Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
November 18 2020 - 06:06AM
Edgar (US Regulatory)
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
November 17, 2020
________________
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-________
Once-weekly semaglutide 2.0 mg
demonstrates superior reduction in HbA1c vs once-weekly
semaglutide 1.0 mg in people with type 2 diabetes in the SUSTAIN
FORTE trial
Bagsværd, Denmark,
17 November 2020 - Novo Nordisk today announced headline
results from the SUSTAIN FORTE trial, a phase 3b 40-week, efficacy
and safety trial with once-weekly semaglutide 2.0 mg vs once-weekly
semaglutide 1.0 mg as add-on to metformin and/or sulfonylureas in
961 people with type 2 diabetes in need for treatment
intensification. The trial achieved its primary endpoint by
demonstrating a statistically significant and superior reduction in
HbA1c at week 40
with semaglutide 2.0 mg compared to semaglutide 1.0 mg.
When evaluating the effects of treatment taken as
intended1 and
from a high
mean baseline HbA1c
of 8.9%, people treated with semaglutide 2.0 mg achieved a
statistically significant and superior reduction in HbA1c of 2.2% compared with a
reduction of 1.9% with semaglutide 1.0 mg at week 40. The American
Diabetes Association (ADA) treatment target of HbA1c below 7.0% was achieved by
68% of people treated with semaglutide 2.0 mg vs 58% on semaglutide
1.0 mg.
From a mean baseline body weight of 99.3 kg, people treated with
semaglutide 2.0 mg experienced a statistically
significant1 and
superior weight loss of 6.9 kg compared with 6.0 kg with
semaglutide 1.0 mg.
When applying the treatment policy estimand2, people treated with
semaglutide 2.0 mg experienced a reduction in HbA1c of 2.1% compared to 1.9% for
people treated with 1.0 mg dose at week 40. People treated with
semaglutide 2.0 mg experienced a statistically non-significant
weight loss of 6.4 kg compared with 5.6 kg with semaglutide 1.0
mg.
______________________________
1 Based on the trial
product estimand: treatment effect if all people adhered to
treatment and did not initiate other type 2 diabetes
therapies
2 Based on the treatment
policy estimand: treatment effect regardless of treatment adherence
or initiation of other type 2 diabetes therapies
Page 2 of 3
|
Trial
product estimand1 |
Treatment
policy estimand2 |
Once-weekly semaglutide |
2.0 mg |
1.0 mg |
2.0 mg |
1.0 mg |
HbA1c
reduction |
2.2%* |
1.9% |
2.1%* |
1.9% |
Body weight reduction |
6.9 kg* |
6.0 kg |
6.4 kg |
5.6 kg |
*Statistically significant vs once-weekly semaglutide 1.0 mg
In the trial, both doses of semaglutide appeared safe and
well-tolerated. The most common adverse events were
gastrointestinal, the vast majority were mild to moderate and
diminished over time and were consistent with the GLP-1 receptor
agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal
adverse events were similar for semaglutide 2.0 mg with nausea
rates around 15% for both doses. The treatment discontinuation
rates due to adverse events were similar and below 5% for both
doses of semaglutide.
“We are very pleased with the results from the SUSTAIN FORTE trial
with the large HbA1c reduction from a high
baseline as well as the safety and tolerability profile, which
establish a attractive benefit-risk ratio for treatment of type 2
diabetes with semaglutide” said Mads Krogsgaard Thomsen, executive
vice president and chief scientific officer of Novo Nordisk.
“Semaglutide 1.0 mg has across the SUSTAIN programme demonstrated
that up to 80% of patients achieved HbA1c levels below 7%. This study
demonstrates that patients in poor glycaemic control increase the
likelihood of achieving their HbA1c target when treated with
semaglutide 2.0 mg.”
About the SUSTAIN clinical programme
The SUSTAIN clinical development programme for once-weekly
subcutaneous semaglutide injection currently comprises 11 phase 3
global clinical trials, including a cardiovascular outcomes trial,
involving more than 11,000 adults with type 2 diabetes in total.
Semaglutide 1.0 mg is approved under the brand name
Ozempic® indicated for type 2
diabetes.
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 44,000 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,
YouTube.
Page 3 of 3
Further information
Media: |
|
|
Mette Kruse Danielsen |
+45
3079 8883 |
mkd@novonordisk.com |
Ken Inchausti (US) |
+1 609
240 9429 |
kiau@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann
Bohsen |
+45
3075 2175 |
dabo@novonordisk.com |
Valdemar Borum
Svarrer |
+45
3079 0301 |
jvls@novonordisk.com |
Ann Søndermølle
Rendbæk |
+45
3075 2253 |
arnd@novonordisk.com |
Mark Joseph Root |
+45
3079 4211 |
mjhr@novonordisk.com |
Kristoffer Due Berg
(US) |
+1 609
235 2989 |
krdb@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
|
|
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Company announcement No 71 / 2020 |
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: November
17, 2020 |
NOVO
NORDISK A/S
Lars Fruergaard Jørgensen
Chief
Executive Officer
|