New Long-Acting Basal Insulins: Does Benefit Outweigh Cost?

Abstract

Although insulin introduced nearly a century ago has saved the lives of countless people with diabetes, improvements of this therapy continue as significant unmet needs remain (1–4). Even persons with type 2 diabetes who, compared with those with type 1 diabetes, exhibit a much more stable, yet disordered, metabolic milieu only achieve an intended HbA1c target of 7% or lower without hypoglycemic events in a minority of cases (1,3,4). Hypoglycemia and weight gain represent the most important obstacles to achieving the desired glycemic control with insulin therapy, despite major advances in education and empowerment of people with diabetes, the introduction of self-monitoring of blood glucose, improvement in the technical application of insulin, and the availability of a wide array of insulin preparations including insulin analogs (1–4). Intermediate and long-acting basal insulins represent the cornerstone of any insulin therapy regimen, and human NPH insulin, insulin glargine, and insulin detemir are currently the most widely used members of this class of insulin preparations. Discernable progress has been observed with improved day-to-day variability and a lowering in the risk of hypoglycemia with the introduction of the soluble long-acting preparations insulin glargine and insulin detemir compared with NPH insulin, which requires appropriate resuspension prior to administration to reduce variability (5). Against the background of the aforementioned unmet needs, however, a new generation of long-acting basal insulins has emerged aiming at new standards in terms of pharmacokinetics, efficacy, and safety (Fig. 1). Figure 1 Goals of analog design. hypos, hypoglycemia. Modern drug development occurs in an era of increasingly strict regulations by global institutions such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) that rightly demand enhanced safety checks of new chemical entities for clinical use such as the new long-acting insulin …