Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
November 18 2020 - 5:06AM
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
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Trial
product estimand1
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Treatment
policy estimand2
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Once-weekly semaglutide
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2.0 mg
|
1.0 mg
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2.0 mg
|
1.0 mg
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HbA1c
reduction
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2.2%*
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1.9%
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2.1%*
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1.9%
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Body weight reduction
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6.9 kg*
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6.0 kg
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6.4 kg
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5.6 kg
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*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:
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Mette Kruse Danielsen
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+45 3079 8883
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mkd@novonordisk.com
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Ken Inchausti (US)
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+1 609 240 9429
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kiau@novonordisk.com
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Investors:
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Daniel Muusmann Bohsen
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+45 3075 2175
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dabo@novonordisk.com
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Valdemar Borum Svarrer
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+45 3079 0301
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jvls@novonordisk.com
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Ann Søndermølle Rendbæk
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+45 3075 2253
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arnd@novonordisk.com
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Mark Joseph Root
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+45 3079 4211
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mjhr@novonordisk.com
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Kristoffer Due Berg (US)
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+1 609 235 2989
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krdb@novonordisk.com
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Novo Nordisk A/S
Investor Relations
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Novo Allé
2880 Bagsværd
Denmark
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Telephone:
+45 4444 8888
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Internet:
www.novonordisk.com
CVR no:
24 25 67 90
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Company announcement No 71 / 2020
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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
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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