For adult patients with type 2 diabetes, along with diet and exercise to improve glycemic control
For adults with T2D and established CVD, to reduce risk of MACE1,b
Start early. Choose Ozempic® as your first injectable.
Discover the Tri-Zone with the power of 3
In adults with T2D and atherosclerotic cardiovascular disease
Ozempic® is not indicated for weight loss
Scroll below for Limitations of Use
cWeight change was a secondary endpoint in clinical trials.
T2D=type 2 diabetes.
Learn more about the Ozempic® Tri-Zone
Ozempic® significantly reduced risk of MACE1
As evaluated in SUSTAIN 6, a 2-year CVOT vs placebo in adults with T2D and established CVD. The primary composite endpoint was time from randomization to first occurrence of MACE (CV death, nonfatal MI, or nonfatal stroke).
CV=cardiovascular; CVD=cardiovascular disease; CVOT=cardiovascular outcome trial; MACE=major adverse cardiovascular event; MI=myocardial infarction.
Ozempic® achieved superior A1C reductions2,3,a,b
A1C control is in reach. A range of T2D patients saw A1C reductions across SUSTAIN 7 and SUSTAIN FORTE clinical trials.
aSUSTAIN 7: A 40-week, randomized, open-label, active-controlled trial in 1201 adult patients with type 2 diabetes on metformin, comparing Ozempic® 0.5 mg with Trulicity® 0.75 mg and Ozempic® 1.0 mg with Trulicity® 1.5 mg.2
bSUSTAIN FORTE: A 40-week, randomized, active-controlled trial in 961 adult patients with type 2 diabetes on metformin with or without a sulfonylurea, comparing Ozempic® 1 mg with Ozempic® 2 mg.3
Compelling weight loss across doses with Ozempic®2,3
As a secondary endpoint, patients with T2D saw compelling weight loss in the SUSTAIN 7 and SUSTAIN FORTE clinical trials.
Ozempic® is not indicated for weight loss.
Dosing options for a range of patients
Help your patients who need glycemic control get more from Ozempic®. View Ozempic® dosing to learn more.
Experience matters—yours and your patients’ with T2D
Learn more about Ozempic®.
#1
Prescribed
branded diabetes medication for new prescriptions in the USa
5.9
Million
patients prescribed worldwidea
5+
Years
helping patients with T2D
aSource: IQVIA XPD NBRx for the period starting on 2/11/2023 through 8/11/2023 comparing Ozempic® to other currently marketed branded diabetes prescription medications; new prescriptions are defined as new-to-brand prescriptions (NBRx), represents the number of patients starting a branded diabetes prescription medication who have not previously used the product in the last 12 months.
Study Designs
SUSTAIN 7:
Head-to-head vs Trulicity® (dulaglutide)2
Study design: 40-week, multinational, multicenter, randomized, open-label, 4-armed, pairwise, active-controlled, parallel-group trial evaluated the efficacy and safety of Ozempic® vs dulaglutide.
Patients: 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.
Primary endpoint: Mean change in A1C from baseline at Week 40.
Secondary endpoints: Mean change in body weight from baseline at Week 40; proportion of patients achieving A1C <7.0% at Week 40.
SUSTAIN FORTE:
Ozempic® 1 mg vs 2 mg3
Study design: 40-week, randomized, active-controlled, parallel-group, double-blind, phase 3B efficacy and safety trial of Ozempic® 2 mg vs Ozempic® 1 mg in patients with type 2 diabetes in need of treatment intensification.
Patients: A total of 961 adult patients with inadequately controlled type 2 diabetes (A1C 8.0%-10.0%) on metformin with or without a sulfonylurea were randomized 1:1 to 2 mg (n=480) or 1 mg (n=481) of once-weekly Ozempic®.
Primary endpoint: Mean change in A1C from baseline at Week 40.
Secondary endpoints: Mean change in body weight from baseline at Week 40; proportion of patients achieving A1C <7.0% at Week 40.
SUSTAIN 6:
2-year CVOT for Ozempic®1,4,5
Study design: A 104-week, multicenter, multinational, placebo-controlled, double-blind CVOT in 3297 adult patients with inadequately controlled type 2 diabetes and atherosclerotic cardiovascular disease. Patients had a mean duration of diabetes of 13.9 years, a mean baseline A1C of 8.7%, and 58% were taking insulin.
Patients: 3297 patients with A1C ≥7%, previously on 0 to 2 OADs ± basal or premixed insulin, ≥50 years of age, and established cardiovascular death risk OR ≥60 years of age with at least 1 CV risk factor were randomized to receive Ozempic® 0.5 mg (n=826), Ozempic® 1 mg (n=822), or placebo (n=1649), all in addition to standard of care treatments for diabetes and CVD such as oral antidiabetic treatments, insulin, antihypertensives, diuretics, lipid-lowering therapies, and antithrombotic medications at investigator's discretion.
Primary composite outcome: Time from randomization to first occurrence of 3-part composite MACE: CV death, nonfatal MI, and nonfatal stroke.
OAD=oral anti-diabetic drugs.
More ways to help your patients with T2D
Important Safety Information for Ozempic® (semaglutide) injection
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, 1 mg, or 2 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 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.
- Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients treated with Ozempic® 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
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:
- Ozempic® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Pratley RE, Aroda VR, Lingvay I, et al; on behalf of the SUSTAIN 7 investigators. 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.
- Frías JP, Auerbach P, Bajaj HS, et al. Efficacy and safety of once-weekly semaglutide 2.0 mg versus 1.0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial. Lancet Diabetes Endocrinol. 2021;9(9):563-574. doi: 10.1016/S2213-8587(21)00174-1
- 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. doi:10.1056/NEJMoa1607141
- Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. (supplemental appendix) N Engl J Med. 2016;375(19):1834-1844. doi:10.1056/NEJMoa1607141