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使用德谷胰岛素与 U100 甘精胰岛素相比,2 型糖尿病老年患者低血糖发生率更低:SWITCH 2 研究结果。

Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2.

机构信息

Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.

Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

出版信息

Diabetes Obes Metab. 2019 Jul;21(7):1634-1641. doi: 10.1111/dom.13708. Epub 2019 Apr 15.

Abstract

AIM

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).

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

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)。

方法

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。

结果

≤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。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/42f2/6618254/8d91fea4f581/DOM-21-1634-g001.jpg

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