Diabetes Pro Quarterly - Summer 2019 - 11

Based on study protocol insulin titration, in insulin-naïve
patients on metformin with or without sulfonylurea

Primary endpoint: Mean change in A1C from baseline at Week 302

Estimated mean change
in A1C from baseline (%)

Baseline: 8.1%

-0.9%*

Baseline: 8.1%

-1.2%*

n=360

n=362

Baseline: 8.2%

-1.5%*
n=360

26% of insulin patients
titrated to goal by
Week 30. Mean daily
insulin dose: 29 U/day.2

*P<0.0001

Lantus®

Secondary endpoint: Mean change in body weight from baseline at Week 302
Baseline: 204 lb

Change in body weight
from baseline (lb)a

Ozempic® is
not indicated for
weight loss.

+2.0 llbb*†

Baseline: 207 lb

-7.1
-7
-
7.1 llbb*

n=360

n=362

Baseline: 207 lb

-10.4
-
10.4 llbb†
n=360

*ETD=-9.0 lb (95% CI; -10.8, -7.3)
†
ETD=-12.3 lb (95% CI; -14.1, -10.6)

Lantus

Estimated mean.
SUSTAIN 4: A 30-week, randomized, open-label, active-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic® vs insulin glargine U-100. A total
of 1089 insulin-naïve adult patients with type 2 diabetes inadequately controlled on metformin alone (48%) or in combination with a sulfonylurea (51%) were randomized to receive once-weekly
Ozempic® 0.5 mg (n=362), once-weekly Ozempic® 1 mg (n=360), or once-daily insulin glargine U-100 (n=360). Patients assigned to insulin glargine had a baseline mean A1C of 8.1% and were started
on a dose of 10 U once daily. Insulin glargine dose adjustments occurred throughout the trial period based on self-measured fasting plasma glucose before breakfast, targeting 71 to <100 mg/dL. In
addition, investigators could titrate insulin glargine at their discretion between study visits. 26% of patients had been titrated to goal by the primary endpoint at Week 30, at which time the mean
daily insulin dose was 29 units per day. The primary endpoint was mean change in A1C from baseline at Week 30. Mean change in body weight at Week 30 was a secondary endpoint.1,2

* 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. 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(5):355-366. 2. Ozempic [package insert]. Plainsboro, NJ:
Novo Nordisk Inc; 2017. 3. Marso SP, Bain SC, Consoli A, et al; SUSTAIN-6 Investigators. Semaglutide and
cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834-1844.

Diabetes Pro Quarterly - Summer 2019

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