Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion - A randomized study in type 1 diabetes

Objective-To compare the safety and efficacy of insulin aspart (IAsp), buffered regular insulin (BR), and insulin lispo administered by continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes. Research Design and Methods-After completing a 4-week run-in period with BR, 146 adult patients with type 1 diabetes (with pretrial CSII experience) were randomly assigned (2:2:1) to CSII treatment with IAsp, Br, or lispro for 16 weeks in a multicenter, open-label, randomized, parallell-group study. Bolus insulin doses were administered 30 min before meals (BR) or immediately before meals (IAsp or lispro). Results-Treatment groups had similar baseline HbA(1c) (7.3%+/-0.7 for IAsp, 7.5%+/-0.8 fore Br, and 8.3%+/-0.7 for lispro). After 16 weeks of treatment, HbA(1c) values were relatively unchanged from baseline and the mean changes in baseline HbA(1c) values were not significantly different between three groups (0.00+/-0.51, 0.15+/-0.63, and 0.18+/-0.84 for the IAsp, BR and lispro groups, respectively). The rates of hypoglycemic episodes (blood glucose <50 mg/dl) per patient per month were similar (3.7, 4.8, and 4.4 for the IAsp, BR, and lispro groups, respectively). Clogs/blockages in pumps or infusion sets were infrequent; most subjects (76, 83, and 75% in the IAsp, BR, and lispro groups, respectively) had <= 1 clog or blockage per weeks during the trial. Conclusions-Insulin aspart in CSII was as efficacious and well tolerated as BR and lispro and is a suitable insulin for continuous subcutaneous insulin infusion using external pumps.