Promising New Results for Novo Nordisk’s Next Generation Insulins
Novo Nordisk continues to make headway in the development of Degludec and DegludecPlus, the company’s two new “next-generation” insulins. The company recently announced that enrollment in the phase 3 programs for these drugs, termed BEGIN and BOOST, respectively, had been completed with over 9,000 patients enrolled in the 17 trials – altogether making these programs among the largest for a diabetes therapy in history.
As a quick reminder, Degludec is Novo Nordisk’s new ultra-long acting basal insulin that has the potential to be used once a day or even three times weekly. DegludecPlus is comprised of both Degludec and Novolog, a basal and bolus combination. DegludecPlus offers the advantage of reducing the total number of insulin injections for basal and bolus insulin users (both type 1 and type 2) to just three per day (from the usual four to five)—for instance, if DelgudecPlus is administered prior to breakfast, bolus doses are then needed for lunch and dinner only. For more information on these compounds and their respective clinical trials, please see our New Now Next in diaTribe #22.
Even though trial enrollment was only recently completed, one of the five DegludecPlus trials has already been finished. In this study, two treatment programs were compared in individuals with type 1 diabetes. One program was once-daily DegludecPlus with twice-daily Novolog and the other was once-daily Levemir (Novo Nordisk’s current basal insulin) with three-times-daily Novolog. While no difference was observed between the two treatments in terms of glycemic control (both reduced A1c by 0.8%), those treated with DegludecPlus experienced less hypoglycemia. This was especially true at night, with 33% fewer participants on DegludecPlus reporting a hypoglycemic event. We were concerned, however, that those treated with DegludecPlus did gain slightly more weight on average.
Although data from the Degludec phase 3 trials have not yet been released, we were fortunate enough to hear results presented from the smaller and shorter phase 2 trials for this compound at the American Diabetes Association conference earlier this summer. In comparison to sanofi-aventis’s Lantus (insulin glargine, the most commonly used basal insulin), Degludec given either once-daily or three-times-weekly achieved similar glycemic control and weight change (both were weight neutral). While three-times-weekly administration also produced similar rates of hypoglycemia as Lantus, once-daily degludec actually lowered the risk for hypoglycemia. While we will wait for the longer term phase 3 data before making any conclusions about Degludec, we are certainly intrigued by the possibility for three-times-weekly dosing with this compound. Administered on Monday, Wednesday, and Friday, Degludec could give people who take basal-only insulin the chance to enjoy their weekends without needing to deal with their pens and syringes! --BK
