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See why RYBELSUS® should be your choice vs Januvia®

Wondering why RYBELSUS® should be a go-to following metformin for your appropriate patients? In a head-to-head trial, the world's first and only oral GLP-1 RA delivered1:

Superior A1C reductions1,2

Up to 56% of patients achieving A1C <7%1,2

Superior reduction in body weight1,2

Explore the study results below, and see information on competitive commercial coverage.a,b

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

RYBELSUS® is not indicated for weight loss.

Rybelsus® vs Januvia®

RYBELSUS® vs Januvia®:

A1c reduction icon

Superior A1C reductions with RYBELSUS® 7 mg and 14 mg vs Januvia®1,2

Rybelsus® delivers 63% greater a1c reduction with 14mg
Rybelsus® 7mg and 14mg provides superior a1c reductions compared to Januvia®
secondary_msg

RYBELSUS® delivered significant results across key secondary endpoints:

A1c control icon

Superior A1C control (A1C <7%) with RYBELSUS® 14 mg and 7 mg vs Januvia®1,2

Secondary endpoints included:
Proportion of patients achieving A1C <7% at week 26.

Rybelsus® has superior a1c control compared to Januvia®
More patients achieved an a1c target of <7% with Rybelsus® vs Januvia®
primary_msg
Weight loss icon

Superior weight reductions with RYBELSUS® 14 mg and 7 mg vs Januvia®1,2

Confirmatory secondary endpoint:
Mean change in body weight from baseline to Week 26.

RYBELSUS® is not indicated for weight loss.

Rybelsus® has superior weight reduction compared to Januvia®

ETD=estimated treatment difference.

primary_msg
A1C control icon

Superior A1C control (A1C <7%) with RYBELSUS® 14 mg and 7 mg vs Januvia®1,2

Secondary endpoints included:
Proportion of patients achieving A1C <7% at Week 26.

Rybelsus® has superior a1c control compared to Januvia®
More patients achieved an a1c target of <7% with Rybelsus® vs Januvia®
Weight loss icon

Superior weight reductions with RYBELSUS® 14 mg and 7 mg vs Januvia®1,2

Confirmatory secondary endpoint:
Mean change in body weight from baseline to Week 26.

RYBELSUS® is not indicated for weight loss.

Rybelsus® has superior weight reduction compared to Januvia®

ETD=estimated treatment difference.

PIONEER 3 Study Design: RYBELSUS® vs Januvia®

Objective:

Compare treatment of RYBELSUS® to Januvia® for A1C reductions in adult patients with type 2 diabetes

double-blind

double-dummy

Patients

1864 adult patients with type 2 diabetes on metformin alone or metformin with a sulfonylurea

Median observation time was 26 weeks

Treatment Arms

Patients were randomized to RYBELSUS® 3 mg (n=466), RYBELSUS® 7 mg (n=465), RYBELSUS® 14 mg (n=465), or Januvia® 100 mg (n=467), all once daily.

In an a1c reduction trial, Rybelsus® had better results than Januvia®
Rybelsus® had better results than Januvia in an a1c reduction trial

Primary endpoint

Mean change in A1C from baseline to 26 weeks1,2

Confirmatory secondary endpoint

Mean change in body weight from baseline to Week 261,2

Select secondary endpoint

Proportion of patients achieving A1C <7% at Week 261,2

secondary_msg

Hypothetical patient

Meet Rachel: a patient with type 2 diabetes

Rachel has been taking metformin for years, but her A1C level continues to increase little by little.

Having seen the data, would adding RYBELSUS® be your choice for patients like Rachel?

Rachel a patient with type 2 diabetes
Meet Rachel a patient with type 2 diabetes

Patient profile

Patient profile with type 2 diabetes

RYBELSUS® has wider commercial coverage than Januvia®a,b


aCalculated with NIAD market volume (previously GLP-1) to prepare for Rybelsus access calculations. Note: Data from VANTAGE Fingertip Formulary bridge/February 2021 Nomenclature, and Xponent PlanTrak using week ending 3/05/2021; only considers bridged volume; excludes cash and mail order data; based on full DCS/EDCS/OCS IC universe (targets and non-targets). 
b
Novo Nordisk defines access as covered when brand is available on formulary with or without restrictions. Coverage status and tier vary by plan and are subject to change. Please check directly with the health plan to confirm coverage for individual patients.

Give your patients what they need to start with RYBELSUS®

Request a patient starter kit for your patients. Each kit includes savings information to help with the cost of their prescriptions.

RYBELSUS® Patient Starter Kit

You may also be interested in:

A1C & Weight Data »

FAQs »

Getting Updates »

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 RYBELSUS® 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
  • RYBELSUS® 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 RYBELSUS® 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 RYBELSUS®

Indications and Usage

RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Limitations of Use

  • RYBELSUS® 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
  • RYBELSUS® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis
  • RYBELSUS® is not indicated for use in patients with type 1 diabetes

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 RYBELSUS® 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
  • RYBELSUS® 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 RYBELSUS® 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 RYBELSUS®

Contraindications

  • RYBELSUS® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with RYBELSUS®

Warnings and Precautions

  • Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
  • Pancreatitis: Has been reported in clinical trials. Observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue RYBELSUS® and initiate appropriate management; if confirmed, do not restart RYBELSUS®
  • Diabetic Retinopathy Complications: In a pooled analysis of glycemic control trials with RYBELSUS®, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with RYBELSUS® and 3.8% with comparator). In a 2-year trial with semaglutide injection involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with semaglutide injection (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. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy
  • Hypoglycemia: Patients receiving RYBELSUS® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. 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, including semaglutide. 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 RYBELSUS® in patients reporting severe adverse gastrointestinal reactions
  • Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with RYBELSUS®. If hypersensitivity reactions occur, discontinue use of RYBELSUS®, 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 RYBELSUS® are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation

Drug Interactions

  • When initiating RYBELSUS®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia
  • RYBELSUS® delays gastric emptying and has the potential to impact the absorption of other oral medications. Closely follow RYBELSUS® administration instructions when coadministering with other oral medications and consider increased monitoring for medications with a narrow therapeutic index, such as levothyroxine

Use in Specific Populations

  • Pregnancy: Available data with RYBELSUS® are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to RYBELSUS®. Use only if the potential benefit justifies the potential risk to the fetus
  • Lactation: There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of salcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS®, from breastfeeding and because there are alternative formulations of semaglutide that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with RYBELSUS® 
  • Discontinue RYBELSUS® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
  • Pediatric Use: Safety and efficacy of RYBELSUS® have not been established in pediatric patients (younger than 18 years)

Please click here for Prescribing Information, including Boxed Warning.

References:

  1. RYBELSUS® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; April 2021.
  2. Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial. JAMA. 2019;321(15):1466-1480.