Trajenta - Linagliptin

What is Trajenta - Linagliptin?

Trajenta is a medicine that contains the active substance linagliptin. It is available as tablets (5 mg).

What is Trajenta - Linagliptin used for?

Trajenta is indicated for the treatment of type 2 diabetes mellitus. It can be used in combination with metformin or together with metformin and a sulphonylurea in cases where the diet, exercise and the antidiabetic medicines mentioned do not adequately control blood glucose.

Trajenta can be used on its own in patients whose blood sugar cannot be adequately controlled only with diet and exercise, and in patients who cannot be treated with metformin because they are intolerant to it or have kidney problems.

The medicine can only be obtained with a prescription.

How is Trajenta - Linagliptin used?

The recommended dose is one tablet a day with or without food. When added to metformin, the metformin dose must remain unchanged; however, when used in combination with a sulphonylurea, a lower dose of sulphonylurea may be considered, due to the risk of hypoglycemia (low blood sugar).

How does Trajenta - Linagliptin 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 where the body is unable to use insulin effectively. The active substance in Trajenta, linagliptin, is an inhibitor of dipeptidyl peptidase 4 (DPP-4), which works by inhibiting the degradation of "incretin" hormones in the body. These hormones are released after food intake and stimulate the pancreas in insulin production. By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. If the glucose level is low linagliptin does not work. Linagliptin can also reduce the amount of glucose produced by the liver, increasing insulin levels and reducing the levels of the glucagon hormone. Together, these processes reduce blood glucose levels and help control type 2 diabetes.

How has Trajenta - Linagliptin been studied?

Before being studied in humans, the effects of Trajenta were first analyzed in experimental models.

The main studies carried out on Trajenta and relating to patients with type 2 diabetes are four. Their purpose is to compare this medicine with placebo (a dummy treatment) in combination with metformin (701 patients), with metformin and a sulphonylurea (1 058 patients), as well as with another antidibetic medicine, pioglitazone (389 patients) . Trajenta was also compared with the placebo used on its own in 503 patients.

In all studies, the main efficacy parameter is the change in blood levels of a substance called glycosylated hemoglobin (HbA1c) after a 24-week treatment period. This indicates how well blood glucose is controlled.

What benefit has Trajenta - Linagliptin shown during the studies?

Trajenta was more effective than placebo in reducing HbA1c levels in all the combinations examined, thanks to a reduction of 0.56 points compared to a growth of 0.10 points in association with metformin, to a reduction of 0.72 points compared to 0.10 points in association with a metformin and a sulphonylurea and, finally, to a reduction of 1.25 percentage points compared to 0.75 points in association with pioglitazone.

Used as monotherapy, Trajenta showed greater efficacy than placebo, reducing HbA1c levels by 0.46 points compared to a growth of 0.22 points observed with placebo.

What is the risk associated with Trajenta - Linagliptin?

The results of studies comparing Trajenta with placebo show that the overall risks of undesirable effects are similar, reaching 54% against 55%. The most frequently reported undesirable effect in 5% of patients treated with Trajenta is hypoglycaemia. In most cases this effect proved to be minor, without ever being serious. A 15% hypoglycemia level was found in patients treated with Trajenta's triple combination therapy, metformin and a sulphonylurea (about double compared to patients in the placebo group). For the full list of all side effects reported with Trajenta, see the Package Leaflet.

Trajenta should not be used in people who are hypersensitive (allergic) to linagliptin or any of the other ingredients it contains.

Why has Trajenta - Linagliptin been approved?

Based on the findings of the main studies, the CHMP concluded that the combination of Trajenta with metformin and metformin plus a sulfonylurea has significant benefits in controlling blood glucose levels. Also the use of Trajenta in monotherapy has proved its efficacy compared to placebo and is considered adequate for patients who, being intolerant or suffering from kidney problems, cannot take metformin. However, the benefits of adding Trajenta to treatment with pioglitazone have not been sufficiently demonstrated.

The overall risk of the undesirable effects of Trajenta is mostly comparable to that of placebo and the safety of the medicine is similar to that of other drugs based on dipeptidyl peptidase 4 (DPP-4) inhibitors.

Therefore, the CHMP decided that Trajenta's benefits are greater than its risks and recommended that it be given marketing authorization.

More information on Trajenta - Linagliptin

On 24 August 2011, the European Commission issued a marketing authorization for Trajenta, valid throughout the European Union.

For more information on treatment with Trajenta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 07-2011.