Media Contacts:

Katrine Sperling
Tel: (+45) 4442 6718
krsp@novonordisk.com

In North America:
Ken Inchausti
Tel: +1 609 514 8316
kiau@novonordisk.com

Ryzodeg® offers improved glycaemic control with significantly lower rates of hypoglycaemia compared to biphasic insulin aspart 30 in adults with type 2 diabetes1

COPENHAGEN, Denmark, 3 December, /PRNewswire/-– Data presented today at the World Diabetes Congress of the International Diabetes Federation (IDF) show that adults with type 2 diabetes achieved improved glycaemic control, significantly lower rates of overall and nocturnal confirmed hypoglycaemia for the full trial period, and a significantly lower rate of severe hypoglycaemia during the maintenance period (defined as week 16 onwards) with Ryzodeg® compared to biphasic insulin aspart 30, both administered twice-daily1.

Ryzodeg® is the first combination of two distinct insulin analogues, Tresiba® (insulin degludec), the once-daily basal insulin with an ultra-long duration of action, and the well-established mealtime insulin NovoRapid® (insulin aspart), in the ratio of 70% and 30%, in one pen for people with type 2 diabetes2-4.

“Type 2 diabetes is a progressive disease and many patients who are uncontrolled with basal insulin need to add mealtime insulin to achieve or maintain their glycaemic targets over time. As Ryzodeg® is a combination of two distinct insulins, a basal insulin with a long and steady action profile and a well-established mealtime insulin, it is a simple way for patients to add mealtime control with a reduced risk of overall and nocturnal confirmed, and severe hypoglycaemia,” said lead investigator Gregory Fulcher, Royal North Shore Hospital, Sydney, Australia.

The multinational BOOST™ INTENSIFY PREMIX I trial was a 26-week, randomised, controlled open-label, treat-to-target trial comparing the efficacy and safety of Ryzodeg® and biphasic insulin aspart 30, both administered twice-daily with or without oral antidiabetic drugs in adult patients with type 2 diabetes previously treated with premixed or self-mixed insulin either once- or twice-daily.

Overall study results include1:


About Ryzodeg®

Ryzodeg® is the global brand name for insulin degludec/insulin aspart. It is a combination of two distinct insulin analogues, Tresiba® (insulin degludec) and NovoRapid® (insulin aspart) in the ratio of 70% and 30%. Ryzodeg® delivered twice-daily at main meals offers successful reductions in HbA1c2 with lower rates of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2 diabetes5,6. Ryzodeg® has been approved in Japan, Mexico, EU, Norway, Iceland, Switzerland, El Salvador and Chile.

About the BOOST™ programme

Novo Nordisk completed the phase 3a BOOST™ programme in 2010. This programme consisted of six randomised, controlled, treat-to-target trials in more than 30 countries and comprised the majority of the data supporting the regulatory applications for Ryzodeg®. More than 2000 people were included in the development programme. The programme was designed after consultancy with regulatory agencies in Europe and USA.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 37,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com.

Further information

Media:
Katrine Sperling, +45 4442 6718, krsp@novonordisk.com
Ken Inchausti (US), +1 609 514 8316, kiau@novonordisk.com

Investors:
Kasper Roseeuw Poulsen, +45 4442 4303, krop@novonordisk.com
Frank Daniel Mersebach, +45 4442 0604, fdni@novonordisk.com
Daniel Bohsen, +45 3079 6376, dabo@novonordisk.com
Lars Borup Jacobsen, +45 3075 3479, lbpj@novonordisk.com
Jannick Lindegaard (US), +1 609 786 4575, jlis@novonordisk.com


References

  1. Fulcher G, et al. Insulin degludec/insulin aspart achieves superior FPG and less hypoglycaemia vs biphasic insulin aspart 30 in poorly controlled T2DM. Poster #1399, presented at International Diabetes Federation (IDF), World Diabetes Congress, Melbourne, December 2013.
  2. Ryzodeg® Summary of Product Characteristics (SmPC). May 2013.
  3. Jonassen I, et al. Ultra-long acting insulin degludec can be combined with rapid-acting insulin aspart in a soluble co-formulation. J Peptide Sci 2010;16(Suppl.1):32.
  4. De Rycke A, et al. Degludec – first of a new generation of insulins. Eur Endocrinol 2011;7:84-7.
  5. Fulcher G, et al. Superior FPG control and reduced hypoglycaemia with IDegAsp vs BIAsp 30 in adults with type 2 diabetes mellitus inadequately controlled on pre/self-mixed insulin: a randomised phase 3 trial. Diabetologia 2013;56(Suppl.1):S419-20 (abstract 1044).
  6. Vaag A, et al. Lower rates of overall, nocturnal and severe hypoglycaemia during maintenance treatment with IDegAsp vs biphasic insulin aspart 30 in patients with type 2 diabetes mellitus: a meta-analysis. Diabetologia 2013;56(Suppl.1):S83 (abstract 187).

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