Novo Nordisk announces presentation of data from key semaglutide clinical trials in diabetes, obesity and chronic kidney disease at the 84th Scientific Sessions of the American Diabetes Association
18 Junio 2024 - 7:00AM
Novo Nordisk announces presentation of data from key semaglutide
clinical trials in diabetes, obesity and chronic kidney disease at
the 84th Scientific Sessions of the American Diabetes Association
- FLOW kidney outcomes trial data evaluating efficacy and safety
of once-weekly semaglutide 1.0 mg in people with type 2
diabetes1
- SELECT cardiovascular outcomes trial data evaluating efficacy
and safety of once-weekly semaglutide 2.4 mg in people with obesity
and established cardiovascular disease, without diabetes2
- STEP HFpEF trial programme data evaluating efficacy and safety
of once-weekly semaglutide 2.4 mg in people with obesity-related
heart failure with preserved ejection fraction (HFpEF), with and
without diabetes3,4
Bagsværd, Denmark, 18 June 2024 – Novo Nordisk
today announced the presentation of 34 abstracts highlighting the
breadth of its portfolio at the upcoming 84th Scientific Sessions
of the American Diabetes Association (ADA). The conference will be
held in-person and virtually from 21–24 June 2024 in Orlando,
US.
Additional data from three landmark trials with semaglutide will
also be presented in dedicated scientific sessions. The trials
assess additional potential benefits of semaglutide, including
evaluation of kidney and cardiovascular endpoints in people with
type 2 diabetes and chronic kidney disease (FLOW, semaglutide 1.0
mg) and cardiovascular and glucose-related endpoints in people with
obesity and CVD, with and without diabetes (SELECT and STEP HFpEF,
semaglutide 2.4 mg).
“We recognise that cardiometabolic conditions like
cardiovascular disease, chronic kidney disease, obesity and type 2
diabetes are often interlinked and might occur in the same patient.
We need to develop medicines that address multiple facets of the
diseases,” said Stephen Gough, senior vice president and global
chief medical officer at Novo Nordisk. “The broad data being
presented this year at ADA reflect this goal. In particular, data
from FLOW and SELECT look at ways to treat common comorbidities of
diabetes and obesity, such as kidney disease and cardiovascular
disease.”
All abstracts will be published on the website of the journal
Diabetes®. Data from the scientific sessions will be made available
after their presentation.
Summary of presentationsScientific
sessionsThe following data will be presented in the
dedicated scientific sessions as a part of the scientific agenda of
the congress:
The first dedicated kidney outcome trial with a GLP1-RA once-weekly
semaglutide – FLOW trial results (scientific session; 24 June,
13:30–15:00 EST) |
SELECT trial – New looks at glycemia, inflammation, and heart
failure (scientific session; 22 June, 08:00–09:00 EST) |
The STEP-HFpEF and STEP-HFpEF-DM trials – Targeting obesity to
treat heart failure (scientific session; 23 June, 16:30–18:00
EST) |
Poster and oral presentationsThe following
abstracts were submitted by Novo Nordisk and are accepted for
presentation at the congress:
Diabetes |
Ozempic® (once-weekly semaglutide 1.0 mg) |
- Comparative
effectiveness of semaglutide in T2D – year 2 results of a
randomized pragmatic clinical trial (230-OR)
|
- Long-term
effectiveness associated with maintenance doses of once-weekly
semaglutide in US adults with poorly controlled
T2D (766-P)
|
- Semaglutide in
patients with peripheral arterial disease and type 2 diabetes:
comorbidities and concomitant medications from the STRIDE trial
(784-P)
|
- Real-world impact
of once-weekly injectable semaglutide on weight, BMI and HbA1c
outcomes in type 2 diabetes: an observational study (PAUSE)
(857-P)
|
- Real-World Impact
of Once-Weekly Injectable Semaglutide (sema OW) vs. Sodium-Glucose
Cotransporter 2 Inhibitors (SGLT2i) on HbA1c, Weight, and Health
Care Resource Utilization (HCRU) Outcomes in Type 2 Diabetes (T2D)
- An Observational Study (PAUSE) (1884-LB)
|
Rybelsus® (once-daily oral semaglutide) |
- Evaluating the
efficacy of oral semaglutide in Chinese patients with T2D by
baseline characteristics: post hoc analysis of PIONEER 11 and 12
(752-P)
|
- Real-world impact
of fasting on adherence to dosing instructions and efficacy of oral
semaglutide during Ramadan in people with type 2 diabetes:
O-SEMA-Fast sub-analysis (808-P)
|
CagriSema |
- CagriSema improves
insulin sensitivity in diet-induced obese rats (763-P)
|
Once-weekly insulin icodec |
- Healthcare
resource utilization and costs with timely vs delayed basal insulin
initiation (816-P)
|
- Demographic,
clinical, and treatment characteristics of patients with timely vs.
