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Trajenta Approved for Treating Type II Diabetes


Trajenta is a medicine that contains the active substance linagliptin. It is available as tablets (5 mg). Trajenta is used to treat type 2 diabetes mellitus. It is used together with metformin, or together with metformin and a sulphonylurea, when blood sugar is not already adequately controlled by diet, exercise and these antidiabetes medicines.

 

It is also used on its own in patients whose blood sugar is not adequately controlled by diet and exercise alone and who cannot be treated with metformin because they cannot tolerate it or because they have kidney problems.
The medicine can only be obtained with a prescription.
The recommended dose of Trajenta is one tablet once a day with or without food. When added to metformin the dose of metformin should remain unchanged, however when combined with a sulphonylurea, a lower dose of the sulphonylurea may be considered because of the risk of hypoglycaemia (low blood sugar).
The effects of Trajenta were first tested in experimental models before being studied in humans.
 
Four main studies in patients with type 2 diabetes were carried out with Trajenta, comparing the medicine with placebo (a dummy treatment) in combination with metformin (701 patients), in combination with metformin plus a sulphonylurea (1,058 patients) and in combination with another antidiabetes medicine pioglitazone (389 patients). Trajenta was also compared with placebo when used on its own in 503 patients.
 
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment. This gives an indication of how well blood glucose is controlled.
Trajenta was shown to be more effective than placebo at reducing HbA1c levels in all combinations studied: a reduction of 0.56 points compared with a rise of 0.10 points in combination with metformin; a reduction of 0.72 points compared with 0.10 points in combination with a metformin plus a sulphonylurea; and a reduction of 1.25 percentage points compared with 0.75 points in combination with pioglitazone.
 
Trajenta was also more effective than placebo when used on its own, reducing HbA1c levels by 0.46 points compared with a rise of 0.22 points seen with placebo.
Results from studies comparing Trajenta with placebo show that the overall risk of side effects were similar: 54% versus 55%. The most frequently reported side effect, seen in around 5% of patients taking Trajenta, was hypoglycaemia. Most cases were mild and none were severe. Hypoglycaemia was seen in around 15% of patients treated with the triple combination of Trajenta with metformin and a sulphonylurea (around twice as many as the placebo group). For the full list of all side effects reported with Trajenta, see the package leaflet.
 
Trajenta must not be used in people who are hypersensitive (allergic) to linagliptin or to any of the other ingredients.
Based on the results of the main studies, the CHMP concluded that significant benefits in controlling blood glucose levels were seen in the combinations of Trajenta with metformin and with metformin plus a sulphonylurea. Trajenta on its own was also shown to be effective compared with placebo and was considered appropriate for patients who cannot take metformin either due to intolerance or because they have kidney problems. However the benefit of adding Trajenta to pioglitazone treatment was not considered to have been sufficiently established.
 
The overall risk of side effects with Trajenta was mostly comparable to placebo and the medicine’s safety is similar to that of other dipeptidyl peptidase 4 (DPP-4) inhibitor medicines.
 
The Committee therefore concluded that the benefits of Trajenta outweigh its risks and recommended that it be granted marketing authorisation.
 
 

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Prepared by: Scientific Section


Source :

 

European Medicines Agency 






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