Institute of Biomedical and Clinical Science, University of Exeter Medical School, University of Exeter, Exeter, Devon, UK.
Department of Mathematical Sciences, University of Bath, Bath, Somerset, UK.
BMJ Open. 2020 Dec 21;10(12):e042784. doi: 10.1136/bmjopen-2020-042784.
Pharmaceutical treatment options for patients with type 2 diabetes mellitus (T2DM) have increased to include multiple classes of oral glucose-lowering agents but without accompanying guidance on which of these may most benefit individual patients. Clinicians lack information for treatment intensification after first-line metformin therapy. Stratifying patients by simple clinical characteristics may improve care by targeting treatment options to those in whom they are most effective. This academically designed and run three-way crossover trial aims to test a stratification approach using three standard oral glucose-lowering agents.
TriMaster is a randomised, double-blind, crossover trial taking place at up to 25 clinical sites across England, Scotland and Wales. 520 patients with T2DM treated with either metformin alone, or metformin and a sulfonylurea who have glycated haemoglobin (HbA) >58 mmol/mol will be randomised to receive 16 weeks each of a dipeptidyl peptidase-4 inhibitor, sodium-glucose co-transporter-2 inhibitor and thiazolidinedione in random order. Participants will be assessed at the end of each treatment period, providing clinical and biochemical data, and their experience of side effects. Participant preference will be assessed on completion of all three treatments. The primary endpoint is HbA after 4 months of therapy (allowing a range of 12-18 weeks for analysis). Secondary endpoints include participant-reported preference between the three treatments, tolerability and prevalence of side effects.
This study was approved by National Health Service Health Research Authority Research Ethics Committee South Central-Oxford A, study 16/SC/0147. Written informed consent will be obtained from all participants. Results will be submitted to a peer-reviewed journal and presented at relevant scientific meetings. A lay summary of results will be made available to all participants.
12039221; 2015-002790-38 and NCT02653209.
治疗 2 型糖尿病（T2DM）患者的药物治疗选择已增加至包括多种口服降糖药物，但缺乏关于哪些药物可能对个体患者最有益的指导。临床医生在一线二甲双胍治疗后缺乏强化治疗的信息。根据简单的临床特征对患者进行分层，可通过将治疗选择针对那些最有效的患者来改善治疗。这项由学术设计和管理的三向交叉试验旨在使用三种标准的口服降糖药物来测试一种分层方法。
TriMaster 是一项在英格兰、苏格兰和威尔士的多达 25 个临床站点进行的随机、双盲、交叉试验。520 名接受二甲双胍单药或二甲双胍联合磺脲类药物治疗且糖化血红蛋白（HbA）>58mmol/mol 的 T2DM 患者将被随机分为四组，每组接受 16 周的二肽基肽酶-4 抑制剂、钠-葡萄糖共转运蛋白-2 抑制剂和噻唑烷二酮治疗，顺序随机。参与者将在每个治疗期结束时进行评估，提供临床和生化数据以及他们对副作用的体验。在完成所有三种治疗后，将评估参与者的偏好。主要终点是治疗 4 个月后的 HbA（允许分析时间为 12-18 周）。次要终点包括三种治疗之间参与者报告的偏好、耐受性和副作用的发生率。
这项研究得到了英国国民保健系统健康研究伦理委员会南中英格兰-牛津 A 区的批准，研究编号 16/SC/0147。所有参与者都将获得书面知情同意。研究结果将提交给同行评议的期刊，并在相关科学会议上进行报告。将向所有参与者提供结果的通俗摘要。
12039221；2015-002790-38 和 NCT02653209。
