Trajenta
Active Substance: linagliptin
Common Name: linagliptin
ATC Code: A10BH05
Marketing Authorisation Holder: Boehringer Ingelheim International
GmbH
Active Substance: linagliptin
Status: Authorised
Authorisation Date: 2011-08-24
Therapeutic Area: Diabetes Mellitus, Type 2
Pharmacotherapeutic Group: Drugs used in diabetes
Therapeutic Indication
Trajenta is indicated in the treatment of type 2
diabetes mellitus to improve glycaemic control in adults:
as monotherapy
in patients inadequately controlled
by diet and exercise alone and for whom metformin is inappropriate due to
intolerance, or contraindicated due to renal impairment.
as combination
therapy
in combination with metformin when
diet and exercise plus metformin alone do not provide adequate glycaemic
control.in combination with a sulphonylurea
and metformin when diet and exercise plus dual therapy with these
medicinal products do not provide adequate glycaemic control.in combination with insulin with or
without metformin, when this regimen alone, with diet and exercise, does
not provide adequate glycaemic control.
What is Trajenta?
Trajenta is a medicine that contains the active
substance linagliptin. It is available as tablets (5 mg).
What is Trajenta used for?
Trajenta is used to treat type-2 diabetes with the
following antidiabetes medicines when blood sugar levels are not already
adequately controlled by diet, exercise and these antidiabetes medicines taken
alone:
metformin;metformin and a sulphonylurea;insulin, either on its own or
together with metformin.
Trajenta is also used on its own in patients whose
blood sugar levels are 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.
How is Trajenta used?
The recommended dose of Trajenta is one tablet once
a day. When added to metformin the dose of metformin should remain unchanged,
however when combined with a sulphonylurea or insulin, a lower dose of the
sulphonylurea or insulin may be considered because of the risk of hypoglycaemia
(low blood sugar).
How does Trajenta 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. The active
substance in Trajenta, linagliptin, is a dipeptidyl-peptidase-4 (DPP-4)
inhibitor. It 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 prolonging the action of incretin hormones in the blood,
linagliptin stimulates the pancreas to produce more insulin when blood glucose
levels are high. Linagliptin does not work when the blood glucose is low.
Linagliptin also reduces the amount of glucose made by the liver, by increasing
insulin levels and decreasing the levels of the hormone glucagon. Together,
these processes reduce blood glucose levels and help to control type-2
diabetes.
How has Trajenta been studied?
Five 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), in combination with another
antidiabetes medicine pioglitazone (389 patients) and in combination insulin
with or without metformin and/or pioglitazone (1235 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.
What benefit has Trajenta shown
during the studies?
Trajenta was shown to be more effective than
placebo at reducing HbA1c levels in all combinations studied:
when used in combination with
metformin, a reduction of 0.56 percentage points was seen with Trajenta
compared with a rise of 0.10 percentage points with placebo;when used in combination with a
metformin plus a sulphonylurea, a reduction of 0.72 percentage points was
seen with Trajenta compared with a reduction of 0.10 percentage points
with placebo;in combination with pioglitazone, a
reduction of 1.25 percentage points was seen with Trajenta compared with a
reduction of 0.75 percentage points with placebo;in combination with insulin with or
without metformin and / or pioglitazone, a reduction of 0.55 percentage
points was seen with Trajenta compared with a rise of 0.10 percentage
points with placebo.
Trajenta was also more effective than placebo when
used on its own, reducing HbA1c levels by 0.46 percentage points compared with
a rise of 0.22 percentage points seen with placebo.
What is the risk associated with
Trajenta?
Results from studies show that the overall risk of
side effects were similar between Trajenta and placebo (63% versus 60%). The
most frequently reported side effect, seen in around 6 out of 100 patients
taking Trajenta, was hypoglycaemia. Most cases were mild and none were severe.
Hypoglycaemia was seen in around 15 out of 100 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.
Why has Trajenta been approved?
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, with metformin plus a
sulphonylurea, and with insulin with or without metformin. 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 DPP-4-inhibitor medicines.
The Committee therefore concluded that the benefits
of Trajenta outweigh its risks and recommended that it be granted marketing
authorisation.
Other information about Trajenta
The European Commission granted a marketing
authorisation valid throughout the European Union for Trajenta on 24 August
2011.
For more information about treatment with Trajenta,
read the package leaflet (also part of the EPAR) or contact your doctor or
pharmacist.
Source: European Medicines Agency
