Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist. Victoza is the first once-daily injection and the only GLP-1 analog with 97% homology to natural GLP-1. Victoza stimulates beta cells to release insulin in the presence of elevated glucose concentrations and it also involves a delay in gastric emptying.  Once euglycemia is reached the release of insulin subsides.

Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus along with selected other diabetes medications.  Victoza is not recommended as initial therapy for patients who have inadequate glycemic control on diet and exercise alone.  Victoza should also not be used to treat type 1 diabetes mellitus or diabetic ketoacidosis and has not been studied in combination with insulin.

Important safety concerns are associated with the use of Victoza.  A boxed-warning regarding the risk of thyroid C-cell tumors is included with the prescribing information.  In animal studies, dose-dependent and treatment-duration-dependent thyroid C-cell tumors developed in rats and mice.  Some tumors were cancerous and the rate of these cancerous tumors significantly increased in rats receiving doses of Victoza 8-times higher than what humans would receive.  Not being able to rule out the possibility of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans during clinical trials, Victoza is contraindicated in patients who have a personal or family history MTC and in patients who have Multiple Endocrine Neoplasia syndrome type 2.  Another safety concern of Victoza is the development of pancreatitis.  Of the more than 3,900 people who participated in the five clinical trials there were seven cases of pancreatitis among the treatment (Victoza) group and one case in a patient who was using another diabetes medication.  The most common adverse effects reported during the clinical trials included headache, nausea, diarrhea and antiliraglutide antibody formation, which may develop into urticaria. 

The FDA approved Victoza with post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA).  The requirements include a cardiovascular study to evaluate the effects Victoza has in a higher risk population, conduct a 5-year epidemiological study to evaluate thyroid and other cancer risks as well as risks for hypoglycemia, pancreatitis, and allergic reactions.  Another requirement is to establish a cancer registry to monitor the rate of medullary thyroid cancer in the United States over the next 15 years.  The FDA is also requiring a Risk Evaluation and Mitigation Strategy (REMS) that will include a medication guide and a communication plan for physicians.

Effectiveness and safety of Victoza was demonstrated in five clinical trials that involved over 3,900 people. Victoza was effective in reducing the A1C by 1.0% - 1.5% at a dose of 1.8mg and when used in combination with metformin a weight reduction of 6.2 pounds was also seen.

Victoza is administered as a once-daily subcutaneous injection in the abdomen, thigh or upper arm without regard to meals.  Patients will start out at 0.6mg, which is not effective for glycemic control, for one week to reduce gastrointestinal symptoms.  After the first week the dose will be increased to 1.2mg.  The dose may ultimately be increased to 1.8mg.

Victoza is approved in the European Union, Mexico, Iceland and Japan.

Victoza will be available in the United States beginning February 22 to March 8, 2010.

The complete FDA News Release may be found here.

Questions and Answers - Safety Requirements for Victoza (liraglutide) may be found here.

Novo Nordisk’s Press Release may be found here.

Website for Victoza may be found here.

Full prescribing information for Victoza may be found here.