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. A study demonstrated that changes in the injection time of insulin degludec from day to day (up to 40 hours apart) did not affect overall glycaemic control or risk of hypoglycaemia when compared to insulin glargine given at the same time each day. Data were presented today at the 47th meeting of the European Association for the Study of Diabetes (EASD) in Lisbon. The clinical investigation of insulin degludec is ongoing 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 new data demonstrates that with insulin degludec, glycaemic control can be maintained even if people unintentionally take their insulin at a different time of the day or delay a dose," said Professor Jiten Vora, Consultant Physician and Endocrinologist for the Royal Liverpool University Hospitals. "It is becoming increasingly more important for us to offer patients a treatment regimen that both fits into their lives but also allays their fears, the greatest of these being hypoglycaemia."
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 confirmed hypoglycaemia were 3.6 and 3.5 episodes/person/year for insulin degludec and insulin glargine respectively and rates of night-time confirmed hypoglycaemia (defined as episodes with plasma glucose (PG) <3.1 mmol/l occurring between 00:00-05:59) being 0.6 and 0.7 episodes/patient/year respectively.