'Smart' Basal Insulin Formulation That Releases Insulin in Response to Blood Glucose Concentrations of Diabetic Swine

摘要

An injectable "Smart" basal (SB) insulin formulation with self-regulated basal release ability has been developed. The formulation is referred to as a "smart" formulation since it modifies its release rate of insulin according to the patient's needs at a particular time. The proof of concept of a glucose responsive insulin release was obtained from in vitro and in vivo evaluations. In vitro studies indicated that insulin release from the formulation is glucose concentration dependent. The formulation was further evaluated in a diabetic miniature swine model. Pharmacodymanic (PD) profiles in swine indicated that the amount of insulin released from the SB formulation at the time of first feeding was significantly higher than from the control basal formulation. By three hours after eating, both the basal and SB formulations have similar plasma glucose profiles. Following a second meal challenge, increasing glucose levels led to a more rapid release of SB insulin. Thus, the smart insulin formulation was able to reduce the post meal hyperglycemia that occurred in animals given basal insulin alone.