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Komboglyze Approved to Treat Diabetes Mellitus, Type 2

Komboglyze is a medicine that contains the active substances saxagliptin and metformin. It is available as tablets (2.5 mg / 850 mg or 2.5 mg / 1,000 mg).

Komboglyze is used in addition to diet and exercise to improve the control of blood glucose (sugar) levels in patients with type 2 diabetes. It is used in patients whose blood glucose levels are not adequately controlled by metformin alone (another antidiabetes medicine). It can also be used in patients already being treated with saxagliptin and metformin as separate tablets.

The medicine can only be obtained with a prescription.
Komboglyze is taken as one tablet twice a day at mealtimes. Patients not adequately controlled on metformin alone who start taking Komboglyze should continue to receive the same dose of metformin they were previously taking. Patients already adequately controlled with saxagliptin and metformin from separate tablets who switch to the Komboglyze should use the tablet containing the same component doses.
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 Komboglyze, saxagliptin and metformin, each have a different mode of action to help reduce blood glucose levels and control type 2 diabetes.

Saxagliptin is a dipeptidyl peptidase 4 (DPP4) 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 increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Saxagliptin does not work when the blood glucose is low. Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Saxagliptin has been authorised in the EU as Onglyza since 2009.

The active substance metformin works mainly by blocking glucose production and reducing its absorption in the gut. Metformin has been available in the EU since the 1950s.

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

The effects of Komboglyze were first tested in experimental models before being studied in humans.

The company presented the results of one new main study in patients with type 2 diabetes and five other studies which had already been assessed for the authorisation of Onglyza.

The new study examined the effects of saxagliptin 2.5 mg taken twice daily compared with placebo when added to metformin in 160 patients whose blood glucose levels were not adequately controlled by metformin alone. The effects were measured after 12 weeks of treatment. The other five studies looked at the effects of saxagliptin (at various strengths) alone or in combination with metformin, compared either with placebo or a comparator medicine (a sulphonylurea or sitagliptin) in over 4,000 patients with type 2 diabetes. The main measure of effectiveness in all the studies was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

The company also presented the results of a study in 32 healthy people looking at the levels of saxagliptin in the blood when saxagliptin is taken at 2.5 mg twice daily compared with when it is taken at 5 mg once daily.
In the main study, patients taking saxagliptin 2.5 mg twice daily together with metformin had a reduction of 0.6% in their levels of HbA1c, compared with a reduction of 0.2% in patients taking placebo together with metformin. The other five studies also showed that adding saxagliptin to metformin was effective at reducing levels of HbA1c.

The study in healthy people showed that when saxagliptin is taken at 2.5 mg twice daily it produces the same levels of active substance in the blood over a 24 hour period as when it is taken at 5 mg once daily.
The most common side effects seen with saxagliptin (seen in between 1 and 10 patients in 100) are upper respiratory infection (cold), urinary tract infection (infection of the structures that carry urine such as the bladder), gastroenteritis (diarrhoea and vomiting), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, vomiting, nausea (feeling sick) and rash. The most common side effects seen with metformin (seen in more than 1 patient in 10) are gastrointestinal symptoms (symptoms affecting the stomach and gut).

Komboglyze must not be used in patients who are hypersensitive (allergic) to saxagliptin and metformin or any of the other ingredients, or who have ever had a serious allergic reaction to any DPP4 inhibitor. It must not be used in patients suffering diabetic ketoacidosis or diabetic pre-coma (a dangerous condition that can occur in diabetes), patients with moderate to severe kidney problems or suffering from acute (sudden) conditions which can affect kidney function, patients suffering from acute or chronic diseases which can cause tissue hypoxia (where the tissue is deprived of adequate oxygen supply) such as heart failure or difficulty breathing, patients with liver problems, alcohol poisoning or alcoholism. It must not be used in women who are breastfeeding..
The CHMP concluded that Komboglyze helps to reduce blood glucose levels in patients whose blood glucose levels are not adequately controlled by metformin alone, while the combination of saxagliptin and metformin in one tablet may help patients who already take both to follow their treatment correctly. The CHMP also noted that the combination does not cause any unexpected side effects. The Committee therefore concluded that the benefits of Komboglyze outweigh its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Komboglyze on 24 November 2011.

Prepared by: Houssam Nahhas

Source :

European Medicines Agency

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