Investigational 2.0 mg dose of Ozempic® (semaglutide) demonstrates
superior reductions in blood sugar vs Ozempic® 1.0 mg in adults
with type 2 diabetes in a phase 3 trial
Bagsværd,
Denmark, 26 June
2021 – Novo Nordisk today presented data showing
that an investigational 2.0 mg dose of Ozempic® (semaglutide)
provided statistically significant and superior reductions in blood
sugar (HbA1C) compared with Ozempic® 1.0 mg1. These data were the
outcome of the SUSTAIN FORTE trial, a phase 3b, 40-week, efficacy
and safety trial comparing once-weekly semaglutide 2.0 mg vs
Ozempic® 1.0 mg as add-on to metformin with or without
sulfonylureas in 961 adults with type 2 diabetes in need of
additional blood sugar reduction. The results were presented at the
81st Annual Scientific Sessions of the American Diabetes
Association (ADA)1, 2 and primary results are in press for
publication in The Lancet Diabetes & Endocrinology.
The trial met its primary endpoint, where people treated with
once-weekly semaglutide 2.0 mg with an elevated mean baseline HbA1C
of 8.9% demonstrated a statistically significant and superior 2.2%
reduction in HbA1C compared with a reduction of 1.9% seen with
Ozempic® 1.0 mg after 40 weeks, when taken as intended*1.
Further post-hoc subgroup analyses, presented at the congress,
showed that semaglutide 2.0 mg demonstrated greater reductions
in blood sugar at 40 weeks compared with Ozempic® 1.0 mg, across
baseline HbA1C subgroups (Table 1) 2.
”Some people living with type 2 diabetes require additional
support to reach their blood glucose targets,” said Dr Juan Pablo
Frias, medical director of the National Research Institute, Los
Angeles, and principal investigator of SUSTAIN FORTE. “The
reductions in blood glucose seen with semaglutide 2.0 mg
demonstrate that a higher dose of Ozempic® may offer individuals
the opportunity to further improve their diabetes control, with
comparable tolerability to Ozempic® 1.0 mg."
From a mean baseline body weight of 99.3 kg, semaglutide 2.0 mg
demonstrated a statistically significant weight reduction of 6.9 kg
compared with 6.0 kg with Ozempic 1.0 kg®*. Further post-hoc
analyses presented across baseline BMI subgroups showed greater
non-significant reductions in body weight with semaglutide 2.0 mg
compared with the 1.0 mg dose (Table 1).
The incidence of adverse events (AEs) was similar for both doses
in the primary analysis and included gastrointestinal events
(nausea, diarrhoea and vomiting) across baseline HbA1C and BMI
subgroups1,2. This is consistent with AEs seen across the GLP-1 RA
class.
“Ozempic® has helped millions of people with type 2 diabetes
worldwide lower their blood sugar, reduce their risk of major
cardiovascular events in adults with established cardiovascular
disease and has demonstrated weight reduction for some patients,”
said Martin Lange, executive vice president of Novo Nordisk. “For
almost a century, our mission has been to drive change in diabetes
treatment and innovation to improve the lives of people living with
diabetes. These data show us that with a higher 2.0 mg dose of
semaglutide, we can help even more adults living with type 2
diabetes, who are not at glycaemic control, lower their HbA1c.”
|
Post-hoc
subgroup
analysis of
primary
endpoint:
Change in
HbA1C2 |
Post-hoc
subgroup
analysis of
secondary
endpoint:Change
in body weight2 |
Baseline |
HbA1C <9.0% |
HbA1C ≥9.0% |
BMI <35 |
BMI ≥35 |
HbA1C <9.0% |
HbA1C ≥9.0% |
BMI <35 |
BMI ≥35 |
Semaglutide 2.0 mg |
-1.9% |
-2.6% |
-2.2% |
-2.1% |
-7.4 kg |
-6.3 kg |
-6.6 kg |
-7.4 kg |
Ozempic® 1.0 mg |
-1.7% |
-2.3% |
-1.9% |
-2.0% |
-6.2 kg |
-5.8 kg |
-5.2 kg |
-7.1 kg |
Table 1. Post-hoc subgroup analysis showing change in mean HbA1C
and body weight stratified from baseline to Week 40**.
