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Victoza (Liraglutide) - Summary

 
 



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 human relevance could not be ruled out by clinical or nonclinical studies. 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). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [ see Contraindications (4), Warnings and Precautions and Nonclinical Toxicology].

 

VICTOZA SUMMARY

Victoza contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor.

Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use

  • Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
  • In clinical trials of Victoza, there were more cases of pancreatitis with Victoza than with comparators. Victoza has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza. Use with caution in patients with a history of pancreatitis.
  • Victoza is not a substitute for insulin. Victoza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
  • The concurrent use of Victoza and insulin has not been studied.

See all Victoza indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Victoza (Liraglutide)

Diabetes Drug Victoza May Help the Heart: Study
Source: MedicineNet glucagon Specialty [2016.06.15]
Title: Diabetes Drug Victoza May Help the Heart: Study
Category: Health News
Created: 6/14/2016 12:00:00 AM
Last Editorial Review: 6/15/2016 12:00:00 AM

more news >>

Published Studies Related to Victoza (Liraglutide)

Liraglutide promotes natriuresis but does not increase circulating levels of atrial natriuretic peptide in hypertensive subjects with type 2 diabetes. [2015]
CONCLUSIONS: Sustained liraglutide administration for 3 weeks increases urinary

Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. [2013]
diabetes mellitus (T2DM)... CONCLUSIONS: LEADER commenced in September 2010, and enrollment concluded in

Liraglutide: a review of its use in the management of type 2 diabetes mellitus. [2011.12.03]
Liraglutide (Victoza(R)) is a subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist produced by recombinant DNA technology and used as an adjunct to diet and exercise in the treatment of adults with type 2 diabetes mellitus. This article reviews the clinical efficacy and tolerability of liraglutide in adults with type 2 diabetes, and provides a summary of its pharmacological properties...

The Pharmacokinetics, Pharmacodynamics, and Tolerability of Liraglutide, a Once-Daily Human GLP-1 Analogue, After Multiple Subcutaneous Administration in Healthy Chinese Male Subjects. [2011.12]
In this single-center, randomized, double-blind, within dose group, placebo-controlled, dose escalation trial, the pharmacokinetics, pharmacodynamics, tolerability, and safety of liraglutide were evaluated in 37 healthy Chinese subjects. Subjects were randomized to 1 of 3 dose groups (0.6, 1.2, or 1.8 mg), and within each group, randomized to liraglutide or placebo (3:1)...

Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. [2011.08.16]
Objective:Having demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.Design:A randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/investigators at 1 year) in 19 European clinical research centers.Subjects:A total of 564 adults (n=90-98 per group; body mass index 30-40 kg m(-2)) enrolled, 398 entered the extension and 268 completed the 2-year trial...

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Clinical Trials Related to Victoza (Liraglutide)

Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI [Completed]
The main purpose of this study is to help us understand the effects of diabetes medication Liraglutide on weight loss and hunger. The investigators have already determined what the highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide was approved by the FDA in January 2010 for treatment of diabetes. The investigators will also study the following: 1. The impact of Liraglutide on brain responses to food 2. It's effect on physiological and mental performance 3. If its effect on the brain differs among obese and lean diabetic subjects.

Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study [Recruiting]
Exploratory, double-blind randomized, placebo-controlled, Phase II study to evaluate the effect(s) of short-term administration of liraglutide, a GLP-1R (glucagon-like peptide-1 receptor) agonist on joint and skin inflammation in patients with active Psoriatic Arthritis.

The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes [Active, not recruiting]
It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.

Blood Pressure Outcomes With Liraglutide Therapy [Completed]
Purpose: The purpose of this study is to further study the mechanism by which liraglutide, a relatively new anti-hyperglycemic medication, might lower blood pressure in patients with Type 2 diabetes and high blood pressure.

Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients [Completed]
Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy. We hypothesise that this is also the case in humans. This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients. Impact on basic kidney physiological will be determined and kidney injury markers will be measured as surrogate parameters of kidney protection.

more trials >>

Reports of Suspected Victoza (Liraglutide) Side Effects

Nausea (686)Blood Glucose Increased (317)Decreased Appetite (266)Pancreatitis (247)Diarrhoea (245)Weight Decreased (241)Vomiting (236)Pancreatitis Acute (165)Headache (146)Constipation (125)more >>


Page last updated: 2016-06-15

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