EFFICACY OF INSULIN LISPRO IN COMBINATION WITH NPH HUMAN INSULIN TWICE PER DAY IN PATIENTS WITH INSULIN-DEPENDENT OR NON-INSULIN-DEPENDENT DIABETES-MELLITUS

A common treatment regimen for patients with either insulin-dependent diabetes mellitus (IDDM) or non-insulin-dependent diabetes mellitus (N IDDM) is a combination of rapid-acting insulin and intermediate-acting insulin administered twice each day. It is usually recommended that r egular human insulin be injected 30 to 45 minutes before a meal. In pr actice, patients often inject regular human insulin closer to mealtime , causing a higher postprandial serum glucose level and an increased p otential for hypoglycemia in the postabsorptive period. Insulin lispro , a rapid-acting insulin analogue, is best injected just before a meal because of its more rapid absorption and shorter duration of action. In 707 randomized patients, 379 with IDDM and 328 with NIDDM, we studi ed the effect of twice-daily insulin lispro or regular human insulin i n combination with NPH human insulin (isophane insulin) on premeal, 2- hour postprandial, and bedtime glycemic control. Assessments were base d on the results of a seven-point blood glucose profile, the insulin d ose (by formulation and time of administration), the incidence and fre quency of hypoglycemic episodes, and the glycated hemoglobin value. Tr eatment with insulin lispro resulted in lower postprandial glucose lev els and smaller increases in glucose level after the morning and eveni ng meals compared with treatment with regular human insulin. Overall g lycemic control, frequency of hypoglycemic events, and total insulin d ose were not different between the two groups. Insulin lispro in combi nation with NPH human insulin in a twice-per-day regimen allows inject ion closer to mealtime and improves postprandial glycemic control with out increasing the risk of hypoglycemia.