Christiansen Jens Sandahl, Niskanen Leo, Rasmussen Søren, Johansen Thue, Fulcher Greg
Aarhus University Hospital, Aarhus.
Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
J Diabetes. 2016 Sep;8(5):720-8. doi: 10.1111/1753-0407.12355. Epub 2016 Mar 6.
Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the basal analog insulin degludec and the rapid-acting prandial insulin aspart in a single injection. The present combined analysis of two Phase 3a trials compared the incidence of hypoglycemia in participants treated twice daily with IDegAsp or biphasic insulin aspart 30 (BIAsp 30).
Hypoglycemia data were analyzed from two similarly designed randomized controlled open-label treat-to-target Phase 3a clinical trials of adults with type 2 diabetes (T2D). Participants were treated twice daily with IDegAsp or BIAsp 30, with breakfast and their main evening meal.
Over 26 weeks, the rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events were 19%, 57%, and 39% lower, respectively, with IDegAsp (n = 504) than BIAsp 30 (n = 364); estimated rate ratios were 0.81 (95% confidence interval [CI] 0.67, 0.98; P = 0.0341), 0.43 (95% CI 0.31, 0.59; P = 0.0001), and 0.61 (95% CI 0.26, 1.45; P = NS). The between-treatment differences were more pronounced during the maintenance period (≥16 weeks); compared with BIAsp 30, rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events with IDegAsp were 0.69 (95% CI 0.55, 0.87; -31%; P = 0.0015); 0.38 (95% CI 0.25, 0.58; -62%; P < 0.0001), and 0.16 (95% CI 0.04, 0.59; -84%; P = 0.0061), respectively.
Compared with BIAsp 30 twice daily, IDegAsp twice daily provided similar improvements in glycemic control with a lower risk of hypoglycemia, particularly nocturnal hypoglycemia, in subjects with T2D previously treated with insulin.
德谷胰岛素/门冬胰岛素（IDegAsp）是一种基础胰岛素类似物德谷胰岛素和速效餐时胰岛素门冬胰岛素的可溶性复方制剂，可单次注射给药。本项对两项3a期试验的联合分析比较了每日两次接受IDegAsp或双相门冬胰岛素30（BIAsp 30）治疗的参与者的低血糖发生率。
对两项设计相似的随机对照开放标签达标治疗3a期临床试验的低血糖数据进行分析，试验对象为2型糖尿病（T2D）成人患者。参与者每日两次接受IDegAsp或BIAsp 30治疗，分别用于早餐和晚餐。
在26周的时间里，IDegAsp组（n = 504）总体确诊、夜间确诊和严重低血糖事件的发生率分别比BIAsp 30组（n = 364）低19%、57%和39%；估计率比分别为0.81（95%置信区间[CI] 0.67, 0.98；P = 0.0341）、0.43（95% CI 0.31, 0.59；P = 0.0001）和0.61（95% CI 0.26, 1.45；P = 无统计学意义）。治疗组间差异在维持期（≥16周）更为明显；与BIAsp 30相比，IDegAsp组总体确诊、夜间确诊和严重低血糖事件的发生率分别为0.69（95% CI 0.55, 0.87；-31%；P = 0.0015）；0.38（95% CI 0.25, 0.58；-62%；P < 0.0001）和0.16（95% CI 0.04, 0.59；-84%；P = 0.0061）。
与每日两次使用BIAsp 30相比，每日两次使用IDegAsp在血糖控制方面提供了相似的改善，同时低血糖风险更低，尤其是夜间低血糖，在先前接受胰岛素治疗的T2D患者中。
