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

Aims To compare the efficacy of insulin aspart, a rapid-acting insulin anal ogue, with that of unmodified human insulin on long-term blood glucose cont rol in Type 1 diabetes mellitus. Methods Prospective, multi-centre, randomized, open-labelled, parallel-grou p trial lasting 6 months in 88 centres in eight European countries and incl uding 1070 adult subjects with Type 1 diabetes. Study patients were randomi zed 2:1 to insulin aspart or unmodified human insulin before main meals, wi th NPH-insulin as basal insulin. Main outcome measures were blood glucose c ontrol as assessed by HbA(1c), eight-point self-monitored blood glucose pro files, insulin dose, quality of life, hypoglycaemia, and adverse events. Results After 6 months, insulin aspart was superior to human insulin with r espect to HbA(1c) with a baseline-adjusted difference in HbA(1c) of 0.12 (9 5% confidence interval 0.03-0.22) %Hb, P < 0.02. Eight-point blood glucose profiles showed lower post-prandial glucose levels (mean baseline-adjusted -0.6 to -1.2 mmol/l, P < 0.01) after all main meals, but higher pre-prandia l glucose levels before breakfast and dinner (0.7-0.8 mmol/l, P < 0.01) wit h insulin aspart. Satisfaction with treatment was significantly better in p atients treated with insulin aspart (WHO Diabetes Treatment Satisfaction Qu estionnaire (DTSQ) baseline-adjusted difference 2.3 (1.2-3.3) points, P < 0 .001). The relative risk of experiencing a major hypoglycaemic episode with insulin aspart compared to human insulin was 0.83 (0.59-1.18, NS). Major n ight hypoglycaemic events requiring parenteral treatment were less with ins ulin aspart (1.3 vs. 3.4% of patients, P < 0.05), as were late post-prandia l (4-6 h) events (1.8 vs. 5.0% of patients, P < 0.005). Conclusions These results show small but useful advantage for the rapid-act ing insulin analogue insulin aspart as a tool to improve long-term blood gl ucose control, hypoglycaemia, and quality of life, in people with Type 1 di abetes mellitus.