In head-to-head studies, no GLP-1 receptor agonist has produced significantly greater A1C reductions or greater reductions in weight than once-daily Victoza®.1-3

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

Victoza® vs dulaglutide1,a


A1C reduction

(%) at 26 weeksb

Victoza® 1.8 mg (n=300)

dulaglutide 1.5 mg (n=299)

Baseline A1C 8.1%
 

Head-to-head study on  A1C reduction Victoza® vs. dulaglutide

Weight loss (lb) at 26 weeksc

Victoza® 1.8 mg (n=300)

dulaglutide 1.5 mg (n=299)

Baseline weight
206.4 lb to 207.7 lb

Victoza® vs. Dulaglutide in weight change


aStudy sponsored by Eli Lilly and Company.

bUpper limit of the 95% CI (-0.19; 0.07) was less than the prespecified noninferiority margin, establishing noninferiority.

cP=0.011.


 

Victoza® vs albiglutide2,d


A1C reduction

(%) at 32 weekse

Victoza® 1.8 mg (n=403)

albiglutide 50 mg (n=402)

Baseline A1C 8.2%

Head-to-head study on A1C Reduction Victoza® vs. Albiglutide

Weight loss (lb) at 32 weeksf

Victoza® 1.8 mg (n=403)

albiglutide 50 mg (n=402)

Baseline weight
201.7 lb to 204.2 lb

Victoza® vs. albiglutide in weight change


dStudy sponsored by GlaxoSmithKline.

eThe upper bound of the 95% CI (0.08; 0.34) did not meet noninferiority criteria.

fP<0.0001.


 

Victoza® vs exenatide ER3,g


A1C reduction

(%) at 26 weeksh

Victoza® 1.8 mg (n=450)

exenatide ER 2 mg (n=461)

Baseline A1C 8.4% to 8.5%

Head-to-head study on A1C reduction with Victoza® vs. exenatide ER

Weight loss (lb) at 26 weeksi

Victoza® 1.8 mg (n=450)

exenatide ER 2 mg (n=461)

Baseline weight 200 lb to 200.4 lb

Victoza® vs. exenatide ER in weight change


gStudy sponsored by Eli Lilly and Company and Amylin Pharmaceuticals LLC.

hThe upper bound of the 95% CI (0.08; 0.33) did not meet noninferiority criteria.

iP=0.005.


 

Safety and tolerability were studied

Victoza® 1.8 mg once daily vs dulaglutide 1.5 mg once weekly
The most common adverse events occurring in 5% or more of patients in the treatment groups combined (Victoza® 1.8 mg vs dulaglutide 1.5 mg): nausea (18% vs 20%); diarrhea (12% vs 12%); vomiting (8% vs 7%); dyspepsia (6% vs 8%); constipation (6% vs 4%); nasopharyngitis (7% vs 8%); headache (8% vs 7%); back pain (5% vs 4%); decreased appetite (7% vs 5%); and minor hypoglycemia (6% vs 9%). No major hypoglycemia occurred.1

Victoza® 1.8 mg once daily vs albiglutide 50 mg once weekly
The most common adverse events occurring in 5% or more of patients in the treatment groups combined (Victoza® 1.8 mg vs albiglutide 50 mg): diarrhea (14% vs 15%); upper respiratory tract infection (11% vs 10%); nausea (29% vs 10%); injection-site reaction (1% vs 7%); urinary tract infection (6% vs 6%); nasopharyngitis (7% vs 6%); increased lipase concentration (7% vs 5%); headache (5% vs 5%); vomiting (9% vs 5%); and minor hypoglycemia (13% vs 10%). No major hypoglycemia occurred.2

The HARMONY 7 trial vs albiglutide included data from the Pancreatitis Adjudication Committee2:

  • During the study itself, the Pancreatitis Adjudication Committee undertook masked adjudication of possible events of pancreatitis
  • Of these patients, 1 person in the albiglutide group and 2 in the Victoza® group were judged to have definite or probable pancreatitis that was at least possibly related to study treatment
  • The remaining cases were adjudicated as possible pancreatitis based on lipase elevation alone (11 albiglutide, 8 Victoza®) or unlikely (1 Victoza®)

Victoza® 1.8 mg once daily vs exenatide ER 2 mg once weekly
The most common adverse events occurring in 5% or more of patients in the treatment groups combined (Victoza® 1.8 mg vs exenatide ER 2 mg): nausea (21% vs 9%); diarrhea (13% vs 6%); headache (8% vs 6%); vomiting (11% vs 4%); nasopharyngitis (7% vs 7%); injection-site nodule (1% vs 10%); decreased appetite (6% vs 4%); constipation (5% vs 5%); dyspepsia (6% vs 2%); unexpected therapeutic response (6% vs 2%); and minor hypoglycemia in patients not taking concomitant sulfonylurea (3% vs 4%). No major hypoglycemia occurred.3

 

See how Victoza® may help your adult patients


Unsurpassed A1C reductions

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

 

Study designs

AWARD-6
A 26-week, randomized, open-label, parallel-group, multicenter (62 sites), multinational (9 countries), phase 3, noninferiority study. Patients were included based on the following criteria: adults with type 2 diabetes, treated with metformin, A1C of 7% to 10%, and a BMI of up to 45 kg/m2. Patients (N=599) were randomized to receive once-weekly dulaglutide 1.5 mg (n=299) or once-daily Victoza® 1.8 mg (n=300). The primary endpoint was change in A1C.1



HARMONY 7
A 32-week, randomized, open-label, parallel-group, multicenter (162 sites), multinational (8 countries), noninferiority, phase 3 study. Patients were included based on the following criteria: adults with type 2 diabetes, treated with lifestyle modification and oral antidiabetic drugs (metformin, rosiglitazone, sulfonylurea, or any combination of these drugs), A1C of 7% to 10%, and a BMI of 20 kg/m2 to 45 kg/m2. Adult patients with type 2 diabetes (N=841) were randomized to receive albiglutide 30 mg weekly, titrated to 50 mg weekly (n=422), or Victoza® 0.6 mg daily, titrated to 1.8 mg daily (n=419). The primary endpoint was change in A1C.2


DURATION-6
A 26-week, open-label, randomized, parallel-group, active-comparator, multicenter (105 sites), multinational (19 countries), noninferiority trial was conducted to compare the efficacy and safety of exenatide ER once weekly with Victoza® 1.8 mg once daily in adults with type 2 diabetes. Patients (N=911) were randomly assigned to receive once-daily Victoza® 1.8 mg (n=450) or once-weekly exenatide ER 2 mg (n=461) in addition to metformin, sulfonylurea, metformin + sulfonylurea, or metformin + pioglitazone. The primary endpoint was change in A1C.3  


ER=extended release; GLP-1=glucagon-like peptide-1.


References: 1. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. 2. Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014;2(4):289-297. 3. Buse JB, Nauck M, Forst T, et al. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013;381(9861):117-124. 

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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