Use of insulin lispro in continuous subcutaneous insulin infusion treatment - Results of a multicenter trial

OBJECTIVE - Insulin lispro is an analog of human insulin with a faster onse t and a shorter duration of action than regular human insulin. Efficacy and tolerability of insulin lispro in continuous subcutaneous insulin infusion (CSII) treatment were assessed in an open randomized crossover trial compa ring insulin lispro and regular human insulin, both applied with insulin pu mps. RESEARCH DESIGN AND METHODS - A total of 113 type 1 patients (60 male, 53 f emale, age [mean +/- SD] 37 +/- 12 years, duration of diabetes 19 +/- 9 yea rs) participated in this open, randomized crossover stud): Both insulins we re applied for 4 months each with the appropriate intervals between the pra ndial insulin bolus and the meal(human insulin: 30 min; lispro: 0 min). Obs ervation parameters were HbA(1c), daily and postprandial blood glucose prof iles, adverse events, rate of hypoglycemic and hyperglycemic events, number of catheter obstructions, and treatment satisfaction as assessed with an i nternational validated questionnaire. RESULTS - The patients were well controlled with a mean HbA(1c) of 7.24 +/- 1.0% at baseline. HbA(1c) decreased in both treatment periods, but it was better during insulin lispro treatment (insulin lispro: 6.8 +/- 0.9%, regul ar human insulin: 6.9 +/- 1.0% Friedman's rank-sum test: P < 0.02), In addi tion, the 1-h and 2-h postprandial rises in blood glucose were significantl y lower (P < 0.001 for each meal) with insulin lispro, resulting in smoothe r daily glucose profiles as compared with regular human insulin, No signifi cant differences were reported for the rare of hypoglycemia (mean +/- SD [m edian]: insulin lispro 12.4 +/- 13.9 [8], regular human insulin 11.0 +/- 11 .2 [8]), for the rate of catheter obstructions (42 events in each treatment arm), and for the number and type of adverse events. No severe case of ket oacidosis was seen during insulin lispro treatment, whereas one case was re ported during therapy with regular human insulin. Treatment satisfaction wa s better when patients were treated with insulin lispro, CONCLUSIONS - Insulin lispro is a suitable and very convenient pump insulin that may result in an improvement of long-term glucose control during CSII treatment. Its safety profile does not differ from that of regular human i nsulin.