A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes.

摘要

OBJECTIVE: The safety and efficacy of insulin aspart continuous subcutaneous insulin infusion (CSII) was compared with that of insulin lispro CSII in children and adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS: Children and adolescents aged 4-18 years with diagnosed type 1 diabetes >or=1 year previously and treated with insulin analog in a CSII >or=3 months were randomly assigned 2:1 to 16 weeks of insulin aspart CSII (n = 198) or insulin lispro CSII (n = 100) in this open-label, parallel-group, multicenter study. Standard diabetes safety and efficacy parameters were assessed. RESULTS: Baseline demographics, subject characteristics, and diabetes history were similar between treatment groups. After 16 weeks of treatment, insulin aspart CSII was noninferior to insulin lispro CSII as measured by change in A1C from baseline (aspart, -0.15 +/- 0.05%; lispro, -0.05 +/- 0.07% [95% CI of the treatment difference -0.27 to 0.07]; P = 0.241). No significant differences between treatment groups wereobserved in fasting plasma glucose, hyperglycemia, and rates of hypoglycemic episodes. At week 16, 59.7% of subjects in the aspart group and 43.8% of subjects in the lispro groups achieved age-specific American Diabetes Association A1C goals (<8.5% for subjects aged <6 years; <8% for subjects aged 6-18 years) (P = 0.040, corrected for baseline). Daily insulin dose (units per kilogram) was significantly lower at week 16 for subjects treated with aspart compared with those treated with lispro (0.86 +/- 0.237 vs. 0.94 +/- 0.233, P = 0.018). CONCLUSIONS: Insulin aspart was as safe and effective as insulin lispro for use in a CSII in children and adolescents with type 1 diabetes.