Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
09 January 2024 - 12:38AM
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
January 8, 2024
________________
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 [ ] |
COMBINE
3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily
basal-bolus treatment (insulin glargine U100 and insulin aspart) in people with type 2 diabetes
Bagsværd, Denmark, 8 January 2024 – Novo Nordisk today announced topline results
from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. COMBINE
3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly IcoSema vs once-daily insulin glargine
U100 and insulin aspart (injected 2-4 times a day during mealtimes), dosed with or without oral glucose-lowering medications, in 679
people with type 2 diabetes inadequately controlled on daily basal insulin.
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c
at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart.
From an overall baseline HbA1c of 8.30%, once-weekly IcoSema achieved an estimated
reduction in HbA1c of -1.47 percentage points compared with -1.40 percentage points for insulin glargine U100 and insulin
aspart (estimated treatment difference: –0.06 percentage points). Further, from a baseline body weight of 85.8 kg, people treated
with IcoSema achieved a superior reduction in estimated change of body weight a weight loss of -3.6 kg with IcoSema and a weight gain
of 3.2 kg with insulin glargine U100 and insulin aspart (estimated treatment difference: -6.7 kg).
In the trial, IcoSema was superior to insulin glargine U100 and insulin aspart in estimated rates of severe or clinically significant
(blood glucose below 3.0 mmol/L) hypoglycaemia, with 0.26 events per patient-year of exposure for once-weekly IcoSema and 2.18 events
per patient-year of exposure for insulin glargine U100 and insulin aspart. In the trial, once-weekly IcoSema appeared to have a safe
and well-tolerated profile. The most common adverse events for people treated with IcoSema were gastrointestinal consistent with GLP-1
receptor agonist class and the vast majority were mild to moderate.
Page
2 of 3
“We are very pleased to share the first phase 3a results for once-weekly IcoSema”, said Martin Holst Lange, executive vice
president for Development at Novo Nordisk. “The results demonstrate the potential of IcoSema to simplify insulin intensification
by reducing the injection burden to a single injection per week compared to around 28 injections per week for people with type 2 diabetes
inadequately controlled on basal insulin while providing glycaemic control as well as weight benefits and lower rates of hypoglycaemia.”
COMBINE 3 is the first trial to readout in the phase 3a COMBINE programme, and results from COMBINE 1 and COMBINE 2 will be shared later
this year.
About once-weekly IcoSema
Once-weekly IcoSema is fixed-ratio combination of a once-weekly basal insulin icodec and onceweekly semaglutide
(700U/2 mg per millilitre). IcoSema is titrated in the same way as insulin, with a maximum weekly dose of 350 dose steps (ie 350 U insulin
icodec/1mg semaglutide).
About the COMBINE clinical development programme
Once-weekly IcoSema is being evaluated in the phase 3a COMBINE programme, which consists
of three, multinational, multicentre, randomised, parallel-group, open-label, treat-to target trials.
COMBINE 1 is a 52-week trial comparing once-weekly IcoSema with insulin icodec. The objective of the trial is to assess the efficacy and
safety of IcoSema in around 1.300 people with type 2 diabetes inadequately controlled on basal insulin treatment. The trial was initiated
in the second quarter of 2022.
COMBINE 2 is a 52-week trial comparing once-weekly IcoSema with semaglutide 1.0 mg. The objective of the
trial is to assess the efficacy and safety of IcoSema in around 700 people with type 2 diabetes inadequately controlled on GLP-1 treatment.
The trial was initiated in the second quarter of 2022.
COMBINE 3 was a 52-week trial comparing once-weekly IcoSema with once-daily basal
insulin glargine U100 and insulin aspart (injected 2-4 times a day during mealtimes) in 679 people with type 2 diabetes inadequately controlled
on basal insulin treatment.
Page 3 of 3
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 serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering
scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs
about 61,400 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, Instagram,
X, LinkedIn and YouTube.
Contacts for further information
Media: |
|
Ambre James-Brown
+45 3079 9289
abmo@novonordisk.com |
Elizabeth DeLuca (US)
+1 609 580 9868
edel@novonordisk.com |
|
|
Investors: |
|
Daniel Muusmann Bohsen
+45 3075 2175
dabo@novonordisk.com |
Jacob Martin Wiborg Rode
+45 3075 5956
jrde@novonordisk.com |
|
|
David Heiberg Landsted
+45 3077 6915
dhel@novonordisk.com |
Mark Joseph Root (US)
+1 848 213 3219
mjhr@novonordisk.com |
|
|
Sina Meyer
+45 3075 6656
azey@novonordisk.com |
Frederik Taylor Pitter
+45 3075 8259
fptr@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 02 / 2024 |
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: January 8, 2024 |
NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer |
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