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 (C
max ins), 881 ± 321 (SD) pmol/l versus 422 ± 193 pmol/l for human insulin (
P < 0.001); and with a shorter median serum insulin
t
max 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 C
max ins and area under the curve (AUC
0–5h 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 ΔC
max 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.
Key words Insulin aspart - Insulin analogue - Type 1 diabetes - Pharmacokinetics - Children
Received: 30 June 1999 and in revised form: 20 September 1999 and 23 November 1999 /Accepted: 9 December 1999