What is it?

Zomarist is a medicine that contains the active substances vildagliptin and metformin hydrochloride. It is available as oval tablets (light yellow: 50 mg vildagliptin and 850 mg metformin hydrochloride; dark yellow: 50 mg vildagliptin and 1,000 mg metformin hydrochloride).

This medicine is the same as Eucreas, which is already authorised in the European Union (EU). The company that makes Eucreas has agreed that its scientific data can be used for Zomarist.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Zomarist is used to treat type 2 diabetes. It is used in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Zomarist is one tablet twice a day, with one tablet taken in the morning and one in the evening. The choice of tablet strength to start with depends on the dose of metformin the patient is currently taking, but the recommended dose is 50 mg vildagliptin and 1,000 mg metformin twice a day. Patients already taking vildagliptin and metformin should switch to Zomarist containing the same amounts of each active substance. Doses of vildagliptin above 100 mg are not recommended.

Taking Zomarist with or just after food may reduce any stomach problems caused by metformin. Zomarist should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver. Elderly patients taking Zomarist should have their kidney function monitored regularly.

How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. Zomarist contains two active substances, which each have a different mode of action. Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ?incretin? hormones in the body.

These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut. As a result of the action of both substances, the blood glucose is reduced and this helps to control type 2 diabetes.

How has it been studied?

Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. The studies of Galvus as an add-on to metformin were used to support the use of Zomarist in the same indication. The studies measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

The applicant also presented the results of two studies showing that the active substances in the two strengths of Zomarist were absorbed in the body in the same way as when they were taken as separate tablets.

What benefits has it shown during the studies?

Vildagliptin was more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin. Patients adding vildagliptin had a fall in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%. In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of 8.30%.

What is the risk associated?

The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite. For the full list of all side effects reported with Zomarist, see the package leaflet.

Zomarist should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients. It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack. It must also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast-feeding. For the full list of restrictions, see the package leaflet.

Why has it been approved?

The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment. Therefore, the Committee decided that the benefits of Zomarist are greater than its risks and recommended that it be given marketing authorisation.

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