On the basis of the primary results, Novo Nordisk previously
announced submission of a label extension application to the
European Medicines Agency (EMA) in December 2020, and to the US
Food and Drug Administration (FDA) in May 2021, to evaluate an
additional higher dose of 2.0 mg Ozempic® for adults with type 2
diabetes.
For more news and media materials from Novo Nordisk at ADA 2021,
please visit: https://novonordiskada2021.mediahub.cplus.live/
About Ozempic®Ozempic®
(semaglutide) injection 0.5 mg or 1.0 mg is a once-weekly
glucagon-like peptide-1 (GLP-1) receptor agonist indicated along
with diet and exercise to improve blood sugar (glucose) in adults
with type 2 diabetes mellitus3, 4 and to reduce the risk of major
cardiovascular events such as heart attack, stroke, or death in
adults with type 2 diabetes mellitus with known heart disease4.
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.
About Novo NordiskNovo 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
45,800 people in 80 countries and markets its products in around
170 countries. For more information, visit novonordisk.com,
Facebook, Twitter, LinkedIn, YouTube.
Further information
Media: |
|
|
Mette Kruse
Danielsen |
+45 3079 3883 |
mkd@novonordisk.com |
Michael Bachner
(US) |
+1 609 664
7308 |
mzyb@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 |
Mark Joseph Root
(US) |
+1 848 213
3219 |
mjhr@novonordisk.com |
_______________________References1. Frias
J, Auerbach P, Bajaj H, et al. Efficacy and Safety of Once-Weekly
Semaglutide 2.0 vs 1.0 mg for Type 2 Diabetes: SUSTAIN FORTE
Randomized Trial. Presented during the 81st Scientific Sessions of
the American Diabetes Association: Oral
101-OR.2. Frias J, Auerbach P,
Bajaj H, et al. Efficacy and Safety of Once-Weekly Semaglutide 2.0
vs 1.0 mg by Baseline HBA1c and BMI: SUSTAIN FORTE Subgroup
Analyses. Presented during the 81st Scientific Sessions of the
American Diabetes Association: ePoster
665-P.3. EMA. Ozempic®
(once-weekly semaglutide) Summary of Product Characteristics.
Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004174/WC500244163.pdf.
Last accessed: June 2021.4. FDA.
Ozempic® (once-weekly semaglutide) US Prescribing Information.
Available at: https://www.novo-pi.com/ozempic.pdf Last accessed:
June 2021.
*Based on the trial product estimand: treatment effect if all
people adhered to treatment and did not initiate other type 2
diabetes therapies. When applying the treatment policy estimand,
which is the treatment effect regardless of treatment adherence or
initiation of other type 2 diabetes therapies, people treated with
semaglutide 2.0 mg experienced a reduction in HbA1C of 2.1%
compared to 1.9% for people treated with the 1.0 mg dose at Week
40.
*Based on the trial product estimand: treatment effect if all
people adhered to treatment and did not initiate other type 2
diabetes therapies. Based on the treatment policy estimand, people
treated with semaglutide 2.0 mg experienced a statistically
non-significant weight reduction of 6.4 kg compared with 5.6 kg
with Ozempic® 1.0 mg. Treatment policy estimand: treatment effect
regardless of treatment adherence or initiation of other type 2
diabetes therapies.
**Treatment-by-treatment subgroup interactions were
non-significant. Data are estimated mean values and represent all
randomised participants who had not discontinued treatment or
initiated additional antidiabetic medications.
- PR210626_SUSTAIN_FORTE_ ADA_protected
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