Onglyza 2.5 mg film-coated tablets

ATC Code
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Bristol-Myers Squibb/AstraZeneca EEIG

Substance Narcotic Psychotropic
Saxagliptin No No
Pharmacological group Blood glucose lowering drugs, excl. insulins


All to know


Bristol-Myers Squibb/AstraZeneca EEIG

What is it?

Onglyza is a medicine that contains the active substance saxagliptin. It is available as round tablets (yellow: 2.5 mg and pink: 5 mg).

What is it used for?

Onglyza is used in adults who have type 2 diabetes to control their blood glucose (sugar) level. Onglyza is used together with other antidiabetes medicines in the following ways:

with metformin in patients whose glucose levels are not satisfactorily controlled on metformin with diet and exercise

with a sulphonylurea in patients whose glucose levels are not satisfactorily controlled on sulphonylurea with diet and exercise and in whom treatment with metformin is not considered appropriate

with a thiazolidinedione in patients whose glucose levels are not satisfactorily controlled on thiazolidinedione with diet and exercise.

The medicine can only be obtained with a prescription.


How is it used?

The recommended dose of Onglyza is 5 mg taken once a day, at any time of the day. The dose of Onglyza should be reduced to 2.5 mg once a day in patients with moderate or severe renal 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 in the blood or when the body is unable to use insulin effectively. The active substance in Onglyza, saxagliptin, 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 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. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has it been studied?

Onglyza was investigated in six main studies involving 4,148 adults with type 2 diabetes.

Three of the studies compared Onglyza with placebo, when they were added to metformin, a thiazolidinedione or a sulphonylurea in a total of 2,076 patients in whom previous treatment had failed.

In one ?initial combination? study, the combination of Onglyza and metformin was compared with Onglyza or metformin alone in patients who had not previously received substantial treatment with antidiabetes medicines. The company also presented two studies, comparing Onglyza on its own with placebo but did not apply for Onglyza to be used alone.

The main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. HbA1c levels were measured after 24 weeks.

What benefits has it shown during the studies?

Onglyza was more effective than placebo at controlling blood glucose, when used as an ?add-on? in patients in whom previous treatment had failed. In patients who took Onglyza in addition to metformin, HbA1c levels had fallen by around 0.7% after 24 weeks (from around 8.1% to around 7.4%) compared with an increase of around 0.1% in patients taking placebo. For patients who took Onglyza with a sulphonylurea and a thiazolidinedione, HbA1c levels fell by around 0.6% and 0.9%, respectively, compared with an increase of around 0.1% and a decrease of around 0.3%, respectively, in patients who took placebo.

The results of the initial combination study were not considered to be clinically relevant and the company withdrew its application for the use of Onglyza as an initial combination medicine in previously untreated patients.

What is the risk associated?

The most common side effects with Onglyza (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), urinary tract infection (infection of the structures that carry urine), gastroenteritis (inflammation of the stomach and gut), sinusitis (inflammation of the sinuses), headache, vomiting and mild to moderate peripheral oedema (swelling, especially of the ankles and feet) in patients taking Onglyza with a thiazolidinedione. For the full list of all side effects reported with Onglyza, see the package leaflet.

Onglyza should not be used in people who may be hypersensitive (allergic) to saxagliptin or any of the other ingredients.

Why has it been approved?

The CHMP decided that Onglyza?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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