Objective: To compare rapid-acting insulin analogues with regular human insulin in terms of hemoglobin A1c, hypoglycemia, and insulin dose when used in a basal-bolus regimen in patients with type 1 diabetes mellitus.
Methods: MEDLINE and congress proceedings were searched for randomized controlled trials comparing prandial insulins in a basal-bolus regimen in adults or children/adolescents with type 1 diabetes. Studies in pregnancy, observational studies, studies that compared premixed insulin or continuous subcutaneous insulin infusion/insulin pumps, and studies where the basal insulin was also changed were excluded. Only studies reporting baseline-endpoint change in insulin dose, or baseline and/or endpoint values, were included.
Results: Twenty-eight studies were identified (insulin glulisine, 4; insulin aspart, 7; insulin lispro, 17). Twenty-five studies compared a rapid-acting insulin analogue with regular human insulin, and 3 trials compared 2 rapid-acting insulin analogues. Overall, rapid-acting insulin analogues in a basal-bolus regimen provided similar or greater improvements in glycemic control than regular human insulin at similar insulin doses, as well as a lower incidence of hypoglycemia.
Conclusions: Results of the studies identified in this literature review indicate that a basal-bolus regimen with prandial rapid-acting insulin analogue provides advantages over basal-bolus regimens using prandial regular human insulin, providing improvements in glycemic control comparable to those obtained with regular human insulin, as well as a lower incidence of hypoglycemia.