Novo Nordisk Makes Ground on the Next Generation of Insulins

New insulins on the horizon are designed to be taken three times a week.

We’ve just heard that research at Novo Nordisk is moving quickly on two new insulins, one dubbed “degludec” and the other “degludec plus.” The first is a “next generation” basal insulin (a follow up to Levemir) that patients could take as infrequently as three times per week; the other is a fixed combination of a rapid-acting insulin and the new degludec insulin (a “next generation mix,” as it were).

Eight-thousand patients are now enrolled in clinical trials, and if all goes well, these new insulins will go to the FDA in early 2012. The trial programs are named BEGIN and BOOST, respectively. BEGIN will compare insulin degludec against Lantus in type 2 patients who have never been on insulin, as well as type 1 and type 2 patients on a basal/bolus regimen (known as MDI – multiple daily injections). BOOST will compare the next-generation insulin degludec plus to Levemir/rapid-acting insulin in patients on a basal/bolus regimen. In total, the trials will recruit 10,000 patients – the largest trial ever for a diabetes therapy! Clearly, Novo Nordisk is hoping to persuade some patients currently on Lantus to take one of its next-generation products – in 2009, more than three patients took Lantus for every one that took Levemir, all else equal.

The results for BEGIN and BOOST have yet to come out, but we will be looking for these in the next few months. Although it is difficult to know how much of a improvement these new insulins will have on glycemic control, glycemic variability, and hypoglycemia rates, the company’s head of Research and Development Mads Thompsen has suggested that early-stage studies for degludec show improvements over current insulin analogs that are on par with the improvements between insulin analogs and human insulins (30-35% reductions in hypoglycemia). He also pointed out the dosing flexibility of insulin degludec, noting that patients can give it to themselves in the morning or evening, with “no strings attached,” as well as the potential for three-times weekly dosing.

There are combination therapies on the horizon as well, such as a combination of insulin degludec and Victoza. Advantages of this combination, though much earlier stage, could include weight loss (or no weight gain) and less hypoglycemia than using insulin by itself. --ST