Ultra-long-acting insulin degludec, an investigational basal insulin being developed by Novo Nordisk, showed significant blood sugar reductions in patients with type 2 diabetes even when doses were given once-daily up to 40 hours apart, according to data presented at the European Association for the Study of Diabetes (EASD) in Lisbon. Insulin degludec is still under clinical investigation and regulatory submission has not been filed.
The study showed that HbA1c, a standard measure of blood glucose, levels at 26-weeks was reduced by 1.28 percentage points to 7.2% with insulin degludec, comparable to insulin glargine. Additionally, fasting plasma glucose (FPG) reductions were significantly lower for insulin degludec (5.8mmol/l) at the end of the study than for insulin glargine (6.2mmol/l) (estimated treatment difference [EDT]: -0.42mmol/l [-0.82;-0.02] p < 0.05).
“This study demonstrates that 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,” said Professor Stephen Atkin, lead author of the study and Head of Academic Endocrinology, Diabetes and Metabolism, York Hull Medical School, UK. “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.”
Across safety parameters for this study, results for insulin degludec, dosed once daily, at varying times, either in the morning or evening, vs. insulin glargine, dosed once daily according to the label at the same time every day, were comparable. Overall rates of hypoglycaemia were 3.6 and 3.5 episodes/person/year for insulin degludec and insulin glargine respectively and rates of night-time hypoglycaemia (defined as episodes with plasma glucose (PG) <3.1 mmol/l occurring between 00:01-05:59) being 0.6 and 0.7 episodes/patient/year respectively.
In addition to these data, there were 12 posters for insulin degludec and an investigational combination, insulin degludec/insulin aspart, at EASD.
Estimated rate ratio (ERR): 1.03 [0.75;1.40], p = NS; ERR: 0.77 [0.44;1.35], p = NS
Insulin degludec is an ultra-long-acting basal insulin analogue under development by Novo Nordisk. It forms multi-hexamers upon subcutaneous injection, resulting in a soluble depot from which insulin degludec is slowly and continuously absorbed into the circulation, contributing to minimal blood glucose variations.
The pharmacodynamic profile of insulin degludec has been shown to have a low within-subject variability, which may contribute to the low risk of hypoglycaemia observed in clinical studies.