Series: Cardiovascular outcome trials for diabetes drugs Degludec and DEVOTE

IF 0.4 Q4 ENDOCRINOLOGY & METABOLISM
M. Fisher
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引用次数: 0

Abstract

DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardio-vascular Events) was an FDA-mandated cardiovascular outcome trial and was the first – and at present the only – completed trial comparing two insulins. DEVOTE compared insulin degludec and insulin glargine (U100) in 7,637 people with type 2 diabetes with established cardiovascular disease, chronic kidney disease, or both, and older diabetic patients with increased cardiovascular risk. DEVOTE demonstrated non-inferiority for major cardiovascular events (MACE), a composite of death from cardiovascular causes, non-fatal myocardial infarction and non-fatal stroke, with a pre-specified non-inferiority margin of 1.3. At 24 months the mean HbA1c was similar in the two groups. Mean fasting plasma glucose was significantly lower in the degludec group than in the glargine group, and pre-specified severe hypoglycaemia was also significantly lower in the degludec group. DEVOTE satisfied the FDA cardiovascular safety requirements for new antidiabetic therapies.
系列:糖尿病药物Degludec和dedicated的心血管结局试验
(Degludec胰岛素与甘精胰岛素在2型糖尿病高危心血管事件患者中的心血管安全性比较试验)是fda授权的一项心血管结局试验,是第一个也是目前唯一一个完成的比较两种胰岛素的试验。在7,637例伴有心血管疾病、慢性肾脏疾病或两者兼有的2型糖尿病患者和心血管风险增加的老年糖尿病患者中,对degludec胰岛素和甘精胰岛素(U100)进行了比较。对主要心血管事件(MACE),包括心血管原因导致的死亡、非致死性心肌梗死和非致死性中风的复合死亡,预先设定的非劣效性裕度为1.3。在24个月时,两组的平均HbA1c相似。degludec组的平均空腹血糖明显低于甘精组,预先指定的严重低血糖也明显低于degludec组。在新的抗糖尿病疗法中,dedicated满足FDA心血管安全要求。
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来源期刊
British Journal of Diabetes
British Journal of Diabetes ENDOCRINOLOGY & METABOLISM-
自引率
16.70%
发文量
15
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