delayed basal insulin initiation (817-P)
|
- No evidence of
increased physical activity-related hypoglycemia with once-weekly
insulin icodec versus once-daily basal insulin in T1D: ONWARDS 6
(824-P)
|
- Efficacy and
safety of once-weekly insulin icodec versus once-daily basal
insulin in individuals with T2D by kidney function: ONWARDS 1–5
(826-P)
|
- No evidence of
increased physical activity-related hypoglycemia with once-weekly
insulin icodec versus once-daily basal insulin in T2D: ONWARDS 1-5
(830-P)
|
- Adherence to
app-based dose guidance for once-weekly insulin icodec in
insulin-naive T2D: post hoc analysis of ONWARDS 5 (836-P)
|
- Impact of age on
the efficacy and safety of once-weekly insulin icodec versus
once-daily insulin in T2D (ONWARDS 1–5) (838-P)
|
- Efficacy and
safety of once-weekly insulin icodec versus once-daily basal
insulin in type 2 diabetes according to baseline glucagon-like
peptide-1 receptor agonist use: ONWARDS 1–5 (840-P)
|
- Efficacy and
safety of once-weekly insulin icodec vs once-daily basal insulin in
T2D by ethnicity and race: ONWARDS 1–5 (841-P)
|
- Cost-effectiveness
of insulin icodec for the treatment of type 2 diabetes in
Canada (1046-P)
|
- Efficacy and
safety outcomes with once-weekly insulin icodec versus once-daily
insulin degludec in T1D according to glycemic variability: ONWARDS
6 post hoc analysis (1882-LB)
|
Daily insulins |
- Influence of the
functionally selective insulin analog NNC-965 on cardiac structure
and function versus insulin glargine (IGla) (822-P)
|
- Improved glycemic
control in people with type 2 diabetes (T2D) initiating or
switching to insulin degludec/insulin aspart (IDegAsp) in a
real-world setting in China (publication only)
|
General diabetes |
- Persistence and
adherence of once weekly GLP-1 receptor agonists in patients with
type 2 diabetes and atherosclerotic cardiovascular disease in a
real-world setting (740-P)
|
- Impact of newer
GLP-1 RAs on HbA1c in US adults with type 2 diabetes: a
population-level time-series analysis (774-P)
|
- Understanding
attitudes about basal insulin: insights from a global survey of
people with type 2 diabetes (833-P)
|
- The value of the
guideline-recommended management of type 2 diabetes: A novel
population-level system dynamics approach (1040-P)
|
- Prevalence of
atherosclerotic cardiovascular diseases in adults with type 2
diabetes in Jordan: the PACT-MEA Study (1789-LB)
|
- In vivo
chain-splitting of human insulin (2032-LB)
|
Digital Health |
- Improvement in time in range after
smart insulin pen initiation in Austria (842-P)
|
- Multinational analysis of factors
associated with missed bolus insulin injections using smart pen
data (843-P)
|
Obesity |
Wegovy® (once-weekly semaglutide 2.4 mg) |
- CONCRETE –
characterization of patients receiving telemedicine and branded
antiobesity medication for medical weight management: a
retrospective analysis (1684-P)
|
- Clinical outcomes
in patients with obesity or overweight treated with semaglutide
2.4 mg: a real-world retrospective cohort study in the United
States (SCOPE 2) (1691-P)
|
- Modeling the
Impact of Semaglutide 2.4 mg in U.S. Patients with Atherosclerotic
Cardiovascular Disease and BMI ≥27 kg/m2 (1981-LB)
|
General obesity |
- Patient-centered
