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Ozempic® demonstrated superior A1C reductions vs Trulicity® and Bydureon®1,2

And statistically significant A1C reductions vs Lantus® based on study protocol titration1,3

Ozempic® vs Trulicity®

In patients on metformin, for each dose comparison

Ozempic® outperformed Trulicity® in reducing A1C2

Primary endpoint: Mean change in A1C from baseline at Week 40

Ozempic® vs Trulicity A1C reductions

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

In patients on metformin, for each dose comparison

Ozempic® delivered superior A1C control vs Trulicity®2

Secondary endpoint: Percent of patients who achieved A1C <7% at Week 40

SUSTAIN 7 A1C control study results

Predefined secondary endpoint analyzed using post ad hoc analysis of retrieved dropout population.

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

In patients on metformin

Reductions in FPG and PPG increment2,4

Secondary endpoint: Mean change in FPG at Week 40b

Secondary endpoint: Mean change in PPG increment at Week 40b,c

Predefined secondary endpoint analyzed using post hoc analysis of retrieved dropout population; not adjusted for multiplicity.

bThe clinical relevance of FPG and PPG is unknown.
cBased on the 7-point self-measured plasma glucose (SMPG) profile, PPG increment is the overall mean difference between the postprandial glucose and the preprandial glucose overall values across the 3 main meals.2

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

AEs occurring in ≥5% of participants 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
Learn about weight results with Ozempic®

Body weight change was studied as a secondary endpoint

Ozempic® is not indicated for weight loss.

Ozempic® vs Bydureon®

In patients on 1 or more OADs

Ozempic® outperformed Bydureon® in reducing A1C1,5

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

Results are from a 56-week randomized, double-blind, active-controlled trial in 813 adult patients with type 2 diabetes.1,5

In patients on 1 or more OADs

Ozempic® delivered superior A1C control vs Bydureon®1

Secondary endpoint: Percent of patients achieving A1C <7% at Week 56

Results are from a 56-week randomized, double-blind, active-controlled trial in 813 adult patients with type 2 diabetes.1,5

secondary_msg

AEs occurring in ≥5% of participants 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%)5

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

Ozempic® vs Lantus®

Based on study protocol insulin titration, in insulin-naïve patients on metformin with or without sulfonylurea

Ozempic® demonstrated statistically significant A1C reductions vs Lantus®1,3

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

Ozempic® vs Lantus A1C reductions

26% of insulin patients titrated to goal by Week 30. Mean daily insulin dose: 29 U/day.1

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®.1,3

Based on study protocol insulin titration, in insulin-naïve patients on metformin with or without sulfonylurea

Ozempic® delivered greater A1C control vs Lantus®1,5

Secondary endpoint: Percent of patients who achieved A1C <7% at Week 30

SUSTAIN 4 A1C control study results

26% of insulin patients titrated to goal by Week 30. Mean daily insulin dose: 29 U/day.1

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®.1,3

Based on study protocol insulin titration, in insulin-naïve patients on metformin with or without sulfonylurea

Ozempic® lowered FPG and PPG1,3,4

Secondary endpoint: Mean change in FPG at Week 30b

Secondary endpoint: Mean change in PPG increment at Week 30b,d

SUSTAIN 4 FPG and PPG increment reductions

26% of insulin patients titrated to goal by Week 30. Mean daily insulin dose: 29 U/day.1

Predefined secondary endpoint analyzed using post ad hoc analysis of retrieved dropout population.

bThe clinical relevance of FPG and PPG is unknown.
dBased on the 8-point self-measured plasma glucose (SMPG) profile, PPG increment is the overall mean difference between the postprandial glucose and the preprandial glucose overall values across the 3 main meals.3

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®.1,3

tertiary_msg

AEs occurring in ≥5% of participants in SUSTAIN 43
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 7 taking Lantus® (n=360), Ozempic® 0.5 mg (n=362), 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%)
Upper respiratory tract infection (7%, 3%, 4%)
Gastro-esophageal reflux disease (1%, 1%, 5%)

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

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®.3

quaternary_msg

Help patients realize the potential with Ozempic®

Help patients realize the potential with Ozempic®

Evaluated in a 2-year CVOT1


Once-weekly dosing

Ozempic® is not indicated for reduction in major adverse cardiovascular events (MACE).

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)1,3

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).

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. 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.
  4. Data on file. Novo Nordisk Inc., Plainsboro, NJ.
  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.