Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) DEVOTE 1
Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) DEVOTE 1
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DOI：
10.1016/j.ahj.2016.06.004
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发表时间：
2016-09-01
影响因子：
4.8
通讯作者：
Buse, John B.
中科院分区：
文献类型：
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作者：
Marso, Steven P.;McGuire, Darren K.;Buse, John B.
DEVOTE旨在评估德谷胰岛素（IDeg）与甘精胰岛素U100（IGlar）在心血管事件高风险的T2 D患者中的心血管安全性。DEVOTE是一项3b期、多中心、国际、随机化、双盲、活性对照药物对照试验，设计为事件驱动试验，将持续至累积633例经明确裁定的主要事件。主要终点是从随机化到复合结局的时间，复合结局包括首次发生心血管死亡、非致死性心肌梗死或非致死性卒中。具有心血管并发症高风险的T2D患者以1：1的比例随机接受IDeg或IGlar治疗，每种治疗均添加至背景治疗。本试验旨在证明IDeg相对于IGlar在主要终点方面的统计学非劣效性。2013年10月至2014年11月期间，DEVOTE在20个国家的436家研究中心入组了7，637例患者。其中，6，506名患者既往患有心血管疾病或慢性肾脏疾病，其余患者具有多种心血管风险因素。DEVOTE旨在为T2D高风险患者人群中IDeg相对于IGlar的心血管安全性提供确凿证据。
DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued. The primary end point was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Patients with T2D at high risk of cardiovascular complications were randomized 1:1 to receive either IDeg or IGlar, each added to background therapies. This trial was designed to demonstrate statistical noninferiority of IDeg vs IGlar for the primary end point. DEVOTE enrolled 7,637 patients between October 2013 and November 2014 at 436 sites in 20 countries. Of these, 6,506 patients had prior cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors. DEVOTE was designed to provide conclusive evidence regarding the cardiovascular safety of IDeg relative to IGlar in a high risk population of patients with T2D.