Department of Medicine, University of Toronto, Toronto, Canada.
Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
Diabetes Obes Metab. 2020 Mar;22(3):346-354. doi: 10.1111/dom.13901. Epub 2019 Dec 20.
To further investigate glycaemic control and hypoglycaemia in BRIGHT, focusing on the titration period.
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.
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.
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.
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。
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。
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。
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。