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RHAPSODY:2 型糖尿病(T2D)和糖尿病前期的生物标志物和新型临床试验设计。

RHAPSODY, Biomarkers and Novel Clinical Trial design in type 2 diabetes (T2D) and prediabetes.

机构信息

Janssen, High Wycombe, Bucks, UK.

Diabetes UK Wells Lawrence House, London, UK.

出版信息

Endocrinol Diabetes Metab. 2020 Dec 6;4(2):e00207. doi: 10.1002/edm2.207. eCollection 2021 Apr.

DOI:10.1002/edm2.207
PMID:33855210
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8029523/
Abstract

Developing a novel therapeutic product for the treatment of type 2 diabetes (T2D) is a long, resource-intensive process. Novel biomarkers could potentially aid clinical trial design by shortening clinical trials or enabling better prediction of at-risk populations and/or disease progression. Novel clinical trial designs could lead to reduced costs of development and less burden to patients, due to shorter trial duration, and/or less burdensome assessments.

摘要

开发用于治疗 2 型糖尿病 (T2D) 的新型治疗产品是一个漫长而资源密集的过程。新型生物标志物有可能通过缩短临床试验或更好地预测高危人群和/或疾病进展,从而辅助临床试验设计。由于临床试验持续时间更短,以及/或评估负担更小,新型临床试验设计可降低开发成本并减轻患者负担。

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本文引用的文献

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Diabetes Obes Metab. 2018 Oct;20 Suppl 3(Suppl Suppl 3):14-18. doi: 10.1111/dom.13417.
2
Characteristics of high- and low-risk individuals in the PRIORITY study: urinary proteomics and mineralocorticoid receptor antagonism for prevention of diabetic nephropathy in Type 2 diabetes.PRIORITY 研究中高危个体的特征:尿蛋白质组学和醛固酮受体拮抗剂预防 2 型糖尿病肾病。
Diabet Med. 2018 Oct;35(10):1375-1382. doi: 10.1111/dme.13669. Epub 2018 Jun 6.
3
Increasing Patient Involvement in Drug Development.提高患者在药物研发中的参与度。
Value Health. 2016 Sep-Oct;19(6):869-878. doi: 10.1016/j.jval.2016.04.009. Epub 2016 May 24.
4
Circulating TNF receptors 1 and 2 predict ESRD in type 2 diabetes.循环 TNF 受体 1 和 2 可预测 2 型糖尿病的终末期肾病。
J Am Soc Nephrol. 2012 Mar;23(3):507-15. doi: 10.1681/ASN.2011060627. Epub 2012 Jan 19.
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ACE gene polymorphism and losartan treatment in type 2 diabetic patients with nephropathy.2型糖尿病肾病患者的ACE基因多态性与氯沙坦治疗
J Am Soc Nephrol. 2008 Apr;19(4):771-9. doi: 10.1681/ASN.2007050582. Epub 2008 Jan 16.