Diabetes Pro Quarterly - Fall 2019 - 9

In a 40-week trial, in patients on metformin, for each dose comparison

Ozempic® outperformed Trulicity® in reducing A1C1

Secondary endpoint

Ozempic® demonstrated superior body weight reduction vs Trulicity®1
Ozempic® is not indicated for weight loss.

SUSTAIN 7: A 40-week, multinational, multicenter, randomized, open-label, four-armed, pair-wise, active-controlled, parallel-group trial to compare the efficacy and safety of Ozempic®
vs dulaglutide. A total of 1201 adult patients with type 2 diabetes inadequately controlled on metformin were randomized to receive Ozempic® 0.5 mg (n=301), Ozempic® 1 mg (n=300),
dulaglutide 0.75 mg (n=299), or dulaglutide 1.5 mg (n=299) once weekly. The primary endpoint was mean change in A1C from baseline at Week 40. Secondary endpoints included
mean change in body weight at Week 40 and proportion of patients achieving A1C <7% at Week 40. Results based on a sensitivity analysis of retrieved dropout population.1

Learn more about Ozempic® and the CVOT at OzempicPro.com.
* Never Share an Ozempic® Pen Between Patients: Ozempic® pens must
never be shared between patients, even if the needle is changed. Pen-sharing poses
a risk for transmission of blood-borne pathogens.
* Hypoglycemia: The risk of hypoglycemia is increased when Ozempic® is used in
combination with insulin secretagogues (e.g., sulfonylureas) or insulin.
* Acute Kidney Injury: There have been postmarketing reports of acute kidney
injury and worsening of chronic renal failure, which may sometimes require
hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these
events have been reported in patients without known underlying renal disease. A
majority of the reported events occurred in patients who had experienced nausea,
vomiting, diarrhea, or dehydration. Monitor renal function when initiating or
escalating doses of Ozempic® in patients reporting severe adverse gastrointestinal
reactions.
* Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema)
have been reported with GLP-1 receptor agonists. If hypersensitivity reactions
occur, discontinue use of Ozempic®; treat promptly per standard of care, and
monitor until signs and symptoms resolve. Use caution in a patient with a history of
angioedema or anaphylaxis with another GLP-1 receptor agonist.
* Macrovascular Outcomes: There have been no clinical studies establishing
conclusive evidence of macrovascular risk reduction with Ozempic®.
Adverse Reactions
* The most common adverse reactions, reported in ≥5% of patients treated with
Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.

Drug Interactions
* The risk of hypoglycemia may be lowered by a reduction in the dose of the secretagogue
or insulin.
* Ozempic® causes a delay of gastric emptying and has the potential to impact the
absorption of concomitantly administered oral medications, so caution should
be exercised.
Use in Specific Populations
* There are limited data with semaglutide use in pregnant women to inform a
drug-associated risk for adverse developmental outcomes. Discontinue Ozempic® in
women at least 2 months before a planned pregnancy due to the long washout
period for semaglutide.

Please see Brief Summary of Prescribing Information on
following pages.
GLP-1 RA=glucagon-like peptide-1 receptor agonist; CV=cardiovascular; CVOT=cardiovascular outcomes trial;
ETD=estimated treatment difference; CI=confidence interval.

References: 1. 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(4):275-286. 2. Ozempic [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
3. Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2
diabetes. N Engl J Med. 2016;375(19):1834-1844.

http://www.OzempicPro.com

Diabetes Pro Quarterly - Fall 2019

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