Comparative efficacy of humalog mix 75/25 with human Insulin

The study is designed to compare the postprandial glucodynamic profile of humalog mix 75/25, a new premixed insulin analogue containing 75% neutral protamine lispro and 25% insulin lispro with that of human insulin 70/30 in patients with type 2 diabetes mellitus. Insulin lispro mix 75/25 is the first available insulin formulation in which both the rapid-acting and basal components are insulin analogue. Eighty four patients with type 2 diabetes participated in this study and were randomly assigned to 1 of 2 treatment sequence groups. Patients received an identical test meal on 4 occasions, completing 2 test meals for each treatment. Equal doses of mix 75/25 or 70/30 were administered 5 minutes before each of the 2 test meals, with doses individualized for each patients. Blood samples were collected for 4 hours after the meal for measurement of plasma glucose. Because of significant differences in the baseline fasting plasma glucose level between mix 75/25 and 70/30 of these parameters provide a truer comparison of the glucodynamic response between insulin formulations. Mix 75/25 resulted in significantly lower values compared eith 70/30. In patients with type 2 diabetes mellitus pre meal injection of mix 75/25 resulted in better post prandial glycemic control than did pre meal injection of 70/30 in the 4 hours after a standard meal. Mix 75/25 is a valuable option for managing post prandial blood glucose in patient with type 2 diabetes mellitus who require insulin. Key-words: Humalog mix 75/25, insulin 70/30, Diabetes Mellitus. Introduction: All insulins have several anabolic and anticatabolic actions on many tissues in the body. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly, promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat. For patients with type 2 DM who require insulin therapy, achieving optimal glycemic control often requires an insulin regimen containing both basal and prandial insulin components. [1] Insulin analogues are synthetic insulins with small changes in the amino acid sequence made in order to attain better pharmacokinetic characteristics. Both longacting and rapidacting analogues with these characteristics have been developed. Premixed insulin analogues consist of a mixture of a rapid-acting insulin analogue and a slower-acting protaminated form of the analogue in various proportions, to provide both basal and prandial insulin effects in a single injection. Although available in vials, insulin analogue preparations are also available in pen devices to make their use simpler and more discreet for patients, as well as decrease dosing errors. Compared with self-mixed insulins, premixed insulin formulations contain basal and mealtime insulin components, offer convenience and greater dosing accuracy, and play an important role in the treatment of patients with type 2 DM. [2] Insulin lispro is an insulin analogue that is rapidly absorbed after SC injection such that the time-action profile closely mimics the early phase of insulin secretion that is typically diminished in type 2 DM.[3] Premixed insulin formulations containing insulin lispro include insulin lispro 75/25 (75% neutral protamine lispro [NPL] and 25% insulin lispro) and insulin lispro mix 50/50 (50% NPL and 50% insulin lispro). The distinct time-action profiles of the insulin lispro component (rapid acting) and the protamine suspension component Pranay wal et al, /J. Pharm. Sci. & Res. Vol.2(5), 2010, 302-307