Novel development of a co-formulation of insulin and Amylin

Abstract

Amylin is a small peptide hormone excreted alongside insulin by pancreatic beta cells. Amylin acts centrally to slow gastric emptying, suppress postprandial glucagon secretion, and decrease food intake, thus complementing the action of insulin to regulate blood glucose levels. In people with type 1 diabetes, amylin production is completely absent. Studies for many years using the stable Amylin, pramlitide have shown that treatment of diabetes with a combination of insulin and amylin analogues at meal times are more effective than insulin alone. However its clinical development is limited due to the impracticality of administering insulin and amylin analogues as two separate injections (since these proteins can't be co-formulated). More recently, investigators from Stanford University have developed a novel formulation which enabled insulin (Humalog Lisipro; Eli Lilly) and Symlin (pramlitide; AstraZeneca) to be given as a single injection. The novel formulation developed by the researchers involves a molecular wrapper made out of polyethylene glycol, engineered to selectively bind to amylin and insulin molecules. This protective element shields the two compounds until they are injected into a body, at which point they unbind from the wrapper and function as normal. The formulation has been tested on animal models and shown to be effective in mimicking the body's endogenous co-secretions of these two important hormones. The formulation has also been found to be stable for over 100 hours, meaning it could be effectively stored and administered by an implanted insulin pump. Further clinical studies are therefore required to show its efficacy in people with type 1 or type 2 diabetes. This recent study on the co-formulation of insulin and Amylin was published in the journal Nature Biomedical Engineering.