ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Ozempic®
(semaglutide) injection 0.5 mg or 1 mg provided greater weight
reductions vs dulaglutide 0.75 mg or 1.5 mg, respectively, in
adults with type 2 diabetes, regardless of baseline body mass index
(BMI), with the greatest reductions occurring in adults with a
baseline BMI ≥25 kg/m2. While the primary endpoint of
SUSTAIN 7 was change in A1C, this post-hoc exploratory analysis
examined the secondary endpoint of change in body weight by
baseline BMI.1 The results will be presented on
June 24, 2018 at the American
Diabetes Association's 78th Scientific Sessions (ADA) in
Orlando, Fla.
Greater weight reductions were demonstrated across all BMI
subgroups (<25, 25–<30, 30–<35, ≥35 kg/m2) with
Ozempic® 0.5 mg vs dulaglutide 0.75 mg (range of weight
reduction across all subgroups: 3.6–5.5 kg vs 0.9–3.4
kg) and with Ozempic® 1 mg vs dulaglutide 1.5 mg (range
of weight reduction across all subgroups: 5.2–7.6 kg vs
2.0–3.8 kg), from a mean baseline of 95.2 kg.1
Adults with a higher baseline BMI (≥25 kg/m2) taking
Ozempic® generally achieved greater weight reductions
than those with lower baseline BMI (<25 kg/m2).
In addition, more people achieved weight reduction of ≥5% and
≥10% with Ozempic® vs dulaglutide in all BMI
subgroups.
"Globally, up to ninety percent of people with type 2 diabetes
are overweight or have obesity.2 Therefore, it is
important to consider how to manage weight in this population,"
said Dr. Adie Viljoen, SUSTAIN
7 chief investigator and consultant chemical pathologist, East and
North Hertfordshire NHS Trust, UK. "Based on the SUSTAIN clinical
trial programme, Ozempic® can help people living with
type 2 diabetes manage their A1C and has the potential to help them
lose some weight."
Across BMI subgroups, fewer people reported gastrointestinal
(GI) adverse events with the low dulaglutide dose (0.75 mg)
compared with the other three treatment groups (Ozempic®
0.5 and 1 mg, and dulaglutide 1.5 mg). The most common adverse
events (≥5%) for both Ozempic® dosages were GI adverse
events.
About Ozempic®
Ozempic® (semaglutide) injection 0.5 mg or 1 mg is
a once-weekly glucagon-like peptide (GLP-1) receptor agonist
indicated as an adjunct to diet and exercise to improve glycaemic
control in adults with type 2 diabetes.3
Ozempic® was approved by the U.S. Food and Drug
Administration on December 5, 2017,
by Health Canada on January 4, 2018,
by the European Commission on February 9,
2018 and on March 23 by the
Japanese Ministry of Health, Labour and Welfare.3-6
About the SUSTAIN clinical trial programme
The
SUSTAIN global clinical development programme for
Ozempic® comprises eight phase 3a trials, encompassing
more than 8,000 adults with type 2 diabetes. The phase 3a programme
involves a broad range of people with type 2 diabetes, including
some with high cardiovascular risk profiles.
The primary analysis of the SUSTAIN 7 trial was published in
The Lancet Diabetes & Endocrinology in January 2018. The primary outcome measure was
change in A1C from baseline after 40 weeks of treatment. Change in
body weight from baseline to week 40 was a predefined secondary
endpoint.7 In this post-hoc exploratory analysis, which
was conducted using Mixed Models for Repeated Measurements, the
interaction effect between treatment and subgroup was not
statistically significant (semaglutide 0.5 mg vs dulaglutide 0.75
mg: p= 0.9118; semaglutide 1 mg vs dulaglutide 1.5 mg: p=
0.8175).
What is Ozempic®?
Ozempic® (semaglutide) injection 0.5 mg or 1 mg is an
injectable prescription medicine for adults with type 2 diabetes
that along with diet and exercise may improve blood sugar.
- Ozempic® is not recommended as the first choice of
medicine for treating diabetes. It is not known if
Ozempic® can be used in people who have had
pancreatitis.
- Ozempic® is not a substitute for insulin and is not
for use in people with type 1 diabetes or people with diabetic
ketoacidosis.
- It is not known if Ozempic® is safe and effective
for use in children under 18 years of age.
Important Safety Information
Do not share your Ozempic® pen with other
people, even if the needle has been changed. You may give
other people a serious infection, or get a serious infection from
them.
What is the most important information I should know about
Ozempic®?
Ozempic®
may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your
health care provider if you get a lump or swelling in your neck,
hoarseness, trouble swallowing, or shortness of breath. These may
be symptoms of thyroid cancer. In studies with rodents,
Ozempic® and medicines that work like
Ozempic® caused thyroid tumors, including thyroid
cancer. It is not known if Ozempic® will cause thyroid
tumors or a type of thyroid cancer called medullary thyroid
carcinoma (MTC) in people.
