Once-weekly semaglutide 2.0 mg demonstrates superior reduction in HbA1c vs once-weekly semaglutide 1.0 mg in people with type...
November 17 2020 - 9:24AM
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.
|
Trial product estimand[1] |
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 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
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.
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 |
Company announcement No 71 / 2020
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
Novo Nordisk (TG:NOVC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Novo Nordisk (TG:NOVC)
Historical Stock Chart
From Jul 2023 to Jul 2024