Novo confident on ultra-long acting insulin
pharmafile | December 8, 2011 | News story | Sales and Marketing | Novo Nordisk, diabetes, insulin
Novo Nordisk says a new combination of a long-acting insulin with a short-acting insulin helps patients maintain better control of their condition.
Insulin degludec is Novo Nordisk’s new ultra long-acting basal insulin analogue, and looks set to change treatment significantly.
Injected subcutaneously three-times a week, insulin degludec works for up to 40 hours, much longer than the 18-26 hours of current marketing leading long-acting insulins, Sanofi’s Lantus (insulin glargine) and Novo’s own Levemir (insulin detemir).
The new product was filed with the FDA and EMA in September, and Novo Nordisk believe it will one day overtake the current market leader, Sanofi’s Lantus, as the mainstay of insulin treatment.
Insulin degludec has been filed as a standalone basal insulin, and in a 2-in-1 co-formulation with bolus (short-acting) insulin aspart. New phase II and phase III data on this combination was announced at the International Diabetes Federation congress in Dubai.
A soluble co-formulation of insulin degludec and insulin aspart (IDegAsp) was associated with a 58% lower rate of confirmed hypoglycaemic episodes in people with type II diabetes compared to biphasic insulin aspart 30 (BIAsp 30) when dosed twice-daily.
The phase II study showed the overall occurrence of confirmed hypoglycaemia was lower with IDegAsp than with BIAsp 30 during the day as well as at night (nocturnal events, occurring between midnight and 06.00 am).
Improvements in fasting plasma glucose (FPG) were also seen, with levels significantly lower in the insulin degludec/insulin aspart group vs biphasic insulin aspart 30 (6.4 vs. 7.5 mmol/l). The study also found that insulin degludec/insulin aspart was well tolerated and provided comparable overall glycaemic control to biphasic insulin aspart (mean HbA1c at week 16: 6.7% vs. 6.7%).
Flexible timing
Novo Nordisk hope that regulators will allow insulin degludec to be used by patients at any meal. This would allow diabetes patients more flexibility, as current long-acting insulins have to be taken with a main meal.
“The unique way in which insulin degludec/insulin aspart works, with the basal insulin component providing an ultra-long and steady action profile, plus a bolus boost of insulin aspart, provides a simple way to introduce mealtime dosing at any meal,” said Dr Alan Moses, Corporate Vice President and Chief Medical Officer, Novo Nordisk.
“These benefits, along with the lower risk of hypoglycaemia and improved FPG shown in these studies, are very promising for people living with type II diabetes.”
A separate Phase III study showed that rates of hypoglycaemia at night were lowered by 37% in people with type I diabetes using once-daily insulin degludec/insulin aspart at any meal (with additional insulin aspart doses for the remaining meals), compared to those using insulin detemir once-daily plus insulin aspart at all main meals.
Insulin degludec/insulin aspart, if approved, would be the only soluble insulin combination of ultra-long-acting basal insulin degludec and rapid-acting insulin, insulin aspart. Clinical studies have shown it provides an optimal glycaemic control with significantly less nocturnal hypoglycaemia compared to premix insulin.
Insulin degludec has a unique, slow rate of absorption which provides a flat and stable action profile. In several clinical trials, insulin degludec has demonstrated effective glycaemic control and improvements in both HbA1c and FPG. It has also demonstrated a significantly lower rate of nocturnal hypoglycaemia when compared to insulin glargine.
Andrew McConaghie
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