In a head-to-head study vs Januvia® plus metformin, adults with type 2 diabetes experienced 2X greater A1C reductions when switched from Januvia® to Victoza®.1


Victoza® may help your uncontrolled Januvia® (sitagliptin) patients reach an A1C goal of <7% with the additional benefit of weight loss.1


A1C reduction from baseline at 26 weeks1


Chart comparing type 2 diabetes medications: Head-to-head study Januvia® plus metformin vs Victoza® in lowering A1C

Patients with type 2 diabetes in this study were inadequately controlled on metformin (≥1500 mg/day) and sitagliptin (100 mg/day), a dipeptidyl peptidase-4 inhibitor (DPP-4 i), for at least 90 days prior to screening (N=407). They were randomly switched to once-daily Victoza® 1.8 mg plus a Januvia® placebo (n=202) or continued Januvia® 100 mg plus a Victoza® placebo (n=204), both in combination with metformin. 

aP<0.0001 vs Januvia®.


In adults with type 2 diabetes

89% more patients reached A1C <7% with Victoza® at 26 weeks

Diabetes drugs: Januvia® vs Victoza® in reaching A1C <7% goal on metformin

103% difference in weight loss from mean baseline 198 lbs at 26 weeks

Diabetes drugs: Januvia® vs Victoza® in reaching A1C <7% goal on metformin

Victoza® is not indicated for chronic weight management, and weight change was a secondary endpoint in clinical trials.


Safety and tolerability were studied

The adverse events most commonly reported in ≥5% of patients treated with Victoza® 1.8 mg vs Januvia® 100 mg, both in combination with metformin, were nausea (21.8% vs 7.8%), diarrhea (16.3% vs 9.3%), decreased appetite (8.9% vs 3.4%), vomiting (7.4% vs 4.9%), headache (6.4% vs 5.9%),  nasopharyngytis (5.9% vs 3.4%), and increased lipase (5.5% vs 4.4%).1



Victoza® provided 3-for-1 benefits

In a 26-week head-to-head study vs Januvia®, Victoza® provided the benefit of significant A1C reductions with the additional benefits of weight change and a low rate of hypoglycemia in adults with type 2 diabetes taking metformin. Victoza® is not indicated for chronic weight management, and weight change was a secondary endpoint in clinical trials. 




Darla type 2 diabetes patient who is treated with Victoza®


“Victoza® has been a wonderful addition to my management of type 2 diabetes.”


Darla, Retired Air Force
Real Victoza® patient

Individual results may vary.



Get to know Victoza®


Unsurpassed A1C reductions

Across multiple studies, Victoza® was unsurpassed in reducing A1C in adults with type 2 diabetes.

bVictoza® is not indicated for chronic weight management, and weight change was a secondary endpoint in clinical trials.

 

 

Study design

A 26-week, randomized, parallel group, double-blind, double-dummy, active-controlled study to compare efficacy and safety in patients switching from sitagliptin (100 mg/day) to Victoza® 1.8 mg with patients who stayed on sitagliptin (100 mg/day). Patients with type 2 diabetes inadequately controlled on metformin (≥1500 mg/day) and sitagliptin (100 mg/day) for at least 90 days prior to screening (N=407) were randomized 1:1 to switch to once-daily Victoza® 1.8 mg plus a sitagliptin placebo or continued sitagliptin 100 mg plus a Victoza® placebo, both in combination with metformin.1


References: 1. Bailey TS, Takács R, Tinahones FJ, et al. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH™): a randomized, double-blind, double-dummy, active-controlled 26-week trial [published online ahead of print July 6, 2016]. Diabetes Obes Metab. doi:10.1111/dom.12736.0.

Selected Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

  • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Victoza® 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 Victoza® 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 Victoza®.

Indication and Limitations of Use

Victoza® (liraglutide) injection 1.2 mg or 1.8 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, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established CV disease.

  • Victoza® is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
  • Concurrent use with prandial insulin has not been studied.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

  • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Victoza® 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 Victoza® 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 Victoza®.

Contraindications

  • Victoza® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Victoza®.

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 pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza® postmarketing. 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 Victoza® promptly and if pancreatitis is confirmed, do not restart. Victoza® has been studied in a limited number of patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at a higher risk for development of pancreatitis on Victoza®.
  • Never Share a Victoza® Pen Between Patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
  • Hypoglycemia: When Victoza® is used with an insulin secretagogue (eg, a sulfonylurea) or insulin, serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
  • Renal Impairment: Acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, have been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (eg, anaphylaxis and angioedema) have been reported post-marketing. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza®; treat promptly per standard of care, and monitor until signs and symptoms resolve.  Do not use in patients with a previous hypersensitivity reaction to Victoza®. Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists.  Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-receptor agonist because it is unknown whether such patients will be predisposed to these reactions with Victoza®.
  • Acute Gallbladder Disease: In the LEADER trial, 3.1% of Victoza® vs. 1.9% of placebo-treated patients reported an acute event of gallbladder disease, such as cholelithiasis or cholecystitis. The majority of events required hospitalization or cholecystectomy. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow up are indicated.

Adverse Reactions

  • The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are nausea, diarrhea, headache, vomiting, decreased appetite, dyspepsia, and constipation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

Drug Interactions

  • Victoza® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Victoza®.

Use in Specific Populations

  • Victoza® has not been studied in patients with type 2 diabetes below 18 years of age and is not recommended for use in pediatric patients.
  • Victoza® slows gastric emptying. Victoza® has not been studied in patients with pre-existing gastroparesis.
  • Victoza® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Additional Important Safety Information

In 5 placebo-controlled clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 8 Victoza®-treated patients (7.5 events per 1000 patient-years). Of these 8 Victoza®-treated patients, 7 patients were concomitantly using a sulfonylurea.

In the pool of 5 placebo-controlled clinical trials, withdrawals due to gastrointestinal adverse reactions occurred in 4.3% of Victoza®- treated patients and 0.5% of placebo-treated patients. Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2 to 3 months of the trials.

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