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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 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

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

CRAIG WIERUM | MD, FACE

Endocrinologist
Heritage Medical Associates
Nashville, TN

Lisa Coco, NP, Certified Diabetes Educator

LISA COCO | NP

Certified Diabetes Educator
Jefferson University Physicians
Philadelphia, PA

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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 now 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
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
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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
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MECHANISM OF ACTION

GLP-1 RA therapy:

Signals the pancreas

  • To release the body’s own insulin, if blood sugar is high4,5
  • 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

tertiary_msg

“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

“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

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.
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

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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®

AEs >/=5% in SUSTAIN 4 trial

The AEs occurring in ≥5% of participants in SUSTAIN 4 taking Lantus® (n=360), Ozempic® 0.5 mg (n=362), and Ozempic® 1 mg (n=360), respectively, were:

Nausea (4%, 21%, 22%)
Diarrhea (4%, 16%, 19%)
Nasopharyngitis (12%, 12%, 8%)
Lipase increased (4%, 10%, 8%)
Decreased appetite (<1%, 7%, 6%)
Vomiting (3%, 7%, 10%)
Headache (6%, 5%, 6%)
Dyspepsia (1%, 3%, 7%)
Back pain (2%, 3%, 5%)
Gastro-esophageal reflux disease (1%, 1%, 5%)

GI AEs leading to treatment discontinuation (0%, 3%, 5%)6

AEs=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

  • 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 trials.2

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

AEs=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

"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

“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 at Week 30.

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Selected Important Safety Information

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 (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®.

Ozempic® (semaglutide) injection 0.5 mg or 1 mg 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-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 (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.
  • 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 click here for Prescribing Information, including Boxed Warning.

 

References:

  1. American Diabetes Association. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes—2019. Diabetes Care. 2019;42(Suppl.1):S90-S102.
  2. Ozempic [package insert]. Plainsboro, NJ: Novo Nordisk Inc; April 2019.
  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.