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Data show that the combination insulin degludec/insulin aspart significantly reduced hypoglycaemia in type 1 and type 2 diabetes patients (6 Dec 2011)

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Dubai, UAE – Insulin degludec / insulin aspart reduced rates of hypoglycaemia by 58%* in people with type 2 diabetes compared to biphasic insulin aspart when dosed twice-daily. This is according to a study released today by Novo Nordisk at the International Diabetes Federation (IDF) 21st World Diabetes Congress.1

In the study, insulin degludec/insulin aspart reduced the overall occurrence of hypoglycaemia during the day as well as at night (occurring between 23:00 and 05.59).  Improvements in fasting plasma glucose (FPG) were also seen, with levels significantly lower in the insulin degludec/insulin aspart group vs  biphasic insulin aspart (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.1

“The unique way in which insulin degludec/insulin aspart works, with the basal insulin 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 Global Chief Medical Officer, Novo Nordisk. “These benefits, along with the reduced risk of hypoglycaemia and improved FPG shown in these studies, are very promising for people living with diabetes.”

A second study also presented today showed that rates of hypoglycaemia at night were reduced by 37%*** in people with type 1 diabetes using once-daily insulin degludec/insulin aspart (with additional rapid-acting mealtime insulin doses for the remaining meals), compared to those using once-daily insulin detemir plus rapid-acting insulin at all main meals.2

____________________________________________

*     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

 

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 that it provides fasting plasma glucose control with significantly less hypoglycaemia compared to premix insulin.1

Insulin degludec has a unique, slow rate of absorption which provides a flat and stable action profile.3,4  In several clinical trials, insulin degludec has demonstrated effective glycaemic control and improvements in both HbA1c and FPG.5-7 It has also demonstrated a significantly lower rate of hypoglycaemia when compared to insulin glargine.5-9

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. 

 

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.com.

 


Further information:

Media:

Investors:

 

 

Katrine Sperling

Klaus Bülow Davidsen

Tel: (+45) 4442 6718

Tel: (+45) 4442 3176

krsp@novonordisk.com

klda@novonordisk.com

 

 

Ambre Morley

Frank Daniel Mersebach

Tel: (+1) 609 216 5240

Tel: (+45) 4442 0604

abmo@novonordisk.com

fdni@novonordisk.com

 

 

 

Lars Borup Jacobsen

 

Tel: (+45) 3075 3479

 

lbpj@novonordisk.com

 

 

 

Jannick Lindegaard

 

Tel: (+1) 609 786 4575

 

jlis@novonordisk.com


 

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. 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 . IDF abstract #P-1438

3.     Heise T, et al. Insulin Degludec: two fold longer half-life and a more consistent pharmacokinetic profile compared to insulin glargine. IDF abstract #P-1444

4.     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

5.     Hollander P et al. Insulin degludec improves long-term glycaemic control with a lower rate of hypoglycaemia vs. insulin glargine in type 2 diabetes. IDF abstract #P-1442

6.     Birkeland KI, et al. Insulin degludec: similar glycaemic control and safety when given in a flexible daily dosing regimen or the same time daily in type 2 diabetes. IDF abstract #P-1443

7.     Bain S, et al. Oral presentation: Flexible once-daily dosing of insulin degludec is as efficacious and safe as insulin glargine given the same time each day in type 2 diabetes. IDF abstract #O-0508

8.     Heller S, et al. Induced hypoglycaemia in type 1 diabetes: enhanced counter-regulatory hormone response with insulin Degludec versus insulin glargine. IDF abstract #D-0723

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

 

 

 

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