New data show long-term efficacy and safety of Tresiba® in children and adolescents with type 1 diabetes

Vienna, Austria, 16 September - Today, at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD), Novo Nordisk announced new data from the BEGIN® YOUNG 1 trial. The study investigates once-daily Tresiba® (insulin degludec) versus insulin detemir, both in combination with bolus insulin aspart in a 52-week trial in children and adolescents with type 1 diabetes. This trial is the first to look into the long-term safety of Tresiba® in children and adolescents (from age 1 to less than 18 years). The results show that Tresiba® in combination with insulin aspart effectively improved long-term glycaemic control1.

"When treating children and adolescents with type 1 diabetes, it is critical that the right balance between glycaemic control and side effect management is maintained to ensure the best possible long-term outcomes. These data show that Tresiba®has the potential to offer youngsters with diabetes a new treatment option, which may help them achieve better control of their diabetes," said Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, United Kingdom.

The BEGIN® YOUNG 1 trial was a randomised controlled, 26 week open-label, treat-to-target trial (with a 26-week extension) investigating the efficacy and safety of Tresiba®, given once daily, and insulin detemir, given once or twice daily, both in combination with bolus insulin aspart in children and adolescents with type 1 diabetes.

Tresiba® met the primary endpoint of non-inferiority to insulin detemir for mean change in HbA1c (p<0.05) at 26 weeks. In the 26-week extension a lower insulin dose and a significantly greater reduction in fasting plasma glucose (FPG*) versus insulin detemir (p<0.05) was achieved1. Both regimens had similar rates of overall and nocturnal hypoglycaemia, the rate of severe hypoglycaemia was numerically higher with insulin degludec plus insulin aspart1. Of note, patients on Tresiba® had significantly lower rates of hyperglycaemia with ketosis (p<0.05)1. Weight (measured as SD score[**]) increased with Tresiba® and remained unchanged with insulin detemir1. Adverse event profiles were similar for insulin degludec and insulin detemir1.

About Tresiba® Tresiba® (insulin degludec) is a once-daily basal insulin that provides an ultra-long duration of action beyond 42 hours2,3. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment.  On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time3-5.

Tresiba® has received regulatory approval in Argentina, Aruba, Bangladesh, Bosnia & Herzegovina, Brazil, Chile, Colombia, Costa Rica, El Salvador, the EU, Honduras, Hong Kong, Iceland, Israel, India, Japan, Kazakhstan, Lichtenstein, Lebanon, Macedonia, Mexico, Nepal, Norway, South Korea, Switzerland and Russia.

 

Further information:

MediaKatrine Sperling +45 4442 6718 [email protected]
Investors:    
Kasper Roseeuw Poulsen +45 3079 4303 [email protected]
Jannick Lindegaard Denholt +45 3079 8519 [email protected]
Daniel Bohsen +45 3079 6376 [email protected]
Frank Daniel Mersebach (US) +1 609 235 8567 [email protected]

References

  1. Thalange N,et al. Long-term efficacy and safety of insulin degludec in combination with bolus insulin aspart in children and adolescents with type 1 diabetes. Poster presented at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD), Vienna, Austria, 15-19 September 2014.
  2. Kurtzhals P, et al.Multi-hexamer formation is the underlying mechanism behind the ultra-long glucose-lowering effect of insulin degludec.Diabetes. 2011;60(Suppl 1):LB12 (Abstract 42-LB).
  3. Tresiba® Summary of Product Characteristics. Bagsværd, Denmark, Novo Nordisk A/S; 2014.
    1. Meneghini L,et al.The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily.Diabetes Care. 2013;36:858-64.
  4. Mathieu C,et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension.J Clin Endocrinol Metab. 2013;98:1154-62.

 

* FPG measures the concentration of glucose in the plasma after the patient has not eaten for at least eight hours.

[**] Standard deviation (SD) measures the amount of variation from the average. A low standard deviation indicates that the data points are close to the average; a high standard deviation indicates that the data points are spread out over a large range of values.

 

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