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WATCH VIDEO 12:03

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CONSIDER WHY ONCE-WEEKLY OZEMPIC® SHOULD BE THE FIRST INJECTABLE FOR MOST
PATIENTS

Consider why
a GLP-1 RA therapy once-weekly Ozempic® should be the
first injectable
for most patients
See why it’s time to think of prescribing a glucagon-like peptide-1 (GLP-1) RA
therapy prior to basal insulin for your appropriate adult patients with type 2
diabetes.
This program is sponsored by Novo Nordisk. Dr Craig Wierum and Lisa Coco, NP,
received a fee from Novo Nordisk Inc. for their participation in this video.

PEER INSIGHTS




IS IT TIME TO RECONSIDER YOUR OPTIONS?

You have options when it comes to prescribing the first injectable for your
adult patients with type 2 diabetes. Hear from 2 health care professionals on
why they choose a GLP-1 RA therapy as the first injectable for some of their
patients.



CRAIG WIERUM | MD, FACE

Endocrinologist
Heritage Medical Associates
Nashville, TN



LISA COCO | NP

Board Certified Registered Nurse Practitioner, Certified Diabetes Care and
Education Specialist
Jefferson University Physicians
Philadelphia, PA


GLP-1 RA therapy before basal insulin

When additional glycemic control is needed, many health care professionals
prescribe a basal insulin as their adult patients’ first injectable after
metformin. While there are patients who benefit from the use of a basal insulin,
there are other options that may help patients reach their A1C goals.

The ADA guidelines recommend GLP-1 RA therapies prior to basal insulin for most
adult patients with type 2 diabetes who need the greater efficacy of an
injectable medication. This recommendation is based on efficacy, side effects,
cost, and patient preferences.1

Watch peer perspectives on treatment
Get peer perspectives on the ADA guidelines

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View Ozempic® Prescribing Information

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View Ozempic® Prescribing Information
Treatment options
ADA guidelines
GLP-1 RA therapy before basal insulin

When additional glycemic control is needed, many health care professionals
prescribe a basal insulin as their adult patients’ first injectable after
metformin. While there are patients who benefit from the use of a basal insulin,
there are other options that may help patients reach their A1C goals.

The ADA guidelines recommend GLP-1 RA therapies prior to basal insulin for most
adult patients with type 2 diabetes who need the greater efficacy of an
injectable medication. This recommendation is based on efficacy, side effects,
cost, and patient preferences.1

Watch peer perspectives on treatment
Get peer perspectives on the ADA guidelines

Your browser does not support html5 video


View Ozempic® Prescribing Information
How do you treat your adult patients with type 2 diabetes?

“In my experience, my peers are more familiar with basal insulin and understand
the benefits and side effects. There would be a huge impact if they knew about
the once-weekly dosing options available with GLP-1 RA therapies.2

When I talk with my patients, I take my time explaining the guidelines and
treatment, as well as what causes hypoglycemic events. I stress that every
treatment plan is different for each patient and patients like that GLP-1 RA
therapy offers once-weekly dosing.”

Lisa Coco NP

Get peer perspectives on the ADA guidelines
Return to overview

Your browser does not support html5 video


View Ozempic® Prescribing Information
How does the ADA change the way you prescribe?

“The ADA guidelines recommend GLP-1 RA therapies for most patients with type 2
diabetes who need the greater glucose-lowering effect of an injectable
medication.1 I take into consideration the once-weekly dosing options, efficacy,
cost, and tolerability issues when prescribing a treatment.”1

Craig Wierum MD, FACE

See how my peers are treating
Return to overview



MECHANISM OF ACTION



The different ways GLP-1 RA therapy and basal insulin work after entering the
bloodstream



GLP-1 RA therapy:




Signals the pancreas

 * To release the body’s own insulin, if blood sugar is high3,4
 * To lower glucagon secretion, which signals the liver to stop releasing
   glucose into the blood3,4




Works in the gut by slowing gastric emptying3



Basal insulin:




Signals muscle and fat cells to absorb sugar and turn it into energy5




Signals the liver to store sugar instead of releasing it into the blood5



“When I am deciding on a first injection for my patients, I consider A1C
results, rates of hypoglycemia, and dosing schedule.”

