Once-weekly Ozempic® mechanism of action

GLP-1 RA stimulates the body’s own insulin secretion

GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. Ozempic® acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.1

How Ozempic® works in the body:

Ozempic stimulates insulin secretion and lowers glucagon secretion

Stimulates insulin secretion

Ozempic® lowers fasting and postprandial blood glucose by stimulating insulin secretion in a glucose-dependent manner. With Ozempic®, the insulin secretion rate in patients with type 2 diabetes was similar to that of healthy subjects.1,2

See study design below.

Ozempic stimulates insulin secretion and lowers glucagon secretion

Lowers glucagon secretion

Ozempic® lowers glucagon secretion in a glucose-dependent manner.1

Ozempic delays gastric emptying

Minor delay in gastric emptying

Ozempic® causes a minor delay in gastric emptying, thereby reducing the rate at which glucose appears in circulation postprandially.1

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Ozempic® is a GLP‑1 analogue with 94% sequence homology to human GLP‑11

Structural modifications of the Ozempic® molecule result in decreased renal clearance and protection from metabolic degradation.1

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Ozempic® delivers week long coverage

Ozempic® delivers weeklong coverage1

~7 days | Elimination half-life of ~7 days.

Steady-state plasma concentrations icon

4 to 5 weeks

Steady-state plasma concentrations achieved following 4 to 5 weeks of once-weekly administration.    

In a pharmacodynamic study

Ozempic® provided similar insulin response to people without type 2 diabetes1,2

Insulin response to a graded glucose infusion test at 12 weeks1,2,a

aA continuous glucose infusion was adjusted over a 3-hour period to achieve target glucose levels from 90 to 216 mg/dL, increasing by increments of 18 mg/dL every 25 minutes.

Study design:

A 12-week, single-center, randomized, double-blind, placebo-controlled, parallel-group trial in 75 adult patients with type 2 diabetes. To examine the effects of Ozempic® 1 mg on different aspects of beta-cell response, primarily first- and second-phase insulin secretion, with a secretion rate as evaluated by a graded glucose infusion test, as a secondary endpoint. A comparator group of healthy participants (who did not receive treatment) was included in the study.2

Results:

With Ozempic®, the insulin secretion rate with type 2 diabetes was similar to that of healthy subjects.2

Ozempic® is dosed once weekly

Ozempic® has gradual dose escalation designed to help patients adjust to therapy.1,a Patients should administer Ozempic® once weekly with or without meals.

View dosing information »

Ozempic® dosing

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Help patients realize the potential with Ozempic®

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Help patients realize the potential with Ozempic®

Check your patients' coverage and co-pay for Ozempic®

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Learn about glycemic control with Ozempic®

Ozempic® has proven glycemic control when compared to Lantus1

View A1C results »

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 (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®.

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 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 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 (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®.

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 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: The risk of hypoglycemia is increased when Ozempic® is used in combination with insulin secretagogues (eg, 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 (eg, 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.

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. Ozempic [package insert]. Plainsboro, NJ: Novo Nordisk Inc; January 2020.
  2. Kapitza C, Dahl K, Jacobsen JB, Axelsen MD, Flint A. Effects of semaglutide on beta cell function and glycemic control in participants with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Diabetologia. 2017;60(8):1390-1399.

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