- Do not use Ozempic® if you or any of your family
have ever had MTC, or if you have an endocrine system condition
called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use Ozempic® if:
- you or any of your family have ever had MTC or if you have MEN
2.
- you are allergic to semaglutide or any of the ingredients in
Ozempic®.
Before using Ozempic®, tell your health
care provider if you have any other medical conditions, including
if you:
- have or have had problems with your pancreas or kidneys.
- have a history of diabetic retinopathy.
- are pregnant or breastfeeding or plan to become pregnant or
breastfeed. It is not known if Ozempic® will harm your
unborn baby or passes into your breast milk. You should stop using
Ozempic® 2 months before you plan to become
pregnant.
Tell your health care provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, herbal supplements, and other medicines to treat
diabetes, including insulin or sulfonylureas.
What are the possible side effects of
Ozempic®?
Ozempic®
may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using
Ozempic® and call your health care provider right away
if you have severe pain in your stomach area (abdomen) that will
not go away, with or without vomiting. You may feel the pain from
your abdomen to your back.
- changes in vision. Tell your health care provider if you
have changes in vision during treatment with
Ozempic®.
- low blood sugar (hypoglycemia). Your risk for getting
low blood sugar may be higher if you use Ozempic® with
another medicine that can cause low blood sugar, such as a
sulfonylurea or insulin. Signs and symptoms of low blood sugar
may include: dizziness or lightheadedness, blurred vision,
anxiety, irritability or mood changes, sweating, slurred speech,
hunger, confusion or drowsiness, shakiness, weakness, headache,
fast heartbeat, and feeling jittery.
- kidney problems (kidney failure). In people who have
kidney problems, diarrhea, nausea, and vomiting may cause a loss of
fluids (dehydration), which may cause kidney problems to get worse.
It is important for you to drink fluids to help reduce your chance
of dehydration.
- serious allergic reactions. Stop using
Ozempic® and get medical help right away if you have any
symptoms of a serious allergic reaction, including itching, rash,
or difficulty breathing.
The most common side effects of Ozempic®
may include nausea, vomiting, diarrhea, stomach (abdominal)
pain, and constipation.
Please see Medication Guide and Prescribing Information,
including Boxed Warning for Ozempic®,
at http://www.novo-pi.com/ozempic.pdf.
About Novo Nordisk
Novo Nordisk, a
global healthcare company, has been committed to discovering and
developing innovative medicines to help people living with diabetes
lead longer, healthier lives for 95 years. This heritage has given
us experience and capabilities that also enable us to help people
defeat other serious diseases including obesity, hemophilia and
growth disorders. We remain steadfast in our conviction that the
formula for success is to stay focused, think long term and do
business in a financially, socially and environmentally responsible
way. With U.S. headquarters in New
Jersey and production and research facilities in four
states, Novo Nordisk employs nearly 6,000 people throughout the
country. For more information, visit novonordisk.us,
Facebook and Twitter.
References:
- Viljoen A, Blüher M, Chow F, et al. Semaglutide reduces
body weight vs dulaglutide across baseline BMI subgroups in SUSTAIN
7. Abstract 1083-P. 78th Scientific Sessions of the American
Diabetes Association (ADA), Orlando, USA;
22-26 June 2018.
- World Health Organization. Global Strategy on Diet, Physical
Activity and Health.
http://www.who.int/dietphysicalactivity/media/en/gsfs_obesity.pdf.
Updated 2003. Last accessed: June
2018.
- Novo Nordisk. Ozempic® Prescribing Information.
Available at: http://www.novo-pi.com/ozempic.pdf. Last accessed:
June 2018.
- Novo Nordisk. Ozempic® Canada Product Monograph.
Available at https://pdf.hres.ca/dpd_pm/00043163.PDF. Last
accessed: June 2018.
- EMA. Ozempic® (semaglutide) SmPC. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR
Product_Information/human/004174/WC500244163.pdf. Last accessed:
June 2018.
- Novo Nordisk. Ozempic® approved in Japan for the treatment of type 2 diabetes.
Available at:
https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2178681.html.
Last accessed: June 2018.
- Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide once
weekly versus dulaglutide once weekly in patients with type 2
diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. The Lancet Diabetes &
Endocrinology. 2018.
Ozempic® is a registered trademark of Novo Nordisk
A/S.
Novo Nordisk is a registered trademark of Novo Nordisk
A/S.
All other trademarks, registered or unregistered, are the property
of their respective owners
© 2018 Novo Nordisk All rights
reserved.
US18OZM00229 June
2018
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SOURCE Novo Nordisk