CRAIG WIERUM | MD, FACE




SUSTAIN 4



See how once-weekly Ozempic® compared to Lantus® in a head-to-head trial3,6



When patients are no longer reaching their A1C goals with oral medications and
you are thinking about their first injectable, it’s important to consider the
efficacy of the treatments you prescribe. The SUSTAIN 4 clinical trial was
designed to compare the efficacy and safety of Ozempic® versus study-titrated
Lantus® in adult patients with type 2 diabetes.2,6




PATIENTS:

1089

KEY INCLUSION CRITERIA:

Insulin-naïve, T2D, inadequately controlled on metformin alone or in combination
with sulfonylurea

STUDY DESIGN:

30-week, randomized, open-label, active-controlled, parallel-group,
multinational, multicenter trial. 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.

See full study design



PRIMARY ENDPOINT



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

Ozempic® demonstrated statistically significant A1C reductions vs Lantus®2,6



Primary endpoint: Mean change in A1C from baseline at Week 30





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

Results are from a 30-week, randomized, open-label, active-controlled trial in
1089 adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and
Ozempic® 1 mg to Lantus®.2,6

“My peers and I were quite surprised by the A1C results in SUSTAIN 4. There were
greater A1C reductions with Ozempic® vs study-titrated Lantus®.”2

CRAIG WIERUM  | MD, FACE




SECONDARY ENDPOINT



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

Ozempic® demonstrated statistically significant reduction in body weight vs
Lantus®2,6

Ozempic® is not indicated for weight loss.



Secondary endpoint: Mean change in body weight from baseline at Week 30





Results are from a 30-week, randomized, open-label, active-controlled trial in
1089 adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and
Ozempic® 1 mg to Lantus®.2,6

CI=confidence interval; ETD=estimated treatment difference.

“Even though Ozempic® is not indicated for weight loss, I was impressed by the
approximate 12-lb mean weight difference with Ozempic® 1 mg vs study-titrated
Lantus®.”2

Lisa Coco  |  NP




ADVERSE EVENTS




ADVERSE EVENTS (AES) OCCURRING IN ≥5% OF PARTICIPANTS IN SUSTAIN 46

SUSTAIN 4 was not designed to evaluate relative safety between Ozempic® and
Lantus®

 * In placebo-controlled trials, the most common adverse reactions reported in
   ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea,
   abdominal pain, and constipation2
 * Because clinical trials are conducted under widely varying conditions,
   adverse reaction rates observed in the clinical trials of a drug cannot be
   directly compared to rates in the clinical trials of another drug and may not
   reflect the rates observed in practice2
 * Comparator adverse event rates are not an adequate basis for comparison of
   safety between products
 * Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled
   trials2
 * Incidence of severe hypoglycemia or blood glucose-confirmed hypoglycemia (%
   of patients) was 4% with Ozempic® 0.5 mg, 6% with Ozempic® 1 mg, and 11% with
   Lantus®6,a



AE=adverse events; GI=gastrointestinal.
aDefined as an event requiring assistance of another person to actively
administer carbohydrates or glucagon, or take other corrective actions or blood
glucose-confirmed symptomatic hypoglycemia (plasma glucose ≤3.1 mmol/L [56
mg/dL]).6
Results from a 30-week, randomized, open-label, active-controlled trial in 1089
adult, insulin-naïve patients with type 2 diabetes.2,6




Consider once-weekly
Ozempic® for your
appropriate T2D patients




"When patients are not reaching their A1C goals on oral therapy, you may need to
consider reaching for a different type of injectable option other than insulin.”

CRAIG WIERUM | MD, FACE

"When I explain that they only need to inject Ozempic® once a week, it usually
helps alleviate patient concerns about taking injections.”

LISA COCO | NP




Consider once-weekly Ozempic® for your appropriate T2D patients



"When patients are not reaching their A1C goals on oral therapy, you may need to
consider reaching for a different type of injectable option other than insulin.”

CRAIG WIERUM | MD, FACE



"When I explain that they only need to inject Ozempic® once a week, it usually
helps alleviate patient concerns about taking injections.”

LISA COCO | NP




STUDY DESIGN



SUSTAIN 4: Head-to-head vs Lantus® (insulin glargine U-100)2,6

Study design: 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.

Patients: 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 units 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 based on their discretion between
study visits. Twenty-six percent 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.

Primary endpoint: Mean change in A1C from baseline at Week 30.

Secondary endpoint: Mean change in body weight from baseline at Week 30.




