Date: 2012-10-02
Type of information:
phase: 3
Announcement: presentation of results at the Annual Meeting of the European Association for the Study of Diabetes (EASD)
Company: Novo Nordisk (Denmark)
Product: insulin degludec
Action mechanism: Insulin degludec is an ultra-long-acting basal insulin analogue discovered and developed by Novo Nordisk. Insulin degludec has a distinct slow absorption which provides a flat and stable action profile.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: Novo Nordisk has announced that new data presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) show that patients with type 2 diabetes starting insulin therapy had a 43% lower rate of night-time hypoglycaemia* when using insulin degludec compared with those using insulin glargine (0.27 [insulin degludec] versus 0.46 [insulin glargine] episodes per patient per year, p<0.001) with equivalent improvements in glucose control.
In this 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 insulin glargine (both in combination with OADs), the rates of overall hypoglycaemia were similar between the two groups (1.72 [insulin degludec] versus 2.05 [insulin glargine] episodes per patient per year, p=NS). Furthermore, while the rates of severe hypoglycaemia were infrequent, they were significantly lower with insulin degludec compared with insulin glargine (0.01 [insulin degludec] versus 0.02 [insulin glargine] episodes per patient per year, p=0.02). This randomised, 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.
Lower rates of night-time hypoglycaemia with insulin degludec versus insulin glargine confirmed in a meta-analysis of phase 3a trials, also presented at EASD.
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 hypoglycaemia in adults with type 1 and type 2 diabetes, while obtaining equivalent improvements in glucose control, when compared with insulin glargine2.
Patients with type 2 diabetes who had not previously been treated with insulin showed the greatest reductions in night-time hypoglycaemia when using insulin degludec compared with insulin glargine:
· 36% (p<0.05) reduction in night-time hypoglycaemia with insulin degludec compared with insulin glargine (0.3, 0.2 and 0.8 episodes per patient per year with IDeg versus 0.4, 0.3 and 1.2 episodes per patient per year with IGlar for the trials 3579, 3672 and 3586 respectively) 2.
· 17% (p<0.05) reduction in overall hypoglycaemia with insulin degludec compared with insulin glargine (1.5, 1.2 and 3.0 episodes per patient per year with IDeg versus 1.8, 1.4 and 3.7 episodes per patient per year with IGlar for the trials 3579, 3672 and 3586 respectively) 2.
· 86% (p<0.05) reduction in the rates of severe hypoglycaemia with insulin degludec compared with insulin glargine (0.003, 0 and 0 episodes per patient per year with IDeg versus 0.02, 0 and 0.01 episodes per patient per year with IGlar for the trials 3579, 3672 and 3586 respectively)2.
Insulin degludec has been submitted for once-daily use to the EMA and the FDA in September 2011 for regulatory review (See http://biopharmanalyses.fr/product/?pageid=244). In addition, insulin degludec has been submitted for regulatory approval in a range of other countries. On 28 September 2012 insulin degludec was approved in Japan. Novo Nordisk expects to launch insulin degludec in Japan as soon as price negotiations have been successfully completed. At present, insulin degludec does not have marketing authorisation in other countries.
