Across 7 clinical trials, 70% of adult patients with type 2 diabetes lost some weight with Victoza®.1

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

LEAD 4 vs metformin + TZD2

Zinman:
Victoza® + metformin + TZD vs metformin + TZD

Victoza® 1.8 mg (n=178)
Victoza® 1.2 mg (n=177)

placebo (n=175)

Baseline weight 209 lb to 217 lb

Liraglutide weight change vs metformin plus TZD
 

Pratley (1860) vs sitagliptin3

Pratley (1860):
Victoza® + metformin vs sitagliptin + metformin

Victoza® 1.8 mg (n=218)
Victoza® 1.2 mg (n=221)

sitagliptin 100 mg (n=219)

Baseline weight 207 lb

Weight change with liraglutide vs sitagliptin
 

LEAD 1 vs TZD4

Marre:
Victoza® + SU vs TZD + SU

Victoza® 1.8 mg (n=234)
Victoza® 1.2 mg (n=228)

rosiglitazone 4 mg (n=232)
placebo (n=114)

Baseline weight 176 lb to 183 lb

Victoza® weight change clinical trial vs TZD
 

LEAD 2 vs glimepiride5

Nauck:
Victoza® + metformin vs glimepiride + metformin

Victoza® 1.8 mg (n=242)
Victoza® 1.2 mg (n=240)

glimepiride 4 mg (n=242)
placebo (n=121)

Baseline weight 194 lb to 200 lb

Weight change with Victoza® vs glimepiride
 

LEAD 6 vs exenatide6

Buse:
Victoza® + metformin and/or SU vs exenatide + metformin and/or SU

Victoza® 1.8 mg (n=233)

exenatide 10 µg twice daily (n=231)

Baseline weight 205 lb

 
Victoza® weight change clinical trial vs TZD
 
 

A1C reductions

 

Victoza® 1.8 mg (n=233):-1.1a,b

exenatide 10 µg twice daily (n=231): -0.8

Baseline A1C 8.1% to 8.2%

aP<0.0001 vs comparator.6

bETD Victoza® 1.8 mg vs exenatide 10 µg twice daily: -0.3%; 95% CI (-0.5 to -0.2).6

LEAD 6 extension7

Buse:
Patients on Victoza® remained on Victoza® + OADs. Patients on exenatine switched to Victoza® and continued on OADs.

Continued on Victoza® 1.8 mg (n=202)
Patients on Victoza® remained on Victoza® + OADs
 
 

A1C reductions

 

Continued on Victoza® 1.8 mg (n=202): -0.1

Switch from exenatide 10 µg twice daily to Victoza® 1.8 mg (n=187)
Patients on exenatine switched to Victoza® and continued on OADs
 

A1C reductions

 
Switch from exenatide 10 µg twice daily to Victoza® 1.8 mg (n=187): -0.3c

Baseline A1C 7.0% to 7.2%

cP<0.0001 from week 26 to week 40.7

 

Victoza® + metformin provided reductions of up to 17% in visceral fat.8

 

Safety and tolerability were studied

LEAD 4


LEAD 4

Nausea was transient.2
No major hypoglycemic events occurred.2
Low rate of minor hypoglycemia with Victoza®.2

Pratley (1860)


Pratley (1860)

Nausea occurred more frequently with Victoza® but was transient, and the percentage of patients reporting it declined over time.3

LEAD 1


LEAD 1

Hypoglycemia was infrequent with all treatments.4

LEAD 2


LEAD 2

Nausea was transient.5
No major hypoglycemic events occurred.5
Low rate of minor hypoglycemia compared with glimepiride.5

LEAD 6


LEAD 6

Nausea resolved more quickly in patients treated with Victoza® than in those treated with exenatide.6

Low rate of hypoglycemia compared to exenatide.6

LEAD 6 extension


LEAD 6 extension

Lower rate of minor hypoglycemia when switched from exenatide in comparison to the rate with exenatide at week 26.7

 


Discover the benefits of Victoza®


Tighter glycemic control

Victoza® provides improved A1C control with daily management of FPG and PPG.

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Study designs

LEAD 4
A 26-week, double-blind, placebo-controlled, parallel-group, multicenter study to compare the efficacy and safety of Victoza® in combination with rosiglitazone + metformin vs rosiglitazone + metformin. Patients with type 2 diabetes (N=533) were randomized to receive once-daily Victoza® 1.2 mg (n=178), Victoza® 1.8 mg (n=178), or placebo (n=177). The primary outcome was change in A1C.2

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.3

LEAD 1
A 26-week, double-blind, double-dummy, placebo- and active-controlled, 5-armed, parallel trial to compare the efficacy and safety of Victoza®, rosiglitazone, and placebo, all in combination with glimepiride, in type 2 diabetes. Patients with type 2 diabetes (N=1041) were randomized to receive once-daily Victoza® 0.6 mg (n=233), Victoza® 1.2 mg (n=228), Victoza® 1.8 mg (n=234), rosiglitazone 4 mga (n=232), or placebo (n=114) in combination with glimepiride (2-4 mg). The primary outcome was change in A1C.4

LEAD 2
A 26-week, double-blind, double-dummy, placebo- and active-controlled, parallel-group, randomized trial to compare the safety and efficacy of Victoza®, glimepiride, and placebo, all in combination with metformin. Patients with type 2 diabetes (N=1091) were randomized to receive Victoza® 0.6 mg (n=242), Victoza® 1.2 mg (n=241), Victoza® 1.8 mg (n=242), glimepiride 4 mga (n=244), or placebo (n=122). The primary endpoint was change in A1C.5

 

LEAD 6
A 26-week, open-label, active-comparator, parallel-group, multicenter study to compare the safety and efficacy of Victoza® with exenatide in patients not adequately controlled on metformin or sulfonylurea or both. Patients with type 2 diabetes (N=464) were stratified by previous oral antidiabetic therapy and randomized to receive once-daily Victoza® 1.8 mg (n=233) or exenatide 10 µg BID (n=231) in combination with metformin and/or sulfonylurea. The primary outcome was change in A1C.6

LEAD 6 extension
A 14-week, non-randomized, extension study of LEAD 6. Patients with type 2 diabetes (N=389) continued on once-daily Victoza® 1.8 mg (n=202) or switched from exenatide 10 µg BID to once-daily Victoza® 1.8 mg (n=187) in combination with metformin and/or sulfonylurea. All 389 patients who completed 26 weeks entered the extension study, with 376/389 (97%) completing 40 weeks.7

 


a4 mg=half the maximal approved dose in the United States.
SU=sulfonylurea; TZD=thiazolidinedione.


References: 1. Niswender K, Pi-Sunyer X, Buse J, et al. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013;15(1):42-54. 2. Zinman B, Gerich J, Buse JB, et al; for the LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009;32(7):1224-1230. 3. 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. 4. Marre M, Shaw J, Brändle M, et al; on behalf of the LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabet Med. 2009;26(3):268-278. 5. Nauck M, Frid A, Hermansen K, et al; for the LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009;32(1):84-90. 6. Buse JB, Rosenstock J, Sesti G, et al; for the LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009;374(9683):39-47. 7. Buse JB, Sesti G, Schmidt WE, et al. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010;33(6):1300-1303. 8. Jendle J, Nauck MA, Matthews DR, et al; for the LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009;11(12):1163-1172.

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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