Superior weight reduction in head-to-head studies1,2

Ozempic® is not indicated for weight loss. Ozempic® is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. Body weight reduction was a secondary endpoint in clinical trials.    

In patients on metformin, for each dose comparison

Ozempic® demonstrated superior body weight reduction vs Trulicity®2

Secondary endpoint: Mean body weight change from baseline at Week 40

Ozempic® 0.5mg vs Trulicity 0.75mg weight results
Ozempic® 1mg vs Trulicity 1.5mg weight results

Baseline: 211 lb

Baseline: 213 lb

Ozempic® 0.5mg vs Trulicity 0.75mg weight results
Trulicity®
0.75 mg
Ozempic®
0.5 mg

n=299

n=301

Baseline: 206 lb

Baseline: 211 lb

Ozempic® 1mg vs Trulicity 1.5mg weight results
Trulicity®
1.5 mg
Ozempic®
1 mg

n=299

n=300

Ozempic® vs Trulicity weight study results

Ozempic® is not indicated for weight loss.  

Results based on a sensitivity analysis of retrieved dropout population: aestimated mean.


Results are from a 40-week randomized, open-label, active controlled trial in 1201 adult patients with type 2 diabetes comparing Ozempic® 0.5 mg to Trulicity® 0.75 mg and Ozempic® 1 mg to Trulicity® 1.5 mg.2

Adverse events (AEs) occurring in ≥5% of participants in SUSTAIN 72
SUSTAIN 7 was not designed to evaluate relative safety between Ozempic® and Trulicity®    

Ozempic® AEs ≥5% in SUSTAIN 7 trial
  • The AEs occurring in ≥5% of participants in SUSTAIN 7 taking Trulicity® 0.75 mg (n=299), Ozempic® 0.5 mg (n=301), Trulicity® 1.5 mg (n=299), and Ozempic® 1 mg (n=300), respectively, were: nausea (13%, 23%, 20%, 21%), diarrhea (8%, 14%, 18%, 14%), vomiting (4%, 10%, 10%, 10%), decreased appetite (3%, 8%, 10%, 9%), headache (4%, 8%, 6%, 7%), lipase increased (5%, 7%, 6%, 6%), nasopharyngitis (6%, 5%, 7%, 5%), upper respiratory tract infection (7%, 5%, 5%, 3%), constipation (3%, 5%, 5%, 5%), and GI AEs leading to discontinuation (2%, 5%, 5%, 6%)2
  • In placebo-controlled trials, the most common adverse reactions reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation1
  • 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 practice1
  • Comparator adverse event rates are not an adequate basis for comparison of safety between products

Ozempic® was studied head-to-head for glycemic control1,2

Ozempic® also had superior weight reduction vs Januvia® and Bydureon®1

Help patients realize the potential with Ozempic®

Help patients realize the potential with Ozempic®

Evaluated in a 2-year CVOT1


Once-weekly dosing

CVOT=cardiovascular outcomes trial.

STUDY DESIGNS

SUSTAIN 7: Head-to-head vs Trulicity® (dulaglutide)2

Study design: 40-week, multinational, multicenter, randomized, open-label, 4-armed, pair-wise, active-controlled, parallel-group trial to compare 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% at Week 40.

SUSTAIN 2: Head-to-head vs Januvia® (sitagliptin)3

Study design: 56-week, randomized, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic® vs sitagliptin.

Patients: A total of 1231 adult patients were randomized to receive once-weekly Ozempic® 0.5 mg (n=409), once-weekly Ozempic® 1 mg (n=409), or once-daily sitagliptin 100 mg (n=407), all in combination with metformin (94%) and/or thiazolidinediones (6%).

Primary endpoint: Mean change in A1C from baseline at Week 56.

Secondary endpoints: Mean change in body weight from baseline at Week 56; proportion of patients achieving A1C <7% at Week 56.

SUSTAIN 3: Head-to-head vs Bydureon® (exenatide ER)4

Study design: 56-week, randomized, open-label, active-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic® vs exenatide ER.

Patients: A total of 813 patients with type 2 diabetes on metformin alone (49%), metformin with sulfonylurea (45%), or others (6%) were randomized to receive once-weekly Ozempic® 1 mg (n=404) or exenatide 2 mg (n=405). All treatment arms were in combination with metformin or metformin and sulfonylurea.

Primary endpoint: Mean change in A1C from baseline at Week 56.

Secondary endpoints: Mean change in body weight from baseline at Week 56; proportion of patients achieving A1C <7% at Week 56.

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. Ozempic [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2017.
  2. 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. doi:10.1016/S2213-8587(18)30024-X. Epub 2018 Jan 31.
  3. Ahrén B, Masmiquel L, Kumar H, et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomized trial. Lancet Diabetes Endocrinol. 2017;5(5):341-354.
  4. Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): a 56-week, open-label, randomized clinical trial. Diabetes Care. 2018 Feb;41(2):258-266. doi:10.2337/dc17-0417. Epub 2017 Dec 15.