Ozempic® demonstrated 2.1% blood sugar reduction and
also weight loss in adults with type 2 diabetes with new 2 mg dose1
March 28, 2022 /PRNewswire/ --
Novo Nordisk today announced that the US Food and Drug Administration
(FDA) has approved a 2 mg dose of Ozempic® (semaglutide)
injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog
indicated along with diet and exercise to improve blood sugar in
adults with type 2 diabetes and to reduce the risk of major
cardiovascular events such as heart attack, stroke or death in adults
with type 2 diabetes and known heart disease.2
Ozempic® is not a weight loss drug, but may help people
lose some weight. Ozempic® will be available in three
therapeutic doses (0.5 mg, 1 mg, and 2 mg) to help people with type 2
diabetes reach their blood sugar (A1C) goal, now including those with
a higher A1C who have been unable to meet their A1C target.
In the Ozempic® SUSTAIN phase 3 clinical trial program,
up to 73% of people with type 2 diabetes treated with
Ozempic® 1 mg lowered their blood sugar and reached the
American Diabetes Association target of <7%.3-5 Despite
this, there are still people who are not at their blood sugar
target.1,4-10 Ozempic® 2 mg helps those who need
additional glycemic control and is an important option for patients
and providers in the ongoing treatment of type 2 diabetes.
"Type 2 diabetes is a complex disease that can progress over
time even if a person is managing it with medication, diet and
exercise," said Dr Juan Pablo
Frias, medical director of Velocity Clinical Research, Los Angeles and principal investigator of
SUSTAIN FORTE, the phase 3 clinical trial that supports the
Ozempic® 2 mg approval. "With its proven safety and
efficacy, Ozempic® helps deliver on blood glucose control
and offers major cardiovascular event risk reduction in adults with
type 2 diabetes and known heart disease, plus it can help many
patients lose some weight. With a 2 mg dose, we have an additional
option so patients can stay on the same medication therapy even if
their blood sugar needs shift."
In the SUSTAIN FORTE trial, people with an average starting A1C of
8.9% treated with Ozempic® 2 mg achieved a statistically
significant and superior reduction in blood sugar of 2.1% at week 40
compared to 1.9% with Ozempic® 1 mg
(P<0.01).1 In the same study, people with an average
starting weight of 219 lb treated with Ozempic® 2 mg
experienced a weight loss of 14.1 lb compared to a weight loss of 12.5
lb with Ozempic® 1 mg; the difference was not statistically
significant. For both doses of Ozempic®, there were no new
safety signals identified.1 The most common adverse events
were gastrointestinal.1 Gastrointestinal adverse reactions
occurred more frequently among patients receiving Ozempic®
2 mg (34.0%) vs Ozempic® 1 mg (30.8%).1
"Ozempic® is at the helm of helping Novo Nordisk
drive change in diabetes care, with more than one million people with
type 2 diabetes in the United States
treated with Ozempic®," said Doug Langa, executive vice president, North America operations and president of
Novo Nordisk Inc. "With Ozempic® now available in a
variety of dosing strengths, we are optimistic we can help even more
people living with type 2 diabetes who require more blood sugar
control experience the benefits of Ozempic®."
Novo Nordisk expects to launch Ozempic® 2 mg in the United States shortly.
Ozempic® 2 mg was approved by Swiss Medic in September 2021 followed by Health Canada and
the European Medicines Agency in January 2022.
For health care professionals looking for more information about
Ozempic®, please visit OzempicPro.com. For consumers
looking for more information about Ozempic®, please visit
About the SUSTAIN FORTE clinical trial
The SUSTAIN FORTE trial was a part of the SUSTAIN clinical
development program for once-weekly Ozempic®. SUSTAIN FORTE
studied the efficacy and safety of Ozempic® 2 mg vs
Ozempic® 1 mg as add-on to metformin with or without a
sulfonylurea in people with type 2 diabetes in need of treatment
intensification.1 The trial achieved its primary endpoint
by demonstrating a statistically significant and superior reduction in
A1C at week 40 with Ozempic® 2 mg compared to
Ozempic® 1 mg.1
For more information about the SUSTAIN FORTE trial, please read the
What is Ozempic®?
