UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
June 3, 2022
________________
NOVO NORDISK A/S
(Exact name
of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F
Form 20-F [X] |
Form 40-F [ ] |
Indicate by check mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
If “Yes” is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g-32(b):82-________
Novo
Nordisk achieves primary objectives of ONWARDS 1 and 6 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c
vs insulin glargine U100 in ONWARDS 1
Bagsværd, Denmark, 3
June 2022 – Novo Nordisk today announced headline results from the main phases of ONWARDS 1 (52 weeks) and ONWARDS 6 (26 weeks)
phase 3a trials with once- weekly insulin icodec.
ONWARDS 1 (insulin naïve people with type 2 diabetes)
ONWARDS 1 is a phase 3a, 78-week efficacy and safety treat-to-target
trial investigating once- weekly insulin icodec vs insulin glargine U100 (insulin glargine), both in combination with non- insulin anti-diabetic
treatment, in 984 insulin-naïve people with type 2 diabetes.
The trial achieved its primary
endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared
to insulin glargine.
From an overall baseline HbA1c
of 8.5% once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of -1.55% compared
to -1.35% for insulin glargine (estimated treatment difference: -0.19%). Superior time in range (TIR) was also achieved for once-weekly
insulin icodec compared to insulin glargine.
In the trial, there was no statistically significant difference
in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3mmol/L) with 0.30 events per patient year exposed
to once-weekly insulin icodec and 0.16 events per patient-year exposed to insulin glargine. In the trial, once-weekly insulin icodec appeared
to have a safe and well-tolerated profile.
ONWARDS 6 (basal-bolus treatment in people with type
1 diabetes)
ONWARDS 6 is a phase 3a, 52-week efficacy and safety treat-to-target
trial investigating once- weekly insulin icodec vs insulin degludec, both in combination with three daily mealtime insulin injections,
in 582 people with type 1 diabetes.
The trial achieved its primary endpoint of demonstrating
non-inferiority in reducing HbA1c at week 26 with insulin icodec compared to insulin degludec.
From an overall baseline HbA1c
of 7.6%, once-weekly insulin icodec achieved a reduction in estimated HbA1c of -0.47% compared to
-0.51% for insulin degludec (estimated treatment difference: 0.05%).
In the trial, there was a statistically significant higher
estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed
to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. In the trial, once-weekly insulin icodec
appeared to have a safe and well-tolerated profile.
“The results
of the main phase of ONWARDS 1 confirm the strong results seen in ONWARDS 2 and strengthen the profile of once-weekly insulin icodec which
has the potential to become the ideal insulin for people with type 2 diabetes initiating insulin treatment”, says Martin Holst Lange,
executive vice president for Development at Novo Nordisk. “The results of the main phase of ONWARDS 6 reflect the complexity of
introducing a once-weekly insulin in basal bolus treatment for people with type 1 diabetes. Novo Nordisk remains confident that once-weekly
insulin icodec holds the potential to become a safe and efficacious treatment in type 1 diabetes.”
About the ONWARDS clinical programme
The ONWARDS clinical development programme for once-weekly
insulin icodec currently comprises six phase 3a global clinical trials, including a trial with real-world elements, involving more than
4,000 adults with type 1 or type 2 diabetes.
ONWARDS 1 is a 78-week trial comparing the efficacy
and safety of once-weekly insulin icodec with once-daily insulin glargine U100 both in combination with non-insulin anti-diabetic treatment
in 984 insulin-naïve people with type 2 diabetes. Following the completion of the main phase of the trial, a 26-week extension phase
is ongoing.
ONWARDS 2 was a phase 3a, 26-week efficacy and safety
treat-to-target trial investigating once- weekly insulin icodec vs insulin degludec in 526 people with type 2 diabetes switching from
a once-daily insulin. The results were reported on 28 April 2022.
ONWARDS 3 is a 26-week trial comparing once-weekly
insulin icodec with once-daily insulin degludec. The objective of the trial is to assess the efficacy and safety of insulin icodec in
588 insulin-naïve people with type 2 diabetes.
ONWARDS 4 is a 26-week trial comparing once-weekly insulin
icodec with once-daily insulin degludec, both in combination with mealtime insulin. The objective of the trial is to assess the efficacy
and safety of insulin icodec in 582 people with type 2 diabetes treated with basal and bolus insulin.
ONWARDS 5 is a 52-week trial comparing once-weekly
insulin icodec with once-daily basal insulin. The objective of the trial is to assess the effectiveness and safety of insulin icodec,
with an app providing dosing recommendation, in 1085 insulin-naïve people with type 2 diabetes in a clinical practice setting.
ONWARDS 6 is a 52-week trial comparing once-weekly insulin
icodec with once-daily insulin degludec, both in combination with mealtime insulin. The objective of the trial is to assess the efficacy
and safety of insulin icodec in 583 people with type 1 diabetes. Following the completion of the main phase of the trial, a 26-week extension
phase is ongoing.
About Novo Nordisk
Novo Nordisk is a leading
global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other
serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding
access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries
and markets its products in around 170 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 and YouTube
Further information
Media: |
|
|
Ambre Brown Morley |
+45 3079 9289 |
abmo@novonordisk.com |
Natalia Salomao Abrahao |
+1 848 304 1027 |
niaa@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann Bohsen |
+45 3075 2175 |
dabo@novonordisk.com |
Ann Søndermølle Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
David Heiberg Landsted |
+45 3077 6915 |
dhel@novonordisk.com |
Jacob Martin Wiborg Rode |
+45 3075 5956 |
jrde@novonordisk.com |
Mark Joseph Root (US) |
+1 848 213 3219 |
mjhr@novonordisk.com |
Novo Nordisk A/S
Investor Relations |
Novo Allé
2880 Bagsværd
Denmark |
Telephone:
+45 4444 8888 |
Internet:
www.novonordisk.com
CVR no:
24 25 67 90 |
|
|
Company announcement No 49 / 2022 |
SIGNATURES
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: June 3, 2022 |
NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer |
Novo Nordisk (PK) (USOTC:NONOF)
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