AIM Treat-to-target, randomized controlled trials have confirmed lower rates of hypoglycaemia at equivalent glycaemic control with insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in patients with type 1 (T1D) or type 2 diabetes (T2D). Treat-to-target trials are designed to enable comparisons of safety and tolerability at a similar HbA1c level. In this post hoc analysis of the SWITCH 1 and 2 trials, we utilised a patient-level modelling approach to compare how glycaemic control might differ between basal insulins at a similar rate of hypoglycaemia. MATERIALS AND METHODS Data for HbA1c and symptomatic hypoglycaemia from the SWITCH 1 and SWITCH 2 trials were analyzed separately for patients with type 1 diabetes and type 2 diabetes, respectively. The association between the individual patient-level risk of hypoglycaemia and HbA1c was investigated using a Poisson regression model and used to estimate potential differences in glycaemic control with degludec versus glargine U100, at the same rate of hypoglycaemia. RESULTS Improvements in glycaemic control increased the incidence of hypoglycaemia with both basal insulins across diabetes types. Our analysis suggests that patients could achieve a mean HbA1c reduction of 0.70 [0.05; 2.20]95% CI (for type 1 diabetes) or 0.96 [0.39; 1.99]95% CI (for type 2 diabetes) percentage points (8 [1; 24]95% CI or 10 [4; 22]95% CI mmol/mol, respectively) further with degludec than with glargine U100 before incurring an equivalent risk of hypoglycaemia. CONCLUSION Our findings suggest that patients in clinical practice may be able to achieve lower glycaemia targets with degludec versus glargine U100, before incurring an equivalent risk of hypoglycaemia.

中文翻译：

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胰岛素地格雷与胰岛素甘精胰岛素100单位/毫升治疗的糖尿病患者中HbA1c与低血糖的关系。

AIM治疗至目标的随机对照试验已证实，在1型（T1D）或2型糖尿病患者中，与地格胰岛素（degludec）相比于甘精胰岛素100单位/ mL（谷氨酰胺U100）等效的血糖控制下低血糖发生率较低T2D）。旨在治疗的目标试验旨在比较相似的HbA1c水平下的安全性和耐受性。在SWITCH 1和SWITCH 2试验的事后分析中，我们采用了患者水平的建模方法来比较基础胰岛素在低血糖发生率相似时血糖控制的差异。材料和方法分别对1型糖尿病和2型糖尿病患者的SWITCH 1和SWITCH 2试验的HbA1c和症状性低血糖数据进行了分析。使用Poisson回归模型研究了个体患者低血糖风险与HbA1c之间的关联，并用于在相同的低血糖发生率下，以地格列克和甘精胰岛素U100评估血糖控制的潜在差异。结果血糖控制的改善增加了两种糖尿病患者两种基础胰岛素的低血糖发生率。我们的分析表明，患者可将HbA1c平均降低0.70 [0.05；2.20] 95％CI（用于1型糖尿病）或0.96 [0.39; 与甘精胰岛素U100相比，地格律生与甘精胰岛素U100相比，1.9％] 95％CI（用于2型糖尿病）的百分率（分别为8 [1; 24] 95％CI或10 [4; 22] 95％CI mmol / mol）要高。低血糖的风险。