Rapid appearance and onset of action of insulin aspart in paediatric subjects with type 1 diabetes.

UNLABELLED: The pharmacokinetics of the novel, rapid-acting insulin aspart were compared with those of soluble human insulin following subcutaneous administration in nine children (aged 6-12 years) and nine adolescents (aged 13-17 years) with stable type 1 diabetes. The study had a randomised, double-blind, two-period crossover design. Each patient received a single subcutaneous dose of insulin aspart or human insulin (0.15 IU/kg body weight) 5 min before breakfast and the plasma insulin and glucose concentrations were measured at intervals during the following 5 h. The pharmacokinetic profile of insulin aspart differed significantly from that of human insulin with a higher mean maximum serum insulin (Cmax ins), 881 +/- 321 (SD) pmol/l versus 422 +/- 193 pmol/l for human insulin (P < 0.001); and with a shorter median serum insulin tmax ins, 40.0 min (interquartile range: 40-50 min) versus 75.0 min (interquartile range: 60-120 min) for human insulin, (P < 0.001). An age-related effect on Cmax ins and area under the curve (AUC0-5 h ins) was observed with higher values in adolescents than in children for both insulin aspart and human insulin. Postprandial glycaemic control was improved with insulin aspart; the baseline-adjusted delta Cmax glu being lower for insulin aspart compared with human insulin (increase of 7.6 +/- 5.1 versus 9.4 +/- 4.4 mmol/l respectively, P < 0.05). The incidence of adverse events was similar for the two insulin types.
CONCLUSION: The more rapid onset of action of insulin aspart versus human insulin, previously observed in adults, is confirmed in a paediatric population with type 1 diabetes.

RCT Entities:   Population Interventions Outcomes