Onglyza - saxagliptin

What is Onglyza?

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

What is Onglyza used for?

Onglyza is used in adults with type 2 diabetes (non-insulin dependent diabetes) to improve the control of blood glucose (sugar) levels. Onglyza is used together with other antidiabetic medicines in the following cases:

• in combination with metformin in patients in whom metformin does not provide sufficient control of glucose levels with diet and exercise;
• in combination with a sulphonylurea in patients in whom the sulphonylurea does not provide sufficient control of glucose levels with diet and exercise and in whom metformin therapy is not considered suitable;
• in combination with a thiazolidinedione in patients whose thiazolidinedione does not provide sufficient control of glucose levels with diet and exercise.

The medicine can only be obtained with a prescription.

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How is Onglyzad used?

The recommended dose of Onglyza is one tablet once a day. Onglyza can be taken at any time of the day, regardless of food intake.

How does Onglyza 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 where 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 inhibiting the breakdown of "incretin" hormones in the body. These hormones, which are released after a meal, stimulate the pancreas to produce insulin. By increasing the level of incretins in the blood, saxagliptin stimulates the pancreas to produce more insulin when the blood sugar level. is high Saxagliptin is ineffective when the blood glucose concentration is low.
Saxagliptin also reduces the amount of glucose produced by the liver by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce the rate of glucose in the blood and help control type 2 diabetes.

How has Onglyza been studied?

The effects of Onglyza were first tested in experimental models before being studied in humans. Onglyza has been studied in six main studies involving 4,148 adults with type 2 diabetes.
Three of these studies compared Onglyza with placebo when metformin, a thiazolidinedione or a sulphonylurea was added in a total of 2,076 patients whose previous treatment did not work.
In an 'initial combination' study, the combination of Onglyza with metformin was compared with Onglyza or metformin alone (alone) in patients who had not previously received substantial therapy with antidiabetic medicines. The company submitted two studies comparing Onglyza alone with placebo but did not apply for Onglyza to be given alone.
The main measure of effectiveness was the change in the level of a substance in the blood called glycosylated hemoglobin (HbA1c), which provides an "indication of how well the blood glucose is controlled. HbA1c levels were measured after 24 weeks.

What benefit has Onglyza shown during the studies?

Onglyza was more effective than placebo at controlling blood glucose as an add-on therapy in patients who did not respond to previous treatment. In patients taking Onglyza in combination with metformin, HbA1c levels fell by approximately 0.7% after 24 weeks (from approximately 8.1% to approximately 7.4%), while there was an increase of approximately 0.1% in patients taking placebo. In patients taking Onglyza in combination with a sulphonylurea and a thiazolidinedione, HbA1c levels fell by approximately 0.6% and 0.9%, respectively, compared with an increase of approximately 0.1% and a decrease of approximately 0.3, respectively. % in patients taking placebo.
The results of the initial combination study were not considered clinically relevant and the manufacturer withdrew the application for the use of Onglyza as the initial combination medicine in previously untreated patients.

What is the risk associated with Onglyza?

The most common side effects seen with Onglyza (seen in 1 to 10 patients in 100) are upper respiratory tract infections (colds), urinary tract infection (infection of the passageways of urine), gastroenteritis (inflammation of the stomach and bowel), sinusitis (inflammation of the sinuses), headache, vomiting and mild to moderate peripheral edema (swelling, particularly of the ankles and feet) in patients taking Onglyza with a thiazolidinedione. For the full list of side effects reported with Onglyza, see the package leaflet. Onglyza must not be used in people who may be hypersensitive (allergic) to saxagliptin or any of the other substances.

Why has Onglyza been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Onglyza's benefits are greater than its risks for treating adults with type 2 diabetes mellitus to achieve a
glycemic control when used in combination with metformin, a sulphonylurea or a thiazolidinedione. The Committee therefore recommended the granting of a marketing authorization for Onglyza.

Other information about Onglyza:

On 1 October 2009, the European Commission granted Bristol-Myers Squibb / AstraZeneca EEIC the "Marketing Authorization" for Onglyza, valid throughout the European Union.
For the full version of the Onglyza EPAR click here.

Last update of this summary: 07-2009.


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