Novo Nordisk

New Data Confirm Tresiba® U200 Delivers Significantly Lower Rates of Confirmed Hypoglycaemia Versus Insulin Glargine U100

Stockholm (ots/PRNewswire) - This material is intended for global medical media only.

For journalistic assessment and preparation before publication.

New data presented today at the 51st annual meeting of the European Association for the Study of Diabetes (EASD) show that patients with type 2 diabetes receiving the U200 formulation of Tresiba(R) (insulin degludec) experienced significantly lower rates of confirmed hypoglycaemia and significantly reduced mean fasting blood glucose compared to those receiving insulin glargine U1001. Tresiba(R) U200 is twice as concentrated as U100, allowing patients to inject up to 160 units in a single injection, rather than in two separate injections.

"These findings provide valuable insights to physicians treating patients with type 2 diabetes, many of whom require higher doses of insulin," commented Dr Mark Warren, lead study investigator. "The more concentrated formulation of Tresiba(R) also means fewer injections, which will be a welcome option for those patients who require higher than 80 units."

The 32-week, open-label, crossover, treat-to-target trial compared the safety, efficacy and patient-reported outcomes of Tresiba(R) U200 to insulin glargine U100 in patients who might benefit from a low-volume basal insulin. In the study, patients with type 2 diabetes also reported higher satisfaction with Tresiba(R) U200, highlighting an overall preference versus insulin glargine U100. Patients receiving the more concentrated formulation of Tresiba(R) also reported numerically lower cases of nocturnal hypoglycaemia and lower weight change and rated the delivery device FlexTouch(R) significantly better for function1.

After 16 weeks, the study demonstrated1:

- Tresiba(R) U200 delivered non-inferiority to insulin glargine with respect to
  change in patient blood glucose levels
- Significantly reduced mean fasting plasma glucose with Tresiba(R) U200 versus insulin
  glargine (-0.82 mmol/L vs -0.05 mmol/L, p<0.05)
- Significantly lower confirmed hypoglycaemia rate with Tresiba(R) U200 versus insulin
  glargine (estimated rate ratio [ERR]; 0.59, p<0.05)
- Tresiba(R) U200 delivered numerically lower nocturnal hypoglycaemia rate versus
  insulin glargine (ERR; 0.66)
- Lower mean weight change with Tresiba(R) U200 versus insulin glargine (0.42 kg vs
  1.04kg).
 

In addition, 32.1% of patients in the Tresiba(R) U200 arm and 35.2% in the insulin glargine arm reported adverse events. Of these, 2.9% and 2.8% respectively were serious adverse events requiring third party intervention.

About Tresiba(R)  

Tresiba(R) (insulin degludec) is a once-daily basal insulin that provides 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(R) allows for flexibility in day-to-day dosing time when needed2,4,5. Tresiba(R) U200 enables up to 160 units of insulin to be dosed in a single injection, allowing people with diabetes to administer the same amount of insulin in half the volume as they are able to with current U100 formulations. No dose conversion is needed when transferring a patient from U100 to U200.

Tresiba(R) received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally.

About Novo Nordisk 

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com [http://novonordisk.com] , Facebook [http://www.facebook.com/novonordisk], Twitter [http://www.twitter.com/novonordisk], LinkedIn [http://www.linkedin.com/company/novo-nordisk], YouTube [http://www.Youtube.com/novonordisk]  

References 

1) Warren M, et al. Efficacy, patient reported outcomes and safety of insulin
  degludec U200 compared with insulin glargine in patients with type 2 diabetes (T2D)
  requiring high-dose insulin. Presented at the 51st annual meeting of the European
  Association for the Study of Diabetes (EASD); Stockholm, Sweden, 14-18 September 2015.
2) Tresiba(R) Summary of Product Characteristics. Bagsværd, Denmark, Novo Nordisk A/S;
  June 2015.
3) Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and
  their clinical relevance. Clin Pharmacokinet. 2014;53:787-800.
4) 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.
5) 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.
 

Contact:

Media:
Katrine Sperling +45-4442-6718krsp@novonordisk.com
Asa Josefsson +45-3079-7708aajf@novonordisk.com


Investors:
Peter Hugreffe Ankersen +45-3075-9085phak@novonordisk.com
Daniel Bohsen +45-3079-6376dabo@novonordisk.com
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Frank Daniel Mersebach (US) +1-609-235-8567 fdni@novonordisk.com



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