Victoza® provided 3-for-1 benefits in a 26-week study vs sitagliptin in adults with type 2 diabetes.


At 26 weeks added on to metformin:


Victoza®: lowering A1C levels in type 2 diabetes patients

A1C reduction1

On average from baseline 8.4% to 8.5%

-1.5% Victoza® 1.8 mga
-1.2% Victoza® 1.2 mga

-0.9% sitagliptin 100 mg

aP<0.0001 vs sitagliptin.




Pound icon

Weight lossb

On average from mean baseline 207 lb

-7.3 lb Victoza® 1.8 mgb
-5.9 lb Victoza® 1.2 mgb

-1.8 lb sitagliptin 100 mg

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



Shield icon with a cross

Low rate of minor hypoglycemia1,c

One incident of major hypoglycemia was reported.

c5% of patients across all study arms experienced minor hypoglycemia. One incident of major hypoglycemia was reported in the Victoza® 1.2 mg group.1



Safety and tolerability
Safety Tolerability chart
Safety and Tolerability chart


After 52 weeks vs sitagliptin as an add-on to metformin

Victoza® provided sustained benefits to more patients.

In the 26-week study with a 26-week extension2



Sustained A1C reductions after 1 year.
Victoza® showed sustained benefits in lowering A1C levels in type 2 diabetes patients


Weight loss sustained for 1 year2,b
Weight icon

-8.1 lb Victoza® 1.8 mg
-6.1 lb Victoza® 1.2 mg
-2.6 lb sitagliptin 100 mg

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

Low rate of minor hypoglycemia over 1 year2,d
Icon of a shield with a cross

8.3% Victoza® 1.8 mg
8.1% Victoza® 1.2 mg
6.4% sitagliptin 100 mg

dOne incident of major hypoglycemia was reported in the Victoza® 1.2 mg group in the first 26 weeks.2



Victoza® composite endpoint

Percentage of patients reaching all 3 efficacy and safety components of composite endpoint2:




Victoza® clinical benefits
A1C <7.0%

No weight gainb

No confirmed major or minor hypoglycemiad

Safety and tolerability were studied

Safety and Tolerability chart
Safety and Tolerability chart


bVictoza® is not indicated for chronic weight management, and weight change was a secondary endpoint in clinical trials.
dOne incident of major hypoglycemia was reported in the Victoza® 1.2 mg group in the first 26 weeks.2


Video: Victoza® goes head-to-head with sitagliptin

In this video, Richard E. Pratley, MD, presents the results of a head-to-head study comparing the efficacy and safety of Victoza® with sitagliptin, both in combination with metformin.


Victoza® vs Januvia®, a Head-to-Head Comparison

  1. Pratley RE, Nauck M, Bailey T, et al; for the 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010;375(9724):1447-1456.
  2. Pratley RE, Nauck M, Bailey T, et al; for the 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011;65(4):397-407.



Get to know Victoza®


Victoza® MOA video
See the effects of Victoza® in multiple systems.





Find out more about 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 designs

Pratley
Pratley (1860): A 26-week, open-label, active-comparator, 3-armed, parallel-group trial to compare the efficacy and safety of Victoza® with sitagliptin for the treatment of type 2 diabetes. Patients with type 2 diabetes inadequately controlled on metformin (N=665) were randomized to receive once-daily Victoza® 1.2 mg (n=225), Victoza® 1.8 mg (n=221), or sitagliptin 100 mg (n=219). The primary outcome was change in A1C.1
 

Pratley Extension
A 26-week, open-label extension study of Pratley (1860). Patients with type 2 diabetes (N=497) continued on Victoza® 1.2 mg (n=155), Victoza® 1.8 mg (n=176), or sitagliptin 100 mg (n=166) following a 26-week, active-comparator, 3-armed, parallel-group study. The primary outcome of the open-label extension was change in A1C from baseline after 52 weeks. Of participants completing 26 weeks, 497/554 (90%) entered the extension, with 436/497 (88%) completing 52 weeks.2

References: 1. Pratley RE, Nauck M, Bailey T, et al; for the 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010;375(9724):1447-1456. 2. Pratley R, Nauck M, Bailey T, et al; for the 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011;65(4):397-407.

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.

Please click here for Prescribing Information.