Yeu Rui Qian, Brandon Rebecca, Jiang Yannan, Griffiths Dale, Smallman Kate, Moffitt Allan, Doherty Glenn, Paul Ryan, Harré Hindmarsh Jennie, Merriman Tony R, Macaskill-Smith Kerry, Orr-Walker Brandon, Murphy Rinki
Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.
Auckland Diabetes Centre, Auckland City Hospital, Auckland, New Zealand.
BMJ Open. 2020 Sep 1;10(9):e036518. doi: 10.1136/bmjopen-2019-036518.
There is emerging evidence for stratified glucose-lowering responses to certain oral medications for type 2 diabetes (T2D) by individual characteristics. The objective of this study was to test whether glycaemic response to representative treatments of dipeptidyl peptidase-4 inhibitors (vildagliptin) and thiazolidinediones (pioglitazone) varies according to ethnicity, gender, baseline obesity, triglyceride level or genetic variation.
This is a multicentre, two-period, two-treatment, open-label, randomised cross-over trial of vildagliptin and pioglitazone as second-line or third-line therapy in patients with T2D who have suboptimal glycaemic control on metformin and/or sulfonylurea therapy. It is conducted in New Zealand with a target of 300 patients (40% with Māori or Pacific ancestry) eligible if aged ≥18 and ≤80 years, with T2D for more than 1 year, on stable doses of metformin and/or sulfonylurea for at least 3 months, with HbA1c between 59 and 110 mmol/mol inclusive. Participants are assigned to complete 4 months of vildagliptin 50 mg per day or pioglitazone 30 mg per day, followed by 4 months of the other medications in randomly allocated sequences. Participant characteristics, including ethnicity, obesity, lipid profile and candidate genotypes are collected at baseline. Primary outcome variable is on treatment HbA1c. Secondary outcomes include weight change, frequency of side effects and patient preference.
Ethical approval of the trial has been obtained from the New Zealand Health and Disability Ethics Committee (18/STH/242). The trial commenced in February 2019 and recruitment is expected to be completed by March 2020. Results will be reported in articles submitted to peer-reviewed journals, as well as in presentations at national and international meetings.
ACTRN12618001907235.
越来越多的证据表明，2型糖尿病（T2D）患者对某些口服药物的降糖反应因个体特征而异。本研究的目的是测试二肽基肽酶-4抑制剂（维格列汀）和噻唑烷二酮类药物（吡格列酮）的代表性治疗对血糖的反应是否因种族、性别、基线肥胖、甘油三酯水平或基因变异而有所不同。
这是一项多中心、两阶段、双治疗、开放标签、随机交叉试验，在二甲双胍和/或磺脲类药物治疗血糖控制不佳的T2D患者中，将维格列汀和吡格列酮作为二线或三线治疗药物。该试验在新西兰进行，目标是招募300名患者（40%具有毛利或太平洋岛民血统），年龄≥18岁且≤80岁，患有T2D超过1年，稳定服用二甲双胍和/或磺脲类药物至少3个月，糖化血红蛋白（HbA1c）在59至110 mmol/mol（含）之间。参与者被随机分配，先完成4个月每天服用50 mg维格列汀或30 mg吡格列酮的治疗，然后再进行4个月另一种药物的治疗。在基线时收集参与者的特征，包括种族、肥胖、血脂谱和候选基因型。主要结局变量是治疗期间的HbA1c。次要结局包括体重变化、副作用发生频率和患者偏好。
该试验已获得新西兰健康与残疾伦理委员会（18/STH/242）的伦理批准。试验于2019年2月开始，预计招募工作将于2020年3月完成。研究结果将在提交给同行评审期刊的文章中报告，也会在国内和国际会议上进行展示。
ACTRN12618001907235。
