Degludec and degludecPlus Submitted for Approval in the US and Europe

In October, Novo Nordisk announced that it had submitted its two new “next-generation” insulin products for approval in both the US and Europe (and Japan to follow soon!). The first product, called degludec, is an ultra-long acting basal insulin. The second product, called degludecPlus, is a fixed-dose combination of basal and mealtime insulin (70% degludec and 30% NovoLog). Overall, in studies in people with type 1 and type 2 diabetes, degludec was demonstrated to provide similar improvements in blood glucose control as Lantus – the currently leading basal insulin – while also reducing the rate of overall and nocturnal hypoglycemia (see New Now Next in diaTribe issue #33). This lower rate of hypoglycemia is thought to result from the drug’s long (42 hours or more) and consistent action in the body. One study found that degludec’s long duration of action makes it possible to dose the drug at different times each day (i.e., in the morning one day, the evening the next day, the morning the day after that) without sacrificing effectiveness and safety. Although we imagine that dosing at roughly the same time each day would make sense for most people, having the flexibility to vary the time of day when needed could be positive for patients. The opportunity to dose degludec flexibly would be an improvement over current basal insulins, which require dosing at the same time each day to maintain sufficient insulin levels in the body and to avoid hypoglycemia. Finally, degludec will also come in a U-200 version (twice as concentrated as usual). The U-200 version will help reduce injection volumes for people with greater insulin requirements. If all goes according to plan, both degludec and degludecPlus may be approved in both the US and Europe in the second half of 2012. --BK