Paquot N, Scheen A J
Service de Diabétologie, Nutrition et Maladies métaboliques, CHU Sart Tilman, Liège, Belgique.
Service de Diabétologie, Nutrition et Maladies métaboliques et Unité de Pharmacologie clinique, CHU Sart Tilman, Liège, Belgique.
Rev Med Liege. 2018 Apr;73(4):211-215.
Fast-acting insulin aspart (faster aspart), commercialized under the trade name of Fiasp®, is insulin aspart in a new formulation aiming to mimic the physiologic prandial insulin release more closely than currently available rapid-acting insulin products. Fiasp® is insulin aspart (NovoRapid®) in which two excipients (L-arginine and niacinamide) have been added, L-arginine serving as a stabilising agent, while niacinamide being responsible for accelerated initial absorption after subcutaneous administration. The pharmacokinetic characteristics of insulin faster aspart have the potential to better reproduce the fast endogenous prandial insulin secretion and thereby to improve postprandial glucose control compared with insulin aspart. The onset phase 3 programme compares head-to-head insulin faster aspart to insulin aspart. Studies showed significant reductions in postprandial glucose increment (in type 1 and type 2 diabetic patients), and glycated haemoglobin (HbA1C, in type 1 diabetes), without markedly increasing the risk of hypoglycaemia. A post hoc analysis of pooled data from six clinical trials conducted in patients with type 1 diabetes confirmed the beneficial pharmacokinetic and pharmacodynamic profiles of insulin faster aspart (earlier plasma insulin appearance, early insulin exposure two times greater and earlier offset of exposure of insulin faster aspart versus insulin aspart).
门冬胰岛素速溶（速溶门冬胰岛素），商品名为Fiasp®，是一种新型配方的门冬胰岛素，旨在比目前可用的速效胰岛素产品更紧密地模拟生理性餐时胰岛素释放。Fiasp®是在门冬胰岛素（诺和锐®）中添加了两种辅料（L-精氨酸和烟酰胺），L-精氨酸作为稳定剂，而烟酰胺负责皮下给药后加速初始吸收。与门冬胰岛素相比，门冬胰岛素速溶的药代动力学特征有可能更好地重现内源性餐时胰岛素的快速分泌，从而改善餐后血糖控制。3期起始阶段研究将门冬胰岛素速溶与门冬胰岛素进行了直接比较。研究表明，（在1型和2型糖尿病患者中）餐后血糖增量以及（在1型糖尿病中）糖化血红蛋白（HbA1C）显著降低，且未明显增加低血糖风险。对1型糖尿病患者进行的六项临床试验汇总数据的事后分析证实了门冬胰岛素速溶有益的药代动力学和药效学特征（与门冬胰岛素相比，门冬胰岛素速溶的血浆胰岛素出现更早、早期胰岛素暴露量高两倍且暴露结束更早）。
