Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.
Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Diabetes Obes Metab. 2019 Jul;21(7):1634-1641. doi: 10.1111/dom.13708. Epub 2019 Apr 15.
This study aimed to investigate the safety of insulin degludec (degludec) in relation to age and risk of hypoglycaemia post hoc in individuals with type 2 diabetes (T2D) (SWITCH 2 trial).
In this crossover study, individuals with T2D who were at risk of hypoglycaemia were randomized to double-blind treatment with degludec or insulin glargine 100 units/mL (glargine U100) ± oral antidiabetic drugs. After 32 weeks, patients crossed over to the other treatment. Primary endpoint was number of overall severe (positively adjudicated) or glucose-confirmed (plasma glucose <56 mg/dL; 3.1 mmol/L) symptomatic hypoglycaemia events during the two 16-week maintenance periods.
For individuals ≤65 (n = 450) and >65 (n = 270) years, baseline median (range) duration of diabetes was 12 (1-40) vs 15 (1-54) years, mean HbA1c was 7.7% vs 7.4% and mean estimated glomerular filtration rate was 87.0 vs 63.7 mL/min/1.73 m , respectively. No significant differences in HbA1c reduction were seen in individuals ≤65 or >65 years. During both maintenance periods, treatment with degludec lowered rates of hypoglycaemia (overall/nocturnal symptomatic) vs those with glargine U100 in individuals ≤65 (31% vs 43%) and >65 (30% vs 41%) years. With degludec and glargine U100, respectively, six vs nine severe hypoglycaemic events occurred in individuals ≤65 years and four vs eight events occurred in those >65 years. Adverse event rates were 3.2 and 3.3 events/patient-year for individuals ≤65 years and were 3.5 and 4.1 events/patient-year for individuals >65 years with degludec and glargine U100, respectively.
Treatment with degludec was safe and effective, with a frequency of hypoglycaemia lower than that with glargine U100 in both younger and older individuals (>65 years) with T2D.
本研究旨在探讨胰岛素 Degludec(Degludec)在 2 型糖尿病(T2D)个体中的安全性与年龄及低血糖风险的关系(SWITCH 2 试验)。
在这项交叉研究中,有低血糖风险的 T2D 患者被随机分为两组,接受 Degludec 或甘精胰岛素 100 单位/毫升(甘精 U100)+口服降糖药的双盲治疗。32 周后,患者交叉至另一治疗组。主要终点是两个 16 周维持期内总的(经积极判定的)或经血糖证实(血浆葡萄糖<56mg/dL;3.1mmol/L)有症状的低血糖事件数。
≤65 岁(n=450)和>65 岁(n=270)的个体中,基线时糖尿病的中位(范围)病程分别为 12(1-40)年和 15(1-54)年,平均 HbA1c 分别为 7.7%和 7.4%,平均估算肾小球滤过率分别为 87.0 和 63.7mL/min/1.73m2。≤65 岁和>65 岁的个体中,HbA1c 降低幅度无显著差异。在两个维持期内,与甘精 U100 相比,Degludec 治疗降低了低血糖(总体/夜间有症状)发生率,在≤65 岁(31%比 43%)和>65 岁(30%比 41%)的个体中也是如此。在≤65 岁的个体中,分别有 6 例和 9 例严重低血糖事件发生在 Degludec 和甘精 U100 组,在>65 岁的个体中分别有 4 例和 8 例事件发生。分别有 3.2 例和 3.3 例不良事件/患者年发生在≤65 岁的个体中,有 3.5 例和 4.1 例不良事件/患者年发生在>65 岁的个体中,分别使用 Degludec 和甘精 U100。
在 T2D 年轻(≤65 岁)和老年(>65 岁)个体中,与甘精 U100 相比,Degludec 治疗低血糖的发生频率更低,且安全有效。