Department of Medicine, Perugia University Medical School, Perugia, Italy.
Division of Endocrinology and Metabolism, University of Toronto, Toronto, Ontario, Canada.
Diabetes Obes Metab. 2021 Jul;23(7):1588-1593. doi: 10.1111/dom.14372. Epub 2021 Apr 1.
To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus insulin degludec 100 U/mL (IDeg-100) in predefined (</≥65 years) and post hoc (</≥70 years) age groups of people with type 2 diabetes (T2D) in the BRIGHT trial.
BRIGHT was the first head-to-head randomized trial comparing Gla-300 and Deg-100 in insulin-naïve adults with T2D. In this subanalysis, endpoints were studied by predefined (</≥65 years, N = 596/333) and post hoc (</≥70 years, N = 768/161) age groups.
Heterogeneity of treatment effect was observed for HbA1c reductions across the </≥70 years subgroups, but not across the </≥ 65 years subgroups, with greater HbA1c reductions with Gla-300 versus IDeg-100 in those 70 years or older (least squares mean -0.34% [95% confidence interval: -0.589% to -0.100%]). There was no significant heterogeneity of treatment effect for incidence and rates of confirmed (≤3.9 mmol/L [≤70 mg/dL]) hypoglycaemia across any age subgroups over 24 weeks, but numerically lower incidence and rates were consistently observed for Gla-300 versus IDeg-100 in the 65 years or older and 70 years or older age groups in the initial 12 weeks.
Gla-300 may be a suitable treatment option in the growing population of older people with T2D. Further investigation is required to determine Gla-300 glycaemic benefits in high-risk populations without increasing the risk of hypoglycaemia.
评估甘精胰岛素 300U/mL(Gla-300)与德谷胰岛素 100U/mL(IDeg-100)在 BRIGHT 试验中 2 型糖尿病(T2D)患者的预设(</≥65 岁)和事后(</≥70 岁)年龄组中的疗效和安全性。
BRIGHT 是首次头对头比较 Gla-300 和 Deg-100 在胰岛素初治的 T2D 成人中的随机试验。在这项亚分析中,根据预设(</≥65 岁,N=596/333)和事后(</≥70 岁,N=768/161)年龄组研究终点。
在 </≥70 岁亚组中,观察到 HbA1c 降低的治疗效果存在异质性,但在 </≥65 岁亚组中没有,Gla-300 与 IDeg-100 相比,70 岁或以上患者的 HbA1c 降低更明显(最小二乘均值-0.34% [95%置信区间:-0.589%至-0.100%])。在 24 周内,任何年龄亚组的低血糖发生率和发生率均无显著治疗效果的异质性,但在 65 岁或以上和 70 岁或以上年龄组中,Gla-300 与 IDeg-100 相比,低血糖的发生率和发生率均较低。
Gla-300 可能是 T2D 老年患者人群中不断增长的合适治疗选择。需要进一步研究以确定 Gla-300 在没有增加低血糖风险的情况下对高危人群的血糖益处。