Once-daily Victoza® provides improved A1C control with daily management of FPG and PPG in adults with type 2 diabetes.1

Victoza® tighter glycemic control
 
Victoza® tighter glycemic control

aPPG was measured as a secondary endpoint in clinical studies. PPG data were obtained via self-monitoring of blood glucose.

 

In a 52-week study as monotherapy, once-daily Victoza® offered significant reductions in A1C1

A1C reductions (%)

Victoza® 1.8 mg (n=246)
Victoza® 1.2 mg (n=251)

glimepiride 8 mg (n=248)

bP<0.0001 vs glimepiride.
cP=0.0014 vs glimepiride.

A1C reduction study with Victoza®


Patients reaching A1C goal of <7% (%)d

Victoza® 1.8 mg
Victoza® 1.2 mg

glimepiride 8 mg

dADA A1C goal is <7%.

View Victoza® patient goals and results in A1C study


Victoza® provides daily management of FPG and PPG.

FPG reductions at 2 weeks, maintained for 52 weeks1


Graph outlining FPG reductions in type 2 diabetes patients using Victoza®
Graph outlining FPG reductions in type 2 diabetes patients using Victoza®

ADA FPG goal was 90-130 mg/dL at the time of trial design.1




PPG coverage throughout the day1
ADA PPG recommendation <180 mg/dL


View PPG coverage throughout the day in patients using Victoza®
View PPG coverage throughout the day in patients using Victoza®


 

eP=0.0038 compared with glimepiride.
fP=0.1616 compared with glimepiride.


Victoza® lowered premeal, postprandial, and fasting glucose throughout the day.
Glimepiride was studied, but is not shown in this graph.
PPG was measured as a secondary endpoint in clinical studies.
PPG data were obtained via self-monitoring of blood glucose.1

 


Safety and tolerability were studied

Daily Management - Safety and tolerability table
Daily Management - Safety and tolerability table
 



No major hypoglycemia events occurred.1



Chris' Victoza® testimony


Chris' Victoza® testimony

“I was very surprised when I took Victoza® at how well it integrated into my life. I get up every morning and it fits right into my schedule every day.


Chris, financial advisor
Real Victoza® patient


Individual results may vary.

 


Learn more about the benefits of Victoza®


Once daily vs once weekly

In head‐to‐head studies, no GLP‐1 receptor agonist has produced greater A1C reductions than Victoza®.

Patient resources

Programs and resources are available to help support your adult patients with type 2 diabetes.

 

Study design

LEAD 3
A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=746) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.1

ADA=American Diabetes Association; FPG=fasting plasma glucose; PPG=postprandial plasma glucose; GLP-1=glucagon-like peptide-1; RA=receptor agonist.


Reference: 1. Garber A, Henry R, Ratner R, et al; for the LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009;373(9662):473-481.

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.

  • Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
  • Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza® postmarketing. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®; consider other antidiabetic therapies for these patients.
  • 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 prior serious hypersensitivity reaction to Victoza® 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 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. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • 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 postmarketing. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and promptly seek medical advice.
  • Macrovascular Outcomes: There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

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, and vomiting. 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 preexisting gastroparesis.

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.

Please click here for Prescribing Information.