6-K 1 f6k_053017.htm FORM 6-K



Washington, D.C. 20549









Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934


May 27, 2017




 (Exact name of Registrant as specified in its charter)



Novo Allé 

DK- 2880, Bagsvaerd 


(Address of principal executive offices)



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If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-________







Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba® label


Bagsværd, Denmark, 27 May 2017 – Novo Nordisk today announced the submission of a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba® (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba® compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.


In the DEVOTE trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba® compared to insulin glargine U100. The trial thereby confirmed the results of the DEVOTE interim analysis submitted to the FDA in March 2015, on the basis of which Tresiba® and Ryzodeg® 70/30 were approved in the US in September 2015.


The primary endpoint of the DEVOTE study was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non- fatal stroke and showed a hazard ratio of 0.91 in favour of Tresiba® relative to insulin glargine U100, with no statistically significant difference between the two treatments.


From a mean HbA1c baseline of 8.4%, the trial showed a similar reduction with Tresiba® compared to insulin glargine U100 with an end-of-trial treatment difference of 0.01 percentage points between the two treatment arms, thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments.


In the trial, Tresiba® demonstrated superiority on the secondary confirmatory endpoint of severe hypoglycaemia: 27% fewer patients in the Tresiba® treated group experienced an episode of severe hypoglycaemia, resulting in a 40% overall rate reduction of total episodes of adjudicated severe hypoglycaemia. Furthermore, patients in the Tresiba® treated group experienced a 54% relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant.


Tresiba® appeared to have a safe and well-tolerated profile consistent with previous clinical studies conducted with Tresiba®.



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“The risk of severe hypoglycaemia is a major cause for people with type 2 diabetes not reaching their treatment targets,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “However, with the DEVOTE data, we have demonstrated that the strong clinical profile of Tresiba® leads to a significant reduction in severe hypoglycaemia in people with type 2 diabetes.”



DEVOTE is a long-term, multi-centre, multi-national, randomised, double-blinded, parallel group and event-driven trial conducted to confirm the cardiovascular safety of Tresiba® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people with type 2 diabetes at high risk of cardiovascular disease were randomised to treatment with either Tresiba® or insulin glargine U100 in vial in addition to standard of care.


The DEVOTE trial has been conducted in response to a Complete Response Letter received from the FDA in February 2013 requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications for Tresiba® and Ryzodeg® 70/30 could be concluded. Tresiba® and Ryzodeg® 70/30 were approved in the US in September 2015 on the basis of an interim analysis of DEVOTE.


About Tresiba®

Tresiba® (insulin degludec) is a once-daily basal insulin that provides duration of action of at least 42 hours. Tresiba® is taken once daily, at any time of day. Patients who miss or are delayed in taking their dose of Tresiba® can take their dose as soon as they remember, but ensuring there are at least eight hours between doses. Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It was approved by the US FDA in September 2015.



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 42,000 people in 77 countries and markets its products in more than 165 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, Facebook, Twitter, LinkedIn, YouTube



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Further information


Katrine Sperling +45 4442 6718 krsp@novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Hanna Ögren +45 3079 8519 haoe@novonordisk.com
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com







Novo Nordisk A/S

Investor Relations

Novo Allé

2880 Bagsværd



+45 4444 8888


CVR no:

24 25 67 90

    Company announcement No 39 / 2017





Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.


Date: May 30, 2017




Lars Fruergaard Jørgensen

Chief Executive Officer