METAANALYSIS OF THE EFFECT OF INSULIN LISPRO ON SEVERE HYPOGLYCEMIA IN PATIENTS WITH TYPE-1 DIABETES

OBJECTIVE - A precise time-action profile of insulin lispro (Humalog) at mealtime may reduce the incidence of severe hypoglycemia. Because i t is a rare complication, we performed a cumulative meta-analysis to c ompare the frequency of severe hypoglycemia during insulin lispro and human regular insulin therapy in type 1 diabetic patients. RESEARCH DE SIGN AND METHODS - The analysis included eight large multicenter clini cal trials, three with parallel and five with crossover designs. The s tudies included 2,576 type 1 diabetic patients in total, with 2,327 re ceiving insulin lispro and 2,339 receiving regular human insulin, repr esenting >1,400 patient-years of insulin therapy. Severe hypoglycemia was defined as coma or requiring glucagon or intravenous glucose. The patients received either NPH or ultralente as their basal insulin and insulin lispro or regular human insulin before each meal. RESULTS - Se venty-two patients (3.1%) had a total of 102 severe hypoglycemic episo des during insulin lispro therapy, compared with 102 patients (4.4%) w ith a total of 131 episodes during regular human insulin therapy (P = 0.024). CONCLUSIONS - The results of this meta-analysis demonstrate th at in type 1 diabetic patients, the frequency of severe hypoglycemia c an be reduced by taking insulin lispro as compared with regular human insulin therapy.