Hb. Mortensen et al., Rapid appearance and onset of action of insulin aspart in paediatric subjects with type 1 diabetes, EUR J PED, 159(7), 2000, pp. 483-488
The pharmacokinetics of the novel, rapid-acting insulin aspart were compare
d 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 br
eakfast 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 m
ill (interquartile range: 60-120 min) for human insulin, (P < 0.001). An ag
e-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 insuli
n aspart and human insulin. Postprandial glycaemic control was improved wit
h insulin aspart; the baseline-adjusted Delta C-max glu being lower for ins
ulin 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 wa
s similar for the two insulin types.
Conclusion The more rapid onset of action of insulin aspart versus human in
sulin, previously observed in adults, is confirmed in a paediatric populati
on with type diabetes.