Data Show That the Combination of Insulin Degludec/Insulin Aspart Significantly Reduced Hypoglycaemia in Type 1 and Type 2 Diabetes Patients

DUBAI, United Arab Emirates--(BUSINESS WIRE)--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 2 diabetes compared to biphasic insulin aspart 30 (BIAsp 30) when dosed twice-daily. This is according to a study released today by Novo Nordisk at the International Diabetes Federation (IDF) 21^st World Diabetes Congress.¹

“These benefits, along with the lower risk of hypoglycaemia and improved FPG shown in these studies, are very promising for people living with type 2 diabetes.”

In this phase 2 study, 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%) .¹

“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 2 diabetes.”

In addition, a phase 3 study also presented today, showed that rates of hypoglycaemia at night were lowered by 37%^*** in people with type 1 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.²

Insulin degludec/insulin aspart, in development by Novo Nordisk, will, pending approval, 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.³

Insulin degludec has a unique, slow rate of absorption which provides a flat and stable action profile.^4,5 In several clinical trials, insulin degludec has demonstrated effective glycaemic control and improvements in both HbA_1c and FPG.^6-9 It has also demonstrated a significantly lower rate of nocturnal hypoglycaemia when compared to insulin glargine.^6,8

Both insulin degludec and insulin degludec/insulin aspart were submitted to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) earlier this year for regulatory review.

Ends

Editors notes

^* Estimated rate ratio (ERR): 0.42 [0.23; 0.75]
^** Estimated treatment difference (ETD):-0.99mmol/l [-1.68; -0.29])
^*** ERR: 0.63 [95% CI: 0.49; 0.81] p=0.0003

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 88 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.co.uk.

References:
1. Niskanen et al. IDegAsp, a soluble insulin combination of ultra-long-acting insulin degludec and insulin aspart, in type 2 diabetes: comparison with biphasic insulin aspart 30. NN data on file (1792) IDF abstract #P-1437

2. Hirsch et al. BOOST™ T1 IDegAsp, a soluble insulin combination of ultra-long-acting insulin degludec and insulin aspart, used once daily in basal-bolus treatment with insulin aspart in type 1 diabetes . NN data on file (3594) IDF abstract #P-1438

3. Vaag A et al. IDEGASP, a soluble insulin combination of ultra-long-acting insulin Degludec and insulin aspart, in type 2 diabetes: comparison with biphasic insulin aspart 30. Poster 1040, presented at European Association for the Studies of Diabetes (EASD), Lisbon, September, 2011

4. Heise T, et al. Insulin Degludec: two fold longer half-life and a more consistent pharmacokinetic profile compared to insulin glargine. NN data on file (1993) IDF abstract #P-1444

5. Kurtzhals P, et al. Multi-hexamer formation is the underlying basis for the ultra-long glucose lowering effect of insulin degludec. Poster 1049, presented at European Association for the Studies of Diabetes (EASD), Lisbon, September, 2011

6. Garber A et al. Insulin degludec improves long-term glycaemic control with a lower rate of hypoglycaemia vs. insulin glargine in type 2 diabetes. NN data on file (3582) IDF abstract #P-1442

7. Heller S, et al. Induced hypoglycaemia in type 1 diabetes: enhanced counter-regulatory hormone response with insulin Degludec versus insulin glargine. NN data on file (3538) IDF abstract #D-0723

8. Home PD, et al. Poster 941, presented at European Association for the Studies of Diabetes (EASD), Lisbon, September, 2011

9. Atkin SL, et al. Oral Presentation, abstract 112, presented at European Association for the Studies of Diabetes (EASD), Lisbon, September, 2011