Long-Acting Human Insulin Analogs

Endogenous insulin is a hormone secreted by the beta cells of the pancreatic islets of Langerhans. Insulin acts via specific membrane-bound receptors on target tissues to regulate metabolism of carbohydrates, proteins and fats. Exogenous insulin, manufactured for pharmacologic use through recombinant DNA technology using either E. coli or Saccharomyces cerevisiae is used as replacement therapy in the management of diabetes mellitus. It supplements deficient levels of endogenous insulin and temporarily restores the ability of the body to properly utilize carbohydrates, fats and proteins. Insulin therapy is indicated in all cases of type 1 diabetes mellitus and in patients with type 2 diabetes mellitus when weight reduction, proper dietary regulation, and/or oral antidiabetic agents have failed to maintain satisfactory concentrations of blood glucose in both the fasting and postprandial state. In addition, insulin is indicated in the treatment of diabetic ketoacidosis and hyperosmolar hyperglycemic states, and in otherwise stable, type 2 diabetic patients in the presence of major surgery, fever, severe trauma, infections, serious renal or hepatic dysfunction, hyperthyroidism or other endocrine dysfunction, gangrene, Raynaud’s disease, or pregnancy.