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Ozempic®—the once-weekly injectable with unmatched glycemic control across trials

Superior results vs Trulicity® and as add-on to basal insulin and statistically significant results vs study-titrated Lantus®1,2

Ozempic® vs Trulicity®

Unmatched A1C reductions vs Trulicity®2

In adult patients with type 2 diabetes on metformin
Primary endpoint: 
Mean change in A1C from baseline at Week 402,3

Ozempic® vs Trulicity A1C reductions

Results based on a sensitivity 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

Ozempic® delivered superior A1C control vs Trulicity®2

In adult patients with type 2 diabetes on metformin
Secondary endpoint: 
Percent of patients who achieved A1C <7% at Week 402,3

SUSTAIN 7 A1C control study results

Predefined secondary endpoint based on a post 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

Adverse events ≥5% in SUSTAIN 7
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
primary_msg

Body weight change was studied as a secondary endpoint

Ozempic® is not indicated for weight loss.

secondary_msg

Ozempic® vs Lantus®

Greater A1C reductions shown vs study‑titrated Lantus®, delivered in a once-weekly injection1

In insulin-naïve adult patients with type 2 diabetes on metformin ± sulfonylurea
Primary endpoint: Mean change in A1C from baseline at Week 301,3,4

Results based on a sensitivity analysis of retrieved dropout population.

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 insulin-naïve adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and Ozempic® 1 mg with Lantus®.1,4

Ozempic® delivered greater A1C control vs study‑titrated Lantus®1,4

In insulin-naïve adult patients with type 2 diabetes on metformin ± sulfonylurea
Secondary endpoint:
Percent of patients who achieved A1C <7% at Week 301,3,4

SUSTAIN 4 A1C control study results

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

Predefined secondary endpoint based on a post hoc analysis of retrieved dropout population.

Results are from a 30-week, randomized, open-label, active-controlled trial in 1089 insulin-naïve adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and Ozempic® 1 mg with Lantus®.1,4

Ozempic® lowered FPG and PPG1,3,4

In insulin-naïve adult patients with type 2 diabetes on metformin ± sulfonylurea
Secondary endpoint:
Mean change in FPG at Week 301,3,4,a

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

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 based on a post hoc analysis of retrieved dropout population.

aThe clinical relevance of FPG and PPG is unknown.
bBased 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.4

Results are from a 30-week, randomized, open-label, active-controlled trial in 1089 insulin-naïve adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and Ozempic® 1 mg with Lantus®.1,4

Adverse events ≥5% in SUSTAIN 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), 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 trials1
  • 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

Ozempic® has once-weekly dosing

tertiary_msg

Ozempic® as an add-on to basal insulin

Intensify with Ozempic® when patients are not getting the glycemic results they need from basal insulin1

In adult patients with type 2 diabetes on basal insulin ± metformin
Primary endpoint:
 Mean change in A1C from baseline at Week 301,3,5

Results based on a sensitivity analysis of retrieved dropout population.

Ozempic® as an add-on to basal insulin A1C reductions

Patients with A1C ≤8% at screening had their background basal insulin dose reduced by 20% at the start of the trial to limit potential risk of hypoglycemia.

Results are from a 30-week, randomized, double-blind, placebo-controlled, parallel-group trial in 397 adult patients with type 2 diabetes evaluating the addition of Ozempic® 0.5 mg and Ozempic® 1 mg to basal insulin ± metformin.1,5

Ozempic® as an add-on to basal insulin ± MET delivered superior A1C control vs basal insulin ± MET alone1

In adult patients with type 2 diabetes on basal insulin ± metformin
Secondary endpoint: Percent of patients who achieved A1C <7% at Week 301,3,5

Patients with A1C ≤8% at screening had their background basal insulin dose reduced by 20% at the start of the trial to limit potential risk of hypoglycemia.

Results based on post hoc analysis of retrieved dropout population.

Results are from a 30-week, randomized, double-blind, placebo-controlled, parallel-group trial in 397 adult patients with type 2 diabetes evaluating the addition of Ozempic® 0.5 mg and Ozempic® 1 mg to basal insulin ± metformin.1,5

When basal insulin ± metformin was not enough in adult patients with type 2 diabetes

Adding Ozempic® lowered both fasting and postmeal blood sugar1,3

Secondary endpoint: Mean change in FPG at Week 301,a

Mean change in PPG at Week 303,b

SUSTAIN 5 FPG and PPG reductions

Patients with A1C ≤8% at screening had their background basal insulin dose reduced by 20% at the start of the trial to limit potential risk of hypoglycemia.

The clinical relevance of FPG and PPG is unknown.

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

bMean change in 90-minute PPG from baseline at Week 30 was not a predefined endpoint. Post hoc analysis of absolute PPG means were calculated from the 7-point SMPG profile.

Results are from a 30-week, randomized, double-blind, placebo-controlled, parallel-group trial in 397 adult patients with type 2 diabetes evaluating the addition of Ozempic® 0.5 mg and Ozempic® 1 mg to basal insulin ± metformin.1,5

Adverse events ≥5% in SUSTAIN 5
AEs occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 53,5

AEs >/= 5% in SUSTAIN 5 trial

The AEs occurring in ≥5% of participants in SUSTAIN 5 taking placebo + basal insulin ± MET (n=133), Ozempic® 0.5 mg + basal insulin ± MET (n=132), and Ozempic® 1 mg + basal insulin ± MET (n=131), respectively, were:

Nausea (5%, 12%, 17%)
Vomiting (3%, 6%, 12%)
Diarrhea (2%, 5%, 7%)
Nasopharyngitis (11%, 8%, 5%)
Urinary tract infection (6%, 2%, 3%)
Upper respiratory tract infection (3%, 6%, <1%)
Lipase increased (3%, 9%, 5%)
Decreased appetite (<1%, 4%, 5%)

GI AEs leading to discontinuation (<1%, 5%, 6%)5

AE=adverse events; GI=gastrointestinal, MET=metformin.

  • Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled trials1
  • Incidence of severe hypoglycemia or blood glucose-confirmed hypoglycemia (% of patients) was5:
    • 8.3% with Ozempic® 0.5 mg + basal insulin ± metformin
    • 10.7% with Ozempic® 1 mg + basal insulin ± metformin
    • 5.3% with placebo + basal insulin ± metformin
  • The risk of hypoglycemia is increased when Ozempic® is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin1

Help patients realize the potential with Ozempic®

Help patients realize the potential with Ozempic®

Learn how Ozempic® works in the body to affect insulin response


Once-weekly dosing

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 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 5: As add-on to basal insulin vs placebo5

Study design: 30-week, randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic® in combination with basal insulin vs volume-matched placebo in combination with basal insulin.

Patients: A total of 397 adult patients inadequately controlled on basal insulin with or without metformin were randomized to once-weekly Ozempic® 0.5 mg (n=132), Ozempic® 1 mg (n=131), or placebo (n=133). Randomization was stratified according to A1C at screening. Patients with A1C ≤8% at screening reduced the insulin dose by 20% at start of trial to reduce the risk of hypoglycemia.

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

Secondary endpoints: Mean change in body weight from baseline at Week 30; proportion of patients achieving A1C <7% at Week 30; change in mean fasting plasma glucose (FPG) 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 (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. 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. Data on file. Novo Nordisk Inc., Plainsboro, NJ.
  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. Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomised, controlled trial. J Clin Endocrinol Metab. 2018;103(6):2291-2301.