Data from two new studies shows patients with type 2 diabetes starting insulin therapy had a 43% lower rate of night-time hypoglycemia when using degludec, Novo Nordisk’s ultra-long-acting insulin, compared with those using insulin glargine (Lantus).
A 2-year (1 year initial and 1 year extension) phase 3a study, comparing the efficacy and safety of once-daily insulin degludec versus once-daily Lantus (insulin glargine) (both in combination with OADs), found the rates of overall hypoglycemia were similar between the two groups. But while the rates of severe hypoglycemia were infrequent, they were significantly lower with insulin degludec than with insulin glargine. This randomized, open-label, treat-to-target study included 1,030 patients with type 2 diabetes not previously treated with insulin, of which 659 completed 2 years of treatment.
The results of this study were presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD), in Berlin, Germany.
In a separate, prospectively planned meta-analysis also presented at EASD, patient level data from 4,330 patients in seven randomized, open-label, treat-to- target phase 3a trials of 26 or 52 weeks showed that insulin degludec significantly reduced the rate of night-time hypoglycemia in adults with type 1 and type 2 diabetes, while obtaining equivalent improvements in glucose control, when compared with Lantus (insulin glargine).
Insulin degludec is a basal insulin analogue discovered and developed by Novo Nordisk. It has an ultra-long duration of action that extends beyond 42 hours with a flat and stable profile.
Insulin degludec was submitted for once-daily use to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in September 2011 for regulatory review.
On 28 September 2012 insulin degludec was approved in Japan.
Insulin degludec marketed globally under the name Tresiba.