Diabetes Pro Quarterly - Fall 2019 - 8

For adult patients with type 2 diabetes,
treated with diet and exercise

Choose Ozempic® as your first injectable-
the only once-weekly GLP-1 RA with
superior results vs Trulicity ®1,2

SUPERIOR GLYCEMIC CONTROL

SUPERIOR WEIGHT REDUCTION
Ozempic® is not indicated for weight loss.

CV SAFETY
as evaluated in a 2-year CVOT.2
Ozempic® is not indicated for reduction
in major adverse CV events (MACE).
SUSTAIN 6: A 2-year, randomized, multinational, double-blind, placebo-controlled, parallel-group CV safety trial that was designed to assess noninferiority of Ozempic® vs
standard of care by excluding the preapproval noninferiority margin of 1.8. A total of 3297 adult patients with type 2 diabetes and high risk of CV events were randomized based
on evidence of CV disease, insulin treatment, and renal impairment to once-weekly Ozempic® 0.5 mg (n=826), Ozempic® 1 mg (n=822), or placebo (n=1649) in addition to
standard of care treatments such as oral antidiabetic treatments, insulin, antihypertensives, diuretics, lipid-lowering therapies, and antithrombotic medication at investigator
discretion. The primary composite endpoint was the time from randomization to first occurrence of a MACE, defined as CV death, nonfatal myocardial infarction, or nonfatal stroke.3

Indication and Limitations of Use

Ozempic® (semaglutide) injection 0.5 mg or 1 mg is indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes mellitus.
* Ozempic® is not recommended as a first-line therapy for patients who have inadequate
glycemic control on diet and exercise because of the uncertain relevance of rodent
C-cell tumor findings to humans.
* Ozempic® has not been studied in patients with a history of pancreatitis. Consider
other antidiabetic therapies in patients with a history of pancreatitis.
* Ozempic® is not a substitute for insulin. Ozempic® is not indicated for use in patients
with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis.

Important Safety Information
WARNING: RISK OF THYROID C-CELL TUMORS
* In rodents, semaglutide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors at clinically relevant exposures. It is
unknown whether Ozempic® causes thyroid C-cell tumors, including
medullary thyroid carcinoma (MTC), in humans as human relevance of
semaglutide-induced rodent thyroid C-cell tumors has not been determined.
* Ozempic® is contraindicated in patients with a personal or family history of
MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2
(MEN 2). Counsel patients regarding the potential risk for MTC with the
use of Ozempic® and inform them of symptoms of thyroid tumors (e.g. a
mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine
monitoring of serum calcitonin or using thyroid ultrasound is of uncertain
value for early detection of MTC in patients treated with Ozempic®.

Contraindications
* Ozempic® is contraindicated in patients with a personal or family history of MTC or
in patients with MEN 2, and in patients with known hypersensitivity to semaglutide
or to any of the product components.
Warnings and Precautions
* Risk of Thyroid C-Cell Tumors: Patients should be referred to an endocrinologist
for further evaluation if serum calcitonin is measured and found to be elevated or
thyroid nodules are noted on physical examination or neck imaging.
* Pancreatitis: Acute and chronic pancreatitis have been reported in clinical studies.
Observe patients carefully for signs and symptoms of pancreatitis (persistent severe
abdominal pain, sometimes radiating to the back with or without vomiting). If
pancreatitis is suspected, discontinue Ozempic ® promptly, and if pancreatitis
is confirmed, do not restart.
* Diabetic Retinopathy Complications: In a 2-year trial involving patients
with type 2 diabetes and high cardiovascular risk, more events of diabetic
retinopathy complications occurred in patients treated with Ozempic® (3.0%)
compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy
complications was larger among patients with a history of diabetic retinopathy at
baseline than among patients without a known history of diabetic retinopathy.
Rapid improvement in glucose control has been associated with a temporary
worsening of diabetic retinopathy. The effect of long-term glycemic control with
semaglutide on diabetic retinopathy complications has not been studied. Patients
with a history of diabetic retinopathy should be monitored for progression of
diabetic retinopathy.

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.
© 2019 Novo Nordisk
Printed in the U.S.A.
US19OZM00110
March 2019

Diabetes Pro Quarterly - Fall 2019

Table of Contents for the Digital Edition of Diabetes Pro Quarterly - Fall 2019