Katakami Naoto, Mita Tomoya, Takahara Mitsuyoshi, Hashigami Kiyoshi, Kawashima Masaru, Shimomura Iichiro, Watada Hirotaka
Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
Department of Metabolism and Atherosclerosis, Graduate School of Medicine, Osaka University, Osaka, Japan.
Diabetes Ther. 2018 Feb;9(1):165-175. doi: 10.1007/s13300-017-0351-7. Epub 2017 Dec 19.
It is estimated that 642 million adults worldwide will have diabetes by 2040, with 80-90% of these having type 2 diabetes mellitus (T2DM). While many new antidiabetic agents have been introduced in recent years, approximately 40% of T2DM patients still fail to achieve the recommended target HbA1c of < 7.0%. Furthermore, many patients with T2DM in Japan are treated by practitioners other than diabetes specialists; therefore, the exact treatment patterns of T2DM in Japan are difficult to quantify.
J-DISCOVER aims to address the lack of data on the management of T2DM by providing real-world data on disease management patterns and associated outcomes in a large number of Japanese T2DM patients who are initiating second-line therapy.
Part of the global DISCOVER study program, J-DISCOVER will follow 2000 T2DM patients recruited from 141 sites across Japan who are aged ≥ 20 years. Recruitment began in September 2014 and follow-up will end in December 2018. The primary objective is to describe the long-term disease management patterns and clinical evolution of patients with T2DM inadequately controlled with a first-line antidiabetic therapy who initiate a second-line antidiabetic treatment. We will assess the associations between treatment patterns, including the line of antidiabetic medication used, as well as clinical and patient-reported outcomes. The primary endpoint is the mean change in HbA1c between baseline and at 6, 12, 24, and 36 months in the overall population and for patients receiving each class of second-line antidiabetic treatment.
A peer-reviewed publication reporting real-world results and implications for clinical practice.
By enrolling and following a large number of patients with T2DM across Japan, J-DISCOVER is expected to provide important real-world clinical data for the development of future T2DM treatment guidelines.
AstraZeneca K.K. and Ono Pharmaceutical Co., Ltd., Osaka Japan.
NCT02226822.
据估计，到2040年全球将有6.42亿成年人患糖尿病，其中80 - 90%为2型糖尿病（T2DM）。尽管近年来引入了许多新型抗糖尿病药物，但仍有大约40%的T2DM患者未能达到推荐的糖化血红蛋白（HbA1c）目标值<7.0%。此外，日本许多T2DM患者由糖尿病专科医生以外的从业者治疗；因此，日本T2DM的确切治疗模式难以量化。
J - DISCOVER旨在通过提供大量开始二线治疗的日本T2DM患者疾病管理模式及相关结局的真实世界数据，来解决T2DM管理方面的数据不足问题。
作为全球DISCOVER研究项目的一部分，J - DISCOVER将对从日本各地141个地点招募的2000例年龄≥20岁的T2DM患者进行随访。招募于2014年9月开始，随访将于2018年12月结束。主要目的是描述一线抗糖尿病治疗控制不佳且开始二线抗糖尿病治疗的T2DM患者的长期疾病管理模式和临床演变。我们将评估治疗模式之间的关联，包括使用的抗糖尿病药物种类，以及临床和患者报告的结局。主要终点是总体人群以及接受各类二线抗糖尿病治疗的患者在基线、6个月、12个月、24个月和36个月时HbA1c的平均变化。
一份经同行评审的出版物，报告真实世界结果及其对临床实践的意义。
通过在日本各地招募并随访大量T2DM患者，J - DISCOVER有望为未来T2DM治疗指南的制定提供重要的真实世界临床数据。
阿斯利康日本公司和日本大阪小野制药有限公司。
NCT02226822。
