Trajenta | European Medicines Agency (EMA) (2024)

Application under evaluation
CHMP opinion
European Commission decision

Overview

This is a summary of the European public assessment report (EPAR) for Trajenta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Trajenta.

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 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.

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).

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.

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.

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.

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.

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.

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.

Trajenta : EPAR - Summary for the public

English (EN) (76.28 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

Other languages (21)

български (BG) (103.51 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

español (ES) (75.69 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

čeština (CS) (101.42 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

dansk (DA) (74.05 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

Deutsch (DE) (75.74 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

eesti keel (ET) (73.86 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

ελληνικά (EL) (103.19 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

français (FR) (75.69 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

italiano (IT) (74.31 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

latviešu valoda (LV) (98.04 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

lietuvių kalba (LT) (96.95 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

magyar (HU) (94.28 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

Malti (MT) (101.56 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

Nederlands (NL) (74.77 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

polski (PL) (100.03 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

português (PT) (96.87 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

română (RO) (96.59 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

slovenčina (SK) (100.08 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

View

slovenščina (SL) (90.89 KB - PDF)

First published: 06/10/2011Last updated: 15/04/2013

Product information

Trajenta : EPAR - Product Information

English (EN) (214.06 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

Other languages (24)

български (BG) (255.52 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

español (ES) (223.02 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

čeština (CS) (233.42 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

dansk (DA) (260.11 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

Deutsch (DE) (240.48 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

eesti keel (ET) (219.26 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

ελληνικά (EL) (235.68 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

français (FR) (229.07 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

hrvatski (HR) (226.81 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

íslenska (IS) (227.5 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

italiano (IT) (217.81 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

latviešu valoda (LV) (226.55 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

lietuvių kalba (LT) (221.66 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

magyar (HU) (251.61 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

Malti (MT) (270.34 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

Nederlands (NL) (230.85 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

norsk (NO) (217.52 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

polski (PL) (238.09 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

português (PT) (235.79 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

română (RO) (247.74 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

slovenčina (SK) (231.11 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

slovenščina (SL) (208.06 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

Suomi (FI) (218.95 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

svenska (SV) (216.82 KB - PDF)

First published: 06/10/2011Last updated: 05/12/2023

View

Latest procedure affecting product information: IB/0052

04/12/2023

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

summary of product characteristics(annex I);
manufacturing authorisationholder responsible for batch release (annex IIA);
conditions of themarketing authorisation(annex IIB);
labelling(annex IIIA);
package leaflet(annex IIIB).

Trajenta : EPAR - All Authorised presentations

English (EN) (64.96 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

Other languages (24)

български (BG) (54.68 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

español (ES) (50.13 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

čeština (CS) (70.56 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

dansk (DA) (50.26 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

Deutsch (DE) (91.31 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

eesti keel (ET) (48.01 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

ελληνικά (EL) (63.2 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

français (FR) (51.27 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

hrvatski (HR) (57.05 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

íslenska (IS) (49.47 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

italiano (IT) (49.51 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

latviešu valoda (LV) (81.19 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

lietuvių kalba (LT) (82.4 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

magyar (HU) (79.92 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

Malti (MT) (79.49 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

Nederlands (NL) (63.34 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

norsk (NO) (49.32 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

polski (PL) (72.56 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

português (PT) (50.42 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

română (RO) (54.08 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

slovenčina (SK) (77.44 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

slovenščina (SL) (26.78 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

Suomi (FI) (64.64 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

svenska (SV) (50.36 KB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

Product details

Name of medicine: Trajenta
Active substance: linagliptin
International non-proprietary name (INN) or common name: linagliptin
Therapeutic area (MeSH): Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code: A10BH05

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.

Authorisation details

EMA product number: EMEA/H/C/002110
Marketing authorisation holder: Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
Marketing authorisation issued: 23/08/2011
Revision: 21

Assessment history

Trajenta : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (193.72 KB - PDF)

First published: 03/05/2012Last updated: 05/12/2023

View

Trajenta - EPAR - Paediatric investigation plan compliance statement

Reference Number: EMA/CHMP/141255/2023

English (EN) (110.63 KB - PDF)

First published: 10/05/2023

View

Trajenta-H-C-002110-II-0049 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/212741/2023

English (EN) (1.62 MB - PDF)

First published: 10/05/2023

View

Trajenta-H-C-2110-WS0915 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/ /215439/2017

English (EN) (1.5 MB - PDF)

First published: 12/07/2018Last updated: 12/07/2018

View

CHMP Post-authorisation summary of positive opinion for Trajenta (CHMP)

English (EN) (71.47 KB - PDF)

First published: 16/12/2016Last updated: 16/12/2016

View

Trajenta : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/83549/2016

English (EN) (68.33 KB - PDF)

First published: 14/03/2016Last updated: 14/03/2016

View

Trajenta-H-C-2110-II-0004-G : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/508574/2012

English (EN) (1.35 MB - PDF)

First published: 05/12/2012Last updated: 05/12/2012

View

CHMP post-authorisation summary of positive opinion for Trajenta

AdoptedReference Number: EMA/591330/2012

English (EN) (58.85 KB - PDF)

First published: 21/09/2012Last updated: 21/09/2012

View

Trajenta : EPAR - Public assessment report

AdoptedReference Number: EMA/604444/2011

English (EN) (1.23 MB - PDF)

First published: 06/10/2011Last updated: 06/10/2011

View

CHMP summary of positive opinion for Trajenta

AdoptedReference Number: EMA/CHMP/450821/2011

English (EN) (53.4 KB - PDF)

First published: 24/06/2011Last updated: 24/06/2011

View

News on Trajenta

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013

26/07/2013

Investigation into GLP-1-based diabetes therapies concluded

26/07/2013

European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes

26/03/2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012

21/09/2012

Clinical data (variation WS0915)

More information on Trajenta

EMEA-000498-PIP01-08-M10 - paediatric investigation plan

Topics

Medicines

This page was last updated on 05/12/2023