weight management clinical decision support: a proof-of-concept
study (1101-P)
|
- Prevalence,
characteristics, and clinical burden among patients with overweight
or obesity and established ASCVD in a US real world
setting (1692-P)
|
About Ozempic® Once-weekly
subcutaneous semaglutide is approved in 0.5 mg, 1.0 mg and 2.0 mg
doses under the brand name Ozempic® and indicated as an adjunct to
diet and exercise to improve glycaemic control in adults with type
2 diabetes and to reduce the risk of major adverse cardiovascular
events (cardiovascular death, non-fatal myocardial infarction or
non-fatal stroke) in adults with type 2 diabetes and established
cardiovascular disease.
About Rybelsus®Oral
semaglutide is administered once daily and is approved for use in
three therapeutic doses, 3 mg, 7 mg and 14 mg under the brand name
Rybelsus®. It is indicated for the treatment of adults with
insufficiently controlled type 2 diabetes mellitus to improve
glycaemic control as an adjunct to diet and exercise.
About Wegovy®Once-weekly
subcutaneous semaglutide 2.4 mg is approved under the brand name
Wegovy® and is indicated in combination with a reduced calorie diet
and increased physical activity to reduce the risk of major adverse
cardiovascular events (cardiovascular death, non-fatal myocardial
infarction, or non-fatal stroke) in adults with established
cardiovascular disease and either obesity or overweight, as well as
to reduce excess body weight and maintain weight reduction long
term in adults and paediatric patients aged 12 years and older with
obesity and in adults with overweight in the presence of at least
one weight-related comorbid condition.
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 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 66,000 people in 80 countries and markets its
products in around 170 countries. 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 |
Liz
Skrbkova (US)+1 609 917 0632lzsk@novonordisk.com |
Investors: |
|
Jacob
Martin Wiborg Rode+45 3075 5956jrde@novonordisk.com |
David
Heiberg Landsted +45 3077 6915 dhel@novonordisk.com |
Sina
Meyer +45 3079 6656azey@novonordisk.com |
Frederik
Taylor Pitter +45 3075 8259fptr@novonordisk.com |
Ida
Melvold Gjøsund+45 3077 5649 idmg@novonordisk.com |
Mark
Joseph Root (US) +1 848 213 3219mjhr@novonordisk.com |
_______________________References1. ClinicalTrials.gov.
A Research Study to See How Semaglutide Works Compared to Placebo
in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW).
Available at: https://clinicaltrials.gov/study/NCT03819153. Last
accessed: June 2024. 2. ClinicalTrials.gov.
Semaglutide Effects on Heart Disease and Stroke in Patients With
Overweight or Obesity (SELECT). Available
athttps://clinicaltrials.gov/study/NCT03574597. Last accessed: June
2024. 3. ClinicalTrials.gov. Research Study to
Investigate How Well Semaglutide Works in People Living With Heart
Failure and Obesity (STEP-HFpEF). Available at:
https://clinicaltrials.gov/study/NCT04788511. Last accessed: June
2024. 4. ClinicalTrials.gov. Research Study to
Look at How Well Semaglutide Works in People Living With Heart
Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM). Available at:
https://clinicaltrials.gov/study/ NCT04916470. Last accessed: June
2024.
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