Abstract
The efficacy and safety of insulin aspart (IAsp), a rapid-acting insulin analogue, were investigated in type 1 diabetes patients treated in a basal-bolus regimen compared to soluble human insulin (HI). IAsp or HI was administered as meal-related insulin immediately (IAsp) or 30 minutes (HI) before meals and basal insulin was administered once or twice daily.
Subjects numbered 143 in the IAsp group and 62 in the HI group.
In the primary endpoint, change of HbAic, mean difference, and 95% confidence interval (C. I.) between the groups were -0.18% and (-0.41, 0.05), and the upper limit of C. I. was less than the upper equivalence margin (0.6%) defined as the non-inferiority criterion. IAsp was thus not inferior to HI in glycemic control measured by HbAic after 24 weeks of treatment. A significant decrease in blood glucose at 90 minutes after breakfast was observed in the IAsp group.
The overall safety profile of IAsp was comparable to that of HI measured by adverse events, clinical laboratory parameters, insulin antibodies, and other parameters.
In conclusion, IAsp was considered useful mealtime insulin applicable even when administered immediately before meals in a multiple-injection regimen.
