Incresync

alogliptin / pioglitazone

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This is a summary of the European public assessment report (EPAR) for Incresync. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Incresync.

For practical information about using Incresync, patients should read the package leaflet or contact their doctor or pharmacist.

What is Incresync and what is it used for?

Incresync is a diabetes medicine containing the active substances alogliptin and pioglitazone. It is used as an addition to diet and exercise in adults with type-2 diabetes to improve the control of blood glucose (sugar) levels:

  • in patients who are not satisfactorily controlled with pioglitazone alone, and who cannot be treated with metformin (another diabetes medicine);
  • together with metformin, in patients who are not satisfactorily controlled with a combination of pioglitazone and metformin.

Incresync can also be used as a replacement tablet (supplying both alogliptin and pioglitazone) in patients who are already being treated with alogliptin and pioglitazone given separately.

How is Incresync used?

Incresync is available as tablets (12.5 or 25 mg alogliptin and 30 mg pioglitazone; 12.5 or 25 mg alogliptin and 45 mg pioglitazone) and can only be obtained with a prescription. It is taken by mouth once daily. The choice of tablet strength to start with depends on the patient’s current treatment. If patients were previously taking pioglitazone alone, the strength of Incresync that provides the same dose of pioglitazone should be used. If patients are also taking metformin, lower doses of metformin or pioglitazone may need to be given to reduce the risk of hypoglycaemia (low blood sugar levels). If patients were previously taking pioglitazone and alogliptin separately, Incresync should be used in a strength that continues to provide the same doses. The dose should be lowered in patients with moderately reduced kidney function. 

For further information, see the summary of product characteristics (also part of the EPAR).

How does Incresync work?

Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substances in Incresync, alogliptin and pioglitazone, work in different ways to help correct this.

Alogliptin 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 blocking the breakdown of Incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high. Alogliptin does not work when the blood glucose is low. Alogliptin 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. Alogliptin is licensed in the EU as Vipidia.

Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. Pioglitazone is authorised in the EU as Actos and associated names.

As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type-2 diabetes.

What benefits of Incresync have been shown in studies?

Incresync has been studied in two main studies involving 1,296 patients with type-2 diabetes that was not well controlled by previous treatment. One of the studies compared the effects of alogliptin with placebo (a dummy treatment) when used as an add-on to existing treatment with pioglitazone (the same combination as in Incresync), with or without metformin or another diabetes medicine. In the other study, the effects of adding alogliptin to existing treatment with pioglitazone and metformin was compared with increasing the doses of pioglitazone. In both studies, the main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached. HbA1c levels give an indication of how well the blood glucose is controlled. HbA1c levels were measured after 26 weeks in the first study and 52 weeks in the second study.

Both studies showed that the combination of active substances in Incresync could produce a small but clinically relevant improvement in HbA1c. When added to pioglitazone, the improvement was a fall of 0.47% at a dose of alogliptin of 12.5 mg, and 0.61% for alogliptin 25 mg. Incresync was at least as effective as pioglitazone and metformin in reducing HbA1c.

What are the risks associated with Incresync?

The most common side effects with Incresync (which may affect up to 1 in 10 people) are upper-respiratory-tract infections (colds), sinusitis, headache, nausea (feeling sick), dyspepsia (heartburn), abdominal pain (tummy ache), pruritus (itching), myalgia (muscle pain), peripheral oedema (swelling in arms and legs) and weight gain. For the full list of all side effects reported with Incresync, see the package leaflet.

Incresync must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any dipeptidyl-peptidase-4 (DPP 4) inhibitor. It must also not be used in patients who have or have ever had heart failure or bladder cancer, those with reduced liver function, diabetic ketoacidosis (a serious condition that can occur in diabetes), or blood in the urine that has not been properly investigated. For the full list of restrictions, see the package leaflet.

Why is Incresync approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Incresync’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that adding alogliptin to existing treatment with pioglitazone with or without metformin had shown to produce modest but clinically relevant improvements in HbA1c. The CHMP therefore considered that the combination of alogliptin and pioglitazone in Incresync is of benefit to patients. Regarding safety, Incresync’s safety profile was consistent with that seen with the individual components.

What measures are being taken to ensure the safe and effective use of Incresync?

A risk-management plan has been developed to ensure that Incresync is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Incresync, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Incresync will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.

Other information about Incresync

The European Commission granted a marketing authorisation valid throughout the European Union for Incresync on 19 September 2013.

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

Name Language First published Last updated
Incresync : EPAR - Summary for the public BG = bălgarski 2013-10-14  
Incresync : EPAR - Summary for the public ES = español 2013-10-14  
Incresync : EPAR - Summary for the public CS = čeština 2013-10-14  
Incresync : EPAR - Summary for the public DA = dansk 2013-10-14  
Incresync : EPAR - Summary for the public DE = Deutsch 2013-10-14  
Incresync : EPAR - Summary for the public ET = eesti keel 2013-10-14  
Incresync : EPAR - Summary for the public EL = elliniká 2013-10-14  
Incresync : EPAR - Summary for the public EN = English 2013-10-14  
Incresync : EPAR - Summary for the public FR = français 2013-10-14  
Incresync : EPAR - Summary for the public IT = italiano 2013-10-14  
Incresync : EPAR - Summary for the public LV = latviešu valoda 2013-10-14  
Incresync : EPAR - Summary for the public LT = lietuvių kalba 2013-10-14  
Incresync : EPAR - Summary for the public HU = magyar 2013-10-14  
Incresync : EPAR - Summary for the public MT = Malti 2013-10-14  
Incresync : EPAR - Summary for the public NL = Nederlands 2013-10-14  
Incresync : EPAR - Summary for the public PL = polski 2013-10-14  
Incresync : EPAR - Summary for the public PT = português 2013-10-14  
Incresync : EPAR - Summary for the public RO = română 2013-10-14  
Incresync : EPAR - Summary for the public SK = slovenčina 2013-10-14  
Incresync : EPAR - Summary for the public SL = slovenščina 2013-10-14  
Incresync : EPAR - Summary for the public FI = suomi 2013-10-14  
Incresync : EPAR - Summary for the public SV = svenska 2013-10-14  
Incresync : EPAR - Summary for the public HR = Hrvatski 2013-10-14  

This EPAR was last updated on 24/02/2017 .

Authorisation details

Product details

Product details for Incresync
NameIncresync
Agency product numberEMEA/H/C/002178
Active substance

alogliptin / pioglitazone

International non-proprietary name (INN) or common name

alogliptin / pioglitazone

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BD09
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Incresync
Marketing-authorisation holder

Takeda Pharma A/S

Revision5
Date of issue of marketing authorisation valid throughout the European Union19/09/2013

Contact address:

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

Product information

11/01/2017  Incresync -EMEA/H/C/002178 -IB/0018/G

Name Language First published Last updated
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24
Incresync : EPAR - Product Information HR = Hrvatski 2013-10-14 2017-02-24

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  
Incresync : EPAR - All Authorised presentations HR = Hrvatski 2013-10-14  

Pharmacotherapeutic group

Drugs used in diabetes; combinations of oral blood-glucose-lowering drugs

Therapeutic indication

Incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: 

  • as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; 
  • in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.

In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination.

After initiation of therapy with Incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Incresync : EPAR - Public assessment report HR = Hrvatski 2013-10-14  
CHMP summary of positive opinion for Incresync HR = Hrvatski 2013-07-26  

Authorised

This medicine is approved for use in the European Union