A Randomized Trial Comparing Continuous Subcutaneous Insulin Infusion of Insulin Aspart versus Insulin Lispro in Children and Adolescents with Type 1 Diabetes

doi:10.2337/dc07-1378

A Randomized Trial Comparing Continuous Subcutaneous Insulin Infusion of Insulin Aspart versus Insulin Lispro in Children and Adolescents with Type 1 Diabetes

Stuart A. Weinzimer, MD (stuart.weinzimer{at}yale.edu)¹,
Christine Ternand, MD²,
Campbell Howard, MD³,
Cheng-Tao Chang, PhD³,
Dorothy J. Becker, MB, BCh⁴ and
Lori M.B. Laffel, MD, MPH For the Insulin Aspart Pediatric Pump Study Group⁵

¹Yale University School of Medicine, New Haven, Connecticut
²University of Minnesota Physicians, Minneapolis, Minnesota
³Novo Nordisk Inc., Princeton, New Jersey
⁴Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
⁵Joslin Diabetes Center, Boston, Massachusetts

Abstract

Objective: The safety and efficacy of insulin aspart in continuous subcutaneous insulin infusion (CSII) was compared to that of insulin lispro CSII in children and adolescents with type 1 diabetes.

Research Design and Methods: Children and adolescents 4-18 years of age with diagnosed type 1 diabetes ≥1 year previously treated with insulin analog CSII ≥3 months were randomized 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 non-inferior to insulin lispro CSII as measured by change in HbA_1c from baseline (aspart, −0.15±0.05%; lispro, −0.05±0.07%; 95% CI of the treatment difference, [-0.27, 0.07]; p=0.241). No significant differences between treatment groups were observed in fasting plasma glucose (FPG), 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 ADA HbA_1c goals (<8.5% for subjects < 6 years; <8% for subjects 6-18 years) (p=0.040, corrected for baseline). Daily insulin dose (U/kg) was significantly lower at Week 16 for subjects treated with aspart, as compared to 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 CSII in children and adolescents with type 1 diabetes.