See the insulin response of patients taking Ozempic® vs healthy people


View results



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Help patients realize the potential with Ozempic®

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IMPORTANT SAFETY INFORMATION FOR OZEMPIC® (SEMAGLUTIDE) INJECTION 0.5 MG OR 1 MG

WARNING: RISK OF THYROID C-CELL TUMORS

 * In rodents, semaglutide causes dose-dependent and
   treatment-duration-dependent 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 (eg, 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®.


INDICATIONS 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 and to reduce the risk of major adverse cardiovascular (CV) events (CV
death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2
diabetes mellitus and established CV disease.

 * 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 indicated for use in patients with type 1 diabetes mellitus.


IMPORTANT SAFETY INFORMATION CONT.


CONTRAINDICATIONS

 * Ozempic® is contraindicated in patients with a personal or family history of
   MTC or in patients with MEN 2, and in patients with a prior hypersensitivity
   reaction to semaglutide or to any of the excipients in Ozempic®. Serious
   hypersensitivity reactions including anaphylaxis and angioedema have been
   reported with Ozempic®.


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 with 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.
 * 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: Patients receiving Ozempic® in combination with an insulin
   secretagogue (eg, sulfonylurea) or insulin may have an increased risk of
   hypoglycemia, including severe hypoglycemia. Inform patients using these
   concomitant medications of the risk of hypoglycemia and educate them on the
   signs and symptoms of hypoglycemia.
 * 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 (eg, anaphylaxis,
   angioedema) have been reported in patients treated with Ozempic®. 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.


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

 * When initiating Ozempic®, consider reducing the dose of concomitantly
   administered insulin secretagogue (such as sulfonylureas) or insulin to
   reduce the risk of hypoglycemia.
 * 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 click here for Ozempic® Prescribing Information, including Boxed Warning.

 



References:

 1. American Diabetes Association. Pharmacologic approaches to glycemic
    treatment: standards of medical care in diabetes—2021. Diabetes
    Care. 2021;44(Suppl.1):S111-S124.
 2. Ozempic® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; April 2021.
 3. Drucker DJ. The biology of incretin hormones. Cell Metab. 2006;3:153-165.
 4. Campbell JE, Drucker DJ. Pharmacology, physiology, and mechanisms of
    incretin hormone action. Cell Metab. 2013;17(6):819-837.
 5. Dimitriadis G, Mitrou P, Lambadiari V, Maratou E, Raptis S. Insulin effects
    in muscle and adipose tissue. Diabetes Res Clin Pract. 2011;93S:S52-S59.
 6. 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-naïve patients with type 2 diabetes
    (SUSTAIN 4): a randomized, open-label, parallel-group, multicenter,
    multinational, phase 3a trial. Lancet Diabetes
    Endocrinol. 2017:5(5):355-366.

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IMPORTANT SAFETY INFORMATION FOR OZEMPIC® (SEMAGLUTIDE) INJECTION 0.5 MG OR 1 MG

WARNING: RISK OF THYROID C-CELL TUMORS

 * In rodents, semaglutide causes dose-dependent and
   treatment-duration-dependent 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 (eg, 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®.


INDICATIONS 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 and to reduce the risk of major adverse cardiovascular (CV) events (CV
death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2
diabetes mellitus and established CV disease.

 * 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 indicated for use in patients with type 1 diabetes mellitus.


IMPORTANT SAFETY INFORMATION CONT.


CONTRAINDICATIONS

 * Ozempic® is contraindicated in patients with a personal or family history of
   MTC or in patients with MEN 2, and in patients with a prior hypersensitivity
   reaction to semaglutide or to any of the excipients in Ozempic®. Serious
   hypersensitivity reactions including anaphylaxis and angioedema have been
   reported with Ozempic®.


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 with 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.
 * 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: Patients receiving Ozempic® in combination with an insulin
   secretagogue (eg, sulfonylurea) or insulin may have an increased risk of
   hypoglycemia, including severe hypoglycemia. Inform patients using these
   concomitant medications of the risk of hypoglycemia and educate them on the
   signs and symptoms of hypoglycemia.
 * 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 (eg, anaphylaxis,
   angioedema) have been reported in patients treated with Ozempic®. 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.


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

 * When initiating Ozempic®, consider reducing the dose of concomitantly
   administered insulin secretagogue (such as sulfonylureas) or insulin to
   reduce the risk of hypoglycemia.
 * 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 click here for Ozempic® Prescribing Information, including Boxed Warning.

 



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