Victoza - liraglutide

What is Victoza?

Victoza is a solution for injection containing the active substance liraglutide, available in pre-filled pens (6 mg / ml).

What is Victoza used for?

Victoza is indicated for adult patients with type 2 diabetes (non-insulin-dependent diabetes) to control the level of glucose (sugar) in the blood. Victoza is used in combination with:

• metformin or a sulphonylurea (antidiabetic medicines), in patients with insufficient glycemic control despite the maximum tolerated dose of metformin or sulphonylurea in monotherapy;

• metformin and a sulphonylurea or metformin and a thiazolidinedione (another group of antidiabetic medicines) in patients with insufficient glycemic control despite therapy with two drugs.

The medicine can only be obtained with a prescription

How is Victoza used?

Victoza is given once a day and can be injected subcutaneously (under the skin) in the abdomen, thigh or upper arm. The medicine can be taken at any time, regardless of meals, preferably at the same time each day.

The initial dose of Victoza is 0.6 mg. After at least a week, the dose should be increased to 1.2 mg. For some patients, the dose may still be increased to 1.8 mg, after a further week, to achieve better control of blood glucose levels.

In those cases where Victoza is added to the current metformin or thiazolidinedone based therapy, it is not necessary to vary the doses of these medicines. If instead Victoza is added to a treatment with a sulphonylurea, it will be up to the doctor to decide whether or not to lower the dose of sulphonylurea in order to reduce the risk of hypoglycemia (low blood sugar).

How does Victoza work?

Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active ingredient in Victoza, liraglutide, is an "incretino-mimetic": it works in a similar way to incretins (hormones produced in the intestine) by increasing the amount of insulin released by the pancreas in response to food. This helps keep blood glucose levels under control.

How has Victoza been studied?

The effects of Victoza were first tested in experimental models before being studied in humans.

The medicine was analyzed in five main studies involving 3 978 adults with type 2 diabetes, namely:

• a 'monotherapy' study that compared Victoza, given alone, with glimepiride (a sulphonylurea);

• two "dual therapy" studies comparing Victoza in combination with metformin or Victoza in combination with glimepiride with metformin or glimepiride taken with a placebo (a dummy treatment);

• two studies in "triple therapy" that compared Victoza in combination with metformin and glimepiride or rosiglitazone (a thiazolidinedione), with treatments that included a placebo or another antidiabetic medicine instead of Victoza.

The main indicator of effectiveness was the change in the amount of a substance present in the blood called glycosylated hemoglobin (HbA1c) after six months or one year. HbA1c offers an indication of the degree of glucose control in the blood.

What benefit has Victoza shown during the studies?

The combinations comprising Victoza have been shown to be more effective in controlling blood glucose than the combinations in which the medicine did not appear. The dual therapies, containing Victoza and metformin or a sulphonylurea have allowed HbA1c reductions of about 1%, while no reduction was recorded in the absence of Victoza. Therapy with three drugs including metformin and a sulphonylurea or a thiazolidinedione allowed a reduction of 1.3-1.5% compared to a reduction equal to or less than 0.5% without Victoza. In monotherapy, a greater HbA1c reduction was also observed with Victoza than with glimepiride. However, the study was not sufficient to support the use of Victoza alone.

What is the risk associated with Victoza?

The most common side effects seen with Victoza, used in combination with other antidiabetic medicines (in more than 1 patient in 10) are hypoglycaemia (low blood glucose), headache, nausea and diarrhea. For the full list of all side effects reported with Victoza, see the Package Leaflet.

Victoza should not be used in people who may be hypersensitive (allergic) to liraglutide or any of the other ingredients.

Why has Victoza been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Victoza's benefits are greater than its risks for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in dual therapy, in combination with metformin or a sulphonylurea, or in the three-drug therapy in combination with metformin and a sulphonylurea or a thiazolidinedione. The committee therefore recommended that Victoza be given marketing authorization.