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甘精胰岛素 300U/ml 和德谷胰岛素 100U/ml 起始胰岛素治疗后的积极滴定期间血糖控制相似且低血糖发生率更低:BRIGHT 研究的一项亚组分析。

Similar glycaemic control and less hypoglycaemia during active titration after insulin initiation with glargine 300 units/mL and degludec 100 units/mL: A subanalysis of the BRIGHT study.

机构信息

Department of Medicine, University of Toronto, Toronto, Canada.

Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.

出版信息

Diabetes Obes Metab. 2020 Mar;22(3):346-354. doi: 10.1111/dom.13901. Epub 2019 Dec 20.

Abstract

AIM

To further investigate glycaemic control and hypoglycaemia in BRIGHT, focusing on the titration period.

MATERIALS AND METHODS

BRIGHT was a multicentre, open-label, randomized, active-controlled, two-arm, parallel-group, 24-week study in insulin-naïve patients with uncontrolled type 2 diabetes initiated on glargine 300 U/mL (Gla-300) (N = 466) or degludec (IDeg-100) (N = 463). Predefined efficacy and safety outcomes were investigated during the initial 12-week titration period. In addition, patients' characteristics and clinical outcomes were assessed descriptively, stratified by confirmed (≤3.9 mmol/L) hypoglycaemia incidence during the initial titration period.

RESULTS

At week 12, HbA1c was comparable between Gla-300 (7.32%) and IDeg-100 (7.23%), with similar least squares (LS) mean reductions from baseline (-1.37% and - 1.39%, respectively; LS mean difference of 0.02; 95% confidence interval: -0.08 to 0.12). Patients who experienced hypoglycaemia during the initial titration period had numerically greater HbA1c reductions by week 12 than patients who did not (-1.46% vs. -1.28%), and higher incidence of anytime (24 hours; 73.3% vs. 35.7%) and nocturnal (00:00-06:00 hours; 30.0% vs. 11.9%) hypoglycaemia between weeks 13-24.

CONCLUSIONS

The use of Gla-300 resulted in similar glycaemic control as IDeg-100 during the initial 12-week titration period of the BRIGHT study, when less anytime (24 hours) hypoglycaemia with Gla-300 versus IDeg-100 has been reported. Experiencing hypoglycaemia shortly after initiating Gla-300 or IDeg-100 may be associated with hypoglycaemia incidence in the longer term, potentially impacting glycaemic management.

摘要

目的

进一步研究 BRIGHT 中的血糖控制和低血糖情况,重点关注滴定期。

材料和方法

BRIGHT 是一项多中心、开放标签、随机、阳性对照、双臂、平行组、24 周研究,纳入了起始接受甘精胰岛素 300U/mL(Gla-300)(N=466)或德谷胰岛素(IDeg-100)(N=463)治疗的未经治疗的 2 型糖尿病患者。在初始的 12 周滴定期内,对预设的疗效和安全性结局进行了研究。此外,还根据初始滴定期内确诊(≤3.9mmol/L)低血糖发生率,对患者特征和临床结局进行了描述性评估。

结果

在第 12 周时,Gla-300(7.32%)和 IDeg-100(7.23%)的糖化血红蛋白(HbA1c)水平相当,自基线的最小二乘均数(LS)降幅也相似(分别为-1.37%和-1.39%;LS 均值差值为 0.02;95%置信区间:-0.08 至 0.12)。在初始滴定期经历低血糖的患者,到第 12 周时的 HbA1c 降幅大于未发生低血糖的患者(-1.46% vs. -1.28%),并且在第 13-24 周期间,24 小时任意时间(73.3% vs. 35.7%)和夜间(00:00-06:00 小时;30.0% vs. 11.9%)低血糖的发生率更高。

结论

在 BRIGHT 研究的初始 12 周滴定期,甘精胰岛素 300 导致的血糖控制与德谷胰岛素 100 相当,而此前报告称,甘精胰岛素 300 较德谷胰岛素发生的任意时间(24 小时)低血糖更少。在起始接受甘精胰岛素 300 或德谷胰岛素治疗后不久即发生低血糖,可能与长期低血糖的发生率有关,这可能会影响血糖管理。

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