Author: Takeda Global Research and Development Centre (Europe) Ltd.


Long information

What is it?

Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride. It is available as white, round tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Tandemact is used to treat adult patients who have type 2 diabetes (also known as non-insulin-dependent diabetes). It is used in patients for whom metformin (a type of anti-diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances, pioglitazone and glimepiride.
The medicine can only be obtained with a prescription.

How is it used?

The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day. The tablet should be swallowed whole with a little water. Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i.e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact. Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.
Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems.

How does it 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. Tandemact contains two active substances, each of which has a different mode of action. Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin. As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.

How has it been studied?

Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature. Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. The company used three studies to support the use of Tandemact in the same indication. The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea. The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
These studies used pioglitazone and sulphonylureas given as separate tablets. The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.

What benefits has it shown during the studies?

In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose. The patients? HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%. At least 64% of the patients treated were classified as ?responders?, since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.

What is the risk associated?

The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are weight gain, dizziness, flatulence (gas) and oedema (swelling). For the full list of all side effects reported with Tandemact, see the Package Leaflet.
Tandemact should not be used in people who may be hypersensitive (allergic) to pioglitazone, glimepiride or any of the other ingredients, or to other sulphonylureas or to sulphonamides. It should not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys. It should not be used in patients with type 1 diabetes (insulin-dependent diabetes), patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breast-feeding.
Doses of Tandemact may need to be adjusted when given with some other medicines. The full list of these medicines is available in the Summary of Product Characteristics, which is also part of the EPAR.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed. The Committee decided that Tandemact?s benefits are greater than its risks for the treatment of type 2 diabetes in patients who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride. The Committee recommended that Tandemact be given marketing authorisation.

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