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is
an injectable prescription medicine used:
- along with diet and exercise to improve blood sugar (glucose) in
adults with type 2 diabetes mellitus.
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 disease.
It is not known if Ozempic® can be used in people who have
Ozempic® is not for use in people
with type 1 diabetes.
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®. See symptoms of serious allergic reaction in
"What are the possible side effects of 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 swelling of your face, lips,
tongue, or throat; problems breathing or swallowing; severe rash or
itching; fainting or feeling dizzy; or very rapid heartbeat.
gallbladder problems. Gallbladder problems have happened in
some people who take Ozempic®. Tell your healthcare
provider right away if you get symptoms which may include: pain in
your upper stomach (abdomen), fever, yellowing of the skin or eyes
(jaundice) or clay-colored stools.
The most common side effects of Ozempic
may include nausea, vomiting, diarrhea, stomach (abdominal)
pain, and constipation.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been
making innovative medicines to help people with diabetes lead
longer, healthier lives for more than 95 years. This heritage has
given us experience and capabilities that also enable us to drive
change to help people defeat other serious chronic diseases such as
obesity and rare blood and endocrine disorders. We remain steadfast
in our conviction that the formula for lasting success is to stay
focused, think long term and do business in a financially, socially
and environmentally responsible way. With US headquarters in New Jersey and production and research
facilities in seven states, Novo Nordisk employs nearly 6,000 people
throughout the country. For more information, visit
novonordisk.us, Facebook , Instagram and Twitter.
- Frias JP, Auerbach P, Bajaj HS, et al. Efficacy and safety of
once-weekly semaglutide 2.0 mg versus 1.0 mg in patients with type 2
diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial. Lancet Diabetes Endocrinol. 2021;9:563-574.
- FDA. Ozempic® (semaglutide) injection US Prescribing
Information. Accessed March 2022. https://www.novo-pi.com/ozempic.pdf.
- American Diabetes Association. Standards of medical care in
diabetes - 2022. Diabetes Care. 2022;45(suppl 1):S1-258
- Sorli C, Harashima SI, Tsoukas GM, et al. Efficacy and safety of
once-weekly semaglutide monotherapy versus placebo in patients with
type 2 diabetes (SUSTAIN 1): a double-blind, randomised,
placebo-controlled, parallel-group, multinational, multicentre phase
3a trial. Lancet Diabetes Endocrinol. 2017;5:251-260.
- Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus
dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN
7): a randomised, open-label, phase 3b
trial. Lancet Diabetes Endocrinol. 2018;6:275-286.
- Ahren B, Masmiquel L, Kumar H, et al. Efficacy and safety of
once-weekly semaglutide versus once-daily sitagliptin as an add-on
to metformin, thiazolidinediones, or both, in patients with type 2
diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised
trial. Lancet Diabetes Endocrinol. 2017;5:341-354.
- Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and safety
of once-weekly semaglutide versus exenatide ER in subjects with type
2 diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical
Trial. Diabetes Care. 2018;41:258-266.
- Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of
once-weekly semaglutide versus once-daily insulin glargine as add-on
to metformin (with or without sulfonylureas) in insulin-naive
patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label,
parallel-group, multicentre, multinational, phase 3a trial.
Lancet Diabetes Endocrinol. 2017;5:355-366.
- Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal
insulin in type 2 diabetes (SUSTAIN 5): A Randomized, Controlled
Trial. J Clin Endocrinol Metab. 2018;103:2291-2301.
- Gaede P, Catarig A-M, Dungan KM, Hindsberger C, Ølligaard J, Bain
SC. 660-P: Greater proportions of subjects achieved composite
endpoints with once-weekly semaglutide vs. comparators in SUSTAIN
Trials. Diabetes. 2021;70(Supplement_1). doi:10.2337/db21-660-p
Ozempic® is a registered trademark of Novo Nordisk
Novo Nordisk is a registered trademark of Novo Nordisk
© 2022 Novo Nordisk All rights reserved. US21OZM01000
SOURCE Novo Nordisk