Abstract :
[en] Fast-acting insulin aspart (faster aspart), commercialized under the trade name of Fiasp(R), 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(R) is insulin aspart (NovoRapid(R)) 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).
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