Lane Wendy, Favaro Elena, Jódar Esteban, Kelkar Pranav, Oviedo Alejandra, Sivarathinasami Ramsathish, Senior Peter A, Sesti Giorgio, Franek Edward
Mountain Diabetes and Endocrine Centre, 1998 Hendersonville Rd, Bldg. 31, Asheville, NC, 28803, USA.
Novo Nordisk A/S, Søborg, Denmark.
Diabetes Ther. 2022 Apr;13(4):761-774. doi: 10.1007/s13300-022-01213-3. Epub 2022 Mar 15.
To investigate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) in participants with type 2 diabetes (T2D) across different subgroups.
We report on a post hoc analysis of onset 9, a 16-week trial of participants with T2D randomised to faster aspart (n = 546) or IAsp (n = 545). Participants were grouped by baseline HbA1c (< 7.0%, ≥ 7.0%), meal test bolus insulin dose (≤ 10 units [U], > 10 U to ≤ 20 U, > 20 U), body mass index (< 30 kg/m, ≥ 30 to < 35 kg/m, ≥ 35 kg/m), and age (< 65 years, ≥ 65 years). Outcomes assessed were change from baseline in HbA1c and in 1-h postprandial glucose (PPG) increment, and severe or blood glucose (BG)-confirmed hypoglycaemia.
Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved 1-h PPG control compared with IAsp in several subgroups. Faster aspart had comparable or improved rates of severe or BG-confirmed hypoglycaemia versus IAsp, particularly in participants with good glycaemic control (HbA1c < 7.0%), the elderly (≥ 65 years old), and those with insulin resistance (> 20 U meal test bolus insulin dose).
Faster aspart provides effective overall glycaemic control, with improved early PPG control compared with IAsp across a range of patient characteristics.
NCT03268005.
在不同亚组的2型糖尿病（T2D）患者中，研究门冬胰岛素速效制剂（速效门冬胰岛素）与门冬胰岛素（IAsp）相比的疗效和安全性。
我们报告了对9期起效试验的事后分析，这是一项为期16周的试验，将T2D患者随机分为速效门冬胰岛素组（n = 546）和IAsp组（n = 545）。参与者按基线糖化血红蛋白（HbA1c）（<7.0%，≥7.0%）、餐时大剂量胰岛素剂量（≤10单位[U]，>10 U至≤20 U，>20 U）、体重指数（<30 kg/m²，≥30至<35 kg/m²，≥35 kg/m²）和年龄（<65岁，≥65岁）进行分组。评估的结局指标为HbA1c自基线的变化、餐后1小时血糖（PPG）增加值，以及严重低血糖或血糖（BG）确认的低血糖。
在所有亚组中，速效门冬胰岛素降低HbA1c的效果与IAsp相当，在几个亚组中，其餐后1小时PPG控制优于IAsp。与IAsp相比，速效门冬胰岛素严重低血糖或BG确认的低血糖发生率相当或更低，特别是在血糖控制良好（HbA1c <7.0%）的参与者、老年人（≥65岁）以及胰岛素抵抗者（餐时大剂量胰岛素剂量>20 U）中。
速效门冬胰岛素能有效实现总体血糖控制，在一系列患者特征方面，与IAsp相比，其早期PPG控制更佳。
NCT03268005。
