx.doi.org/10.1007/s13300-021-01136-5 |
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