Department of Medicine, Division of Endocrinology, Duke University School of Medicine, Duke University, Durham, North Carolina, USA.
Novo Nordisk A/S, Søborg, Denmark.
Diabetes Obes Metab. 2021 Aug;23(8):1983-1988. doi: 10.1111/dom.14397. Epub 2021 May 6.
In the DEVOTE and SWITCH 2 trials, insulin degludec 100 units/mL (degludec) was superior to insulin glargine 100 units/mL (glargine U100) with respect to the rates of severe (DEVOTE; across trial) and overall symptomatic (SWITCH 2; during the maintenance period of the trial) hypoglycaemia in individuals with type 2 diabetes. In this post hoc analysis, data from 7635 individuals from DEVOTE and 720 individuals from SWITCH 2 were analysed by subgroups of diabetes duration at baseline (<10, ≥10-<15, ≥15-<20 and ≥20 years) using prespecified models from both trials. There was a trend towards lower rates of hypoglycaemia with degludec versus glargine U100 across all diabetes duration subgroups in both trials, with the difference being statistically significant in some subgroups in DEVOTE and SWITCH 2. Overall, however, no significant interaction was observed between diabetes duration and treatment (DEVOTE interaction, P = .496; SWITCH 2 interaction, P = .144). Therefore, in this post hoc analysis of DEVOTE and SWITCH 2, diabetes duration did not appear to affect the reduction in rates of hypoglycaemia observed with degludec compared with glargine U100.
在 DEVOTE 和 SWITCH 2 两项试验中，与胰岛素甘精 U100 相比，胰岛素地特胰岛素 100 单位/毫升（地特胰岛素）在 2 型糖尿病患者的严重低血糖（DEVOTE；整个试验）和总体症状性低血糖（SWITCH 2；试验维持期）发生率方面具有优势。在这项事后分析中，对来自 DEVOTE 的 7635 名个体和来自 SWITCH 2 的 720 名个体的数据，根据基线时的糖尿病病程（<10 年、≥10-<15 年、≥15-<20 年和≥20 年），使用来自两项试验的预先设定模型进行了亚组分析。在两项试验的所有糖尿病病程亚组中，与甘精 U100 相比，地特胰岛素的低血糖发生率均呈下降趋势，在 DEVOTE 和 SWITCH 2 中的某些亚组中差异具有统计学意义。然而，总体而言，糖尿病病程与治疗之间未观察到显著的交互作用（DEVOTE 交互作用，P=0.496；SWITCH 2 交互作用，P=0.144）。因此，在 DEVOTE 和 SWITCH 2 的这项事后分析中，糖尿病病程似乎并未影响与甘精 U100 相比地特胰岛素降低低血糖发生率的效果。
