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 diet, exercise and the antidiabetic medicines mentioned do not adequately control blood sugar.
Trajenta can be used on its own both in patients whose blood glucose cannot be adequately controlled with diet and exercise alone, 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 should remain unchanged; however, when used in combination with a sulphonylurea, a lower dose of sulphonylurea may be considered, due to the risk of hypoglycaemia (low blood sugar).
How does Trajenta - Linagliptin 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 where the body is unable to use insulin effectively. The active substance in Trajenta, linagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor, which works by inhibiting the breakdown of 'incretin' hormones in the body. These hormones are released after food 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 may also reduce the amount of glucose produced. from the liver, increasing insulin levels and reducing levels of the hormone glucagon. 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 tested in experimental models.
There are four main studies carried out on Trajenta in patients with type 2 diabetes. 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 placebo used alone in 503 patients.
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated hemoglobin (HbA1c) after a 24-week treatment period. This indicates how well the 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 combinations studied, thanks to a reduction of 0.56 points compared to a growth of 0.10 points in combination with metformin, a reduction by 0.72 points compared to 0.10 points in combination with a metformin and a sulphonylurea and, finally, a reduction of 1.25 percentage points from 0.75 points in combination with pioglitazone.
Used on its own, Trajenta showed greater efficacy than placebo, reducing HbA1c levels by 0.46 points compared to a 0.22 point increase seen with placebo.
What is the risk associated with Trajenta - Linagliptin?
The results of the studies comparing Trajenta with placebo show that the overall risks of side effects are similar, at a rate of 54% versus 55%. The most frequently reported undesirable effect observed in 5% of patients treated with Trajenta is hypoglycaemia. In most cases, this effect was minor but never severe. A 15% level of hypoglycaemia was found in patients treated with the triple combination therapy of Trajenta, metformin and a sulphonylurea (approximately double that of patients in the placebo group). For the full list of side effects reported with Trajenta, see the package leaflet.
Trajenta should not be used by people who are hypersensitive (allergic) to linagliptin or any of the other ingredients it contains.
Why has Trajenta - Linagliptin been approved?
Based on the results of the main studies, the CHMP concluded that the combination of Trajenta with metformin and metformin plus a sulphonylurea has significant benefits in controlling blood glucose levels. The use of Trajenta alone has also shown its effectiveness. 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 pioglitazone treatment have not been sufficiently demonstrated.
The overall risk of side effects of Trajenta is mostly comparable to that of placebo and the safety of the medicine is similar to that of other dipeptidyl peptidase 4 (DPP-4) inhibitor medicines.
Therefore, the CHMP decided that Trajenta's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
More information about Trajenta - Linagliptin
On 24 August 2011, the European Commission issued a "Marketing Authorization" for Trajenta, valid throughout the European Union.
For more information about Trajenta therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2011.
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