Objective. This study compared the glucose-lowering effect of insulin lispr
o, given before or after meals, with regular human insulin given before mea
ls in prepubertal children with diabetes.
Research Design and Methods. A 3-way crossover, open-label study involving
61 prepubertal children (ages 2.9-11.4 years) with type 1 diabetes. The chi
ldren were randomly assigned to receive regular human insulin 30 to 45 minu
tes before meals, insulin lispro within 15 minutes before or immediately af
ter meals, combined with basal insulin. Each treatment lasted 3 months. Hem
oglobin A(1c) levels and home glucose monitoring profiles were measured at
the end of each treatment period.
Results. Treatment with insulin lispro before breakfast resulted in lower 2
-hour postprandial glucose values than regular human insulin (11.7 +/- 4.4
mmol/L vs 15.0 +/- 5.4 mmol/L). Similarly, insulin lispro given before dinn
er resulted in lower blood glucose values 2 hours postprandially (8.8 +/- 5
.0 mmol/L vs 10.8 +/- 5.4 mmol/L) than regular human insulin. When insulin
lispro was administered after meals, the 2-hour glucose levels were between
those seen with either insulin lispro or regular human insulin given befor
e meals. The number and types of adverse events, the rates of hypoglycemia,
and the HbA(1c) levels did not differ among the 3 therapies.
Conclusions. In prepubertal children, insulin lispro given before meals is
safe and significantly lowers postprandial glucose levels after breakfast a
nd dinner compared with regular human insulin, and insulin lispro given aft
er the meal provides similar benefits as regular human insulin before the m
eal.