Insulin degludec is a long-acting basal insulin analogue. Following subcutaneous injection, it forms multi-hexamers, which act as a soluble depot from which insulin degludec is slowly and continuously absorbed into the circulation.
"With insulin degludec, glycaemic control can be maintained even if people unintentionally delay a dose or take their insulin at a different time of the day," says Professor Stephen Atkin of York Hull Medical School.
The marketing applications are based on the results of the BEGIN and BOOST trial programmes, which evaluated Degludec and DegludecPlus in almost 10,000 patients with type I or type II diabetes. The trials showed that insulin degludec lowers blood glucose levels effectively, with a lower risk of hypoglycaemia than insulin glargine (Lantus).
In one trial, Professor Atkin and co-workers randomised people with type II diabetes to receive insulin degludec (n=229) or insulin glargine (n=230) once daily for 26 weeks. The timing of insulin degludec administration was alternated between morning and evening; insulin glargine was taken at the same time each day, in line with its licence.
Results showed that insulin degludec and insulin glargine produced similar reductions in HbA1c over 26 weeks (–1.28% vs –1.26%), at comparable daily doses and with no significant difference in rates of hypoglycaemia (3.6 vs 3.5 episodes per patient-year).
"This flexibility without compromising glucose control or the risk of hypoglycaemia is unprecedented, and suggests that insulin degludec could potentially offer a real advance in diabetes management for patients who are challenged to maintain exactly the same schedule from day to day," said Professor Atkin.
Novo Nordisk is also evaluating a fixed-ratio combination of insulin degludec with its GLP-1 analogue, liraglutide (Victoza).