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Superior weight reduction vs Trulicity®, vs Bydureon®, and vs SGLT-2i ± MET/SU alone1-3

And statistically significant weight reduction vs Lantus® based on study protocol titration1,4

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 change in body weight from baseline at Week 40

Ozempic® is not indicated for weight loss.  

Ozempic® vs Trulicity® study results - weight

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

primary_msg

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

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%)

GI AEs leading to discontinuation (2%, 5%, 5%, 6%)2

AE=adverse events; GI=gastrointestinal.
  • 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

In patients on 1 or more OADs

Ozempic® demonstrated superior body weight reduction vs Bydureon®1,5

Secondary endpoint: Mean change in body weight from baseline at Week 56

Ozempic® is not indicated for weight loss.  

Ozempic® vs Bydureon® study results - weight

Results are from a 56-week, randomized, double-blind, active-controlled trial in 813 patients with type 2 diabetes.1,4

AEs occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 35
SUSTAIN 3 was not designed to evaluate relative safety between Ozempic® and Bydureon®

AEs >/= 5% in SUSTAIN 3 trial

The AEs occurring in ≥5% of participants in SUSTAIN 3 taking Bydureon® 2 mg (n=405) and Ozempic® 1 mg (n=404), respectively, were:

Nausea (11.9%, 22.3%)
Diarrhea (8.4%, 11.4%)
Lipase increased (12.1%, 10.1%)
Nasopharyngitis (9.4%, 9.7%)
Headache (9.6%, 9.4%)
Decreased appetite (5.2%, 7.9%)
Vomiting (6.2%, 7.2%)
Dyspepsia (4.7%, 6.7%)
Constipation (5.2%, 6.4%)
Injection site nodule (12.1%, 0%)

GI AEs leading to treatment discontinuation (2.7%, 5.7%)4

AE=adverse events; GI=gastrointestinal.
  • 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

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®1,4

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

Ozempic® is not indicated for weight loss.  

Ozempic® vs Lantus® study results - weight

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®.1,4

AEs occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 44
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 discontinuation (0%, 3%, 5%)4

AE=adverse events; GI=gastrointestinal.
  • 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
  • Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled trials.1
  • 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®.4,a

aDefined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions or blood glucose-confirmed symptomatic hypoglycemia (plasma glucose ≤3.1 mmol/L [56 mg/dL].4

Results from a 30-week, randomized, open-label, active-controlled trial in 1089 adult, insulin-naïve patients with type 2 diabetes.1,4

In patients on SGLT‑2i with or without metformin/sulfonyurea

Adding Ozempic® provided superior weight reduction vs SGLT-2i ± MET/SU alone3

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

Ozempic® is not indicated for weight loss.  

Ozempic® with SGLT-2i study results - weight

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

Results are from a 30-week, randomized, double-blind, active-controlled trial in 302 adult patients with type 2 diabetes comparing Ozempic® 1 mg to existing SGLT-2i ± MET/SU.3

SGLT-2i=sodium-glucose contransporter-2 inhibitor; MET=metformin; SU=sulfonylurea; ETD=estimated treatment difference; CI=confidence interval.

Adverse Events ≥5% in SUSTAIN 9
AEs occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 93

AEs >/= 5% in SUSTAIN 9 trial

The AEs occurring in ≥5% of participants in SUSTAIN 9 taking Placebo + SGLT-2i ± MET/SU (n=151) and Ozempic® 1 mg + SGLT-2i ± MET/SU (n=150), respectively, were:

Nausea (3.3%, 19.3%)
Diarrhea (6.0%, 11.3%)
Vomiting (2.0%, 9.3%)
Constipation (0%, 6.7%)

GI AEs leading to discontinuation (0%, 6.7%)

AE=adverse events; MET=metformin; GI=gastrointestinal; SGLT-2i=sodium-glucose cotransporter inhibitor; SU=sulfonylurea.

  • 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
  • Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled trials.1
  • Incidence of hypoglycemia (% of patients) was 11.3% with Ozempic® 1 mg + SGLT-2i ± MET/SU and 2.0% with placebo + SGLT-2i ± MET/SU3,a

aAmerican Diabetes Association classified, including hypoglycemia episodes classified as severe, documented symptomatic, asymptomatic, probable symptomatic, and pseudo-hypoglycemia.

secondary_msg

Hear expert insight on how Ozempic® outperformed Trulicity® in weight change in the SUSTAIN 7 trial

Ozempic® is not indicated for weight loss and change in weight was evaluated as a secondary endpoint.

Help patients realize the potential with Ozempic®

Help patients realize the potential with Ozempic®

Ozempic® has proven glycemic control1


Evaluated in a 2-year CVOT1

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; change in mean fasting plasma glucose (FPG) at Week 40; change in PPG increment (difference between the postprandial and preprandial glucose values across the 3 main meals from a 7-point self-measured plasma glucose (SMPG) profile at Week 40).

SUSTAIN 3: Head-to-head vs Bydureon® (exenatide ER)1,5

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.

SUSTAIN 4: Head-to-head vs Lantus® (insulin glargine U-100)1,4

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 endpoints: Mean change in body weight at Week 30; proportion of patients achieving A1C <7% at Week 30; change in mean fasting plasma glucose (FPG) at Week 30; change in PPG increment (difference between the postprandial and preprandial glucose values across the 3 main meals from an 8-point self-measured plasma glucose (SMPG) profile at Week 30).

SUSTAIN 9: Ozempic® as add-on to SGLT‑2i ± MET/SU3

Study design: 30-week, multinational, randomized, double-blind, parallel-group, placebo-controlled trial comparing the efficacy and safety of adding Ozempic® 1 mg to SGLT-2i ± metformin/sulfonylurea vs SGLT-2i + placebo ± metformin/sulfonylurea. Patients were on SGLT-2i for an average of approximately 46 weeks at randomization.6

Patients: A total of 302 adult patients with type 2 diabetes inadequately controlled on SGLT-2i ± metformin/sulfonylurea were randomized to receive Ozempic® 1 mg (n=151) once weekly or volume-matched placebo (n=151) as an add-on to SGLT-2i ± metformin/sulfonylurea.

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

Secondary endpoints: Mean change in body weight at Week 30; proportion of patients achieving A1C <7% at Week 30; change in mean fasting plasma glucose (FPG) at Week 30; change in PPG increment—defined as the difference between the postprandial glucose and preprandial glucose values across the 3 main meals from a 7-point SMPG (self-measured plasma glucose) profile.

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. 2018;6(4):275-286.
  3. Zinman B, Bhosekar V, Busch R, et al. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomized placebo-controlled trial. [published online March 1, 2019] Lancet Diabetes Endocrinol. doi.org/10.1016/S2213-8587(19)30066-X.
  4. 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.
  5. 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;41(2):258-266.
  6. Data on file. Novo Nordisk Inc., Plainsboro, NJ.