Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial

SUMMARY Aims To compare the efficacy of insulin aspart, a rapid‐acting insulin analogue, with that of unmodified human insulin on long‐term blood glucose control in Type 1 diabetes mellitus. Methods Prospective, multi‐centre, randomized, open‐labelled, parallel‐group trial lasting 6 months in 88 centres in eight European countries and including 1070 adult subjects with Type 1 diabetes. Study patients were randomized 2:1 to insulin aspart or unmodified human insulin before main meals, with NPH‐insulin as basal insulin. Main outcome measures were blood glucose control as assessed by HbA1c, eight‐point self‐monitored blood glucose profiles, insulin dose, quality of life, hypoglycaemia, and adverse events. Results After 6 months, insulin aspart was superior to human insulin with respect to HbA1c with a baseline‐adjusted difference in HbA1c of 0.12 (95% confidence interval 0.03–0.22) %Hb, P