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
08 Januar 2024 - 1:49PM
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
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.
“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 IcoSemaOnce-weekly IcoSema is
fixed-ratio combination of a once-weekly basal insulin icodec and
once-weekly 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
programmeOnce-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.
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 9289abmo@novonordisk.com |
Elizabeth
DeLuca (US)+1 609 580 9868edel@novonordisk.com |
Investors: |
|
Daniel
Muusmann Bohsen+45 3075 2175 dabo@novonordisk.com |
Jacob
Martin Wiborg Rode+45 3075 5956jrde@novonordisk.com |
David
Heiberg Landsted +45 3077 6915 dhel@novonordisk.com |
Mark
Joseph Root (US) +1 848 213 3219mjhr@novonordisk.com |
Sina
Meyer +45 3079 6656azey@novonordisk.com |
Frederik
Taylor Pitter +45 3075 8259fptr@novonordisk.com |
Company announcement No 2 / 2024
- PR240108 -IcoSema-COMBINE-3
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