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德谷胰岛素院内试验:一项比较德谷胰岛素 U100 和甘精胰岛素 U100 用于 2 型糖尿病住院患者管理的随机对照试验。

Degludec hospital trial: A randomized controlled trial comparing insulin degludec U100 and glargine U100 for the inpatient management of patients with type 2 diabetes.

机构信息

Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.

Department of Medicine, University of Washington, Seattle, Washington, USA.

出版信息

Diabetes Obes Metab. 2022 Jan;24(1):42-49. doi: 10.1111/dom.14544. Epub 2021 Sep 24.

Abstract

AIMS

Limited data exist about the use of insulin degludec in the hospital. This multicentre, non-inferiority, open-label, prospective randomized trial compared the safety and efficacy of insulin degludec-U100 and glargine-U100 for the management of hospitalized patients with type 2 diabetes.

METHODS

In total, 180 general medical and surgical patients with an admission blood glucose (BG) between 7.8 and 22.2 mmol/L, treated with oral agents or insulin before hospitalization were randomly allocated (1:1) to a basal-bolus regimen using degludec (n = 92) or glargine (n = 88), as basal and aspart before meals. Insulin dose was adjusted daily to a target BG between 3.9 and 10.0 mmol/L. The primary endpoint was the difference in mean hospital daily BG between groups.

RESULTS

Overall, the randomization BG was 12.2 ± 2.9 mmol/L and glycated haemoglobin 84 mmol/mol (9.8% ± 2.0%). There were no differences in mean daily BG (10.0 ± 2.1 vs. 10.0 ± 2.5 mmol/L, p = .9), proportion of BG in target range (54·5% ± 29% vs. 55·3% ± 28%, p = .85), basal insulin (29.6 ± 13 vs. 30.4 ± 18 units/day, p = .85), length of stay [median (IQR): 6.7 (4.7-10.5) vs. 7.5 (4.7-11.6) days, p = .61], hospital complications (23% vs. 23%, p = .95) between treatment groups. There were no differences in the proportion of patients with BG <3.9 mmol/L (17% vs. 19%, p = .75) or <3.0 mmol/L (3.7% vs. 1.3%, p = .62) between degludec and glargine.

CONCLUSION

Hospital treatment with degludec-U100 or glargine-U100 is equally safe and effective for the management of hyperglycaemia in general medical and surgical patients with type 2 diabetes.

摘要

目的

关于德谷胰岛素在医院中的应用,目前仅有有限的数据。这项多中心、非劣效性、开放性、前瞻性随机试验比较了德谷胰岛素 U100 与甘精胰岛素 U100 用于治疗 2 型糖尿病住院患者的安全性和疗效。

方法

共纳入 180 例内科和外科住院患者,入院时血糖(BG)为 7.8 至 22.2mmol/L,在住院前使用口服药物或胰岛素治疗。将患者随机(1:1)分为德谷胰岛素组(n=92)或甘精胰岛素组(n=88),两组均接受德谷胰岛素或甘精胰岛素作为基础胰岛素,餐时给予门冬胰岛素。每日调整胰岛素剂量,使 BG 目标值维持在 3.9 至 10.0mmol/L。主要终点是两组间平均住院日 BG 差值。

结果

总体而言,随机 BG 为 12.2±2.9mmol/L,糖化血红蛋白 84mmol/mol(9.8%±2.0%)。两组间平均日 BG(10.0±2.1 与 10.0±2.5mmol/L,p=0.9)、BG 达标比例(54.5%±29%与 55.3%±28%,p=0.85)、基础胰岛素(29.6±13 与 30.4±18 单位/天,p=0.85)、住院时间[中位数(IQR):6.7(4.7-10.5)与 7.5(4.7-11.6)天,p=0.61]和住院并发症发生率(23%与 23%,p=0.95)均无差异。两组间 BG<3.9mmol/L(17%与 19%,p=0.75)或<3.0mmol/L(3.7%与 1.3%,p=0.62)的患者比例也无差异。

结论

对于内科和外科 2 型糖尿病住院患者的高血糖症,德谷胰岛素 U100 或甘精胰岛素 U100 治疗同样安全有效。

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