What is Komboglyze - Saxagliptin / metformin?
Komboglyze is a medicine that contains active substances such as saxagliptin and metformin and is available as tablets (2.5 mg / 850 mg or 2.5 mg / 1 000 mg).
What is Komboglyze - Saxagliptin / metformin used for?
Komboglyze is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes whose blood glucose level is not adequately controlled with metformin alone (another antidiabetic) or in those patients already being treated. with the combination of saxagliptin and metformin in separate tablets.
The medicine can only be obtained with a prescription.
How is Komboglyze used - Saxagliptin / metformin?
Komboglyze is taken in the amount of one tablet twice a day with meals. Patients inadequately controlled on metformin monotherapy (alone) starting treatment with Komboglyze should still receive the usual dose of metformin. Patients adequately controlled on the combination saxagliptin and metformin separate tablets who switch to a regimen with Komboglyze should take the tablet containing the same doses as the components.
How does Komboglyze - Saxagliptin / metformin 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 ingredients in Komboglyze, saxagliptin and metformin, each work differently to help lower blood sugar levels and control type 2 diabetes.
Saxagliptin is a dipeptidyl peptidase 4 (DPP4) inhibitor. It works by inhibiting the breakdown of "incretin" hormones in the body. These hormones are released after food and 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.Saxagliptin was authorized for use in the European Union in 2009 with the drug Onglyza.
The active substance metformin works mainly by blocking the production of glucose and reducing its absorption in the intestine. Metformin has been available in the EU since the 1950s.
As a result of the action of the two active ingredients, blood glucose levels are reduced allowing the control of type 2 diabetes.
How has Rasitrio been studied?
Before being studied in humans, the effects of Komboglyze were first tested in experimental models.
The company presented the results of a new main study in patients with type 2 diabetes, along with the results of five other studies that had already been evaluated for authorization of Onglyza.
The new study looked at the effects of saxagliptin 2.5 mg taken twice daily, comparing them to those of placebo added to metformin in 160 patients whose blood glucose values were not adequately controlled on metformin alone. The effects were analyzed after 12 weeks of treatment. The other five studies looked at the effects of saxagliptin (in different strengths) used alone or in combination with metformin in over 4,000 patients with type 2 diabetes, compared to placebo or a comparator (sulphonylurea or sitagliptin). In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated hemoglobin (HbA1c), which gives an "indication of how well the blood glucose is controlled.
The company also presented the results of a study conducted in 32 healthy subjects in which the levels of saxagliptin in the blood were observed when taking a dose of 2.5 mg twice daily compared to a dose of 5 mg. once a day.
What benefit has Rasitrio shown during the studies?
In the pivotal study, patients receiving saxagliptin 2.5 mg taken twice daily in combination with metformin had a 0.6% reduction in HbA1c levels, compared with a 0.2% reduction in patients treated with placebo in combination with metformin. The other five studies also found that adding saxagliptin to metformin was effective in reducing HbA1c levels.
The study in healthy subjects showed that, over a 24-hour period, taking 2.5 mg of saxagliptin twice a day produces the same levels of the active substance in the blood as seen with taking 5 mg once. per day.
What is the risk associated with Rasitrio?
The most common side effects seen with saxagliptin (seen in 1 to 10 patients in 100) are upper respiratory infections (colds), urinary tract infections (urinary tract infections such as bladder), gastroenteritis (diarrhea and vomiting), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, vomiting, nausea (feeling sick) and skin rashes. The most common side effects seen with metformin (seen in more than 1 in 10 patients) are gastrointestinal symptoms (affecting the stomach and intestines). For the full list of side effects reported with saxagliptin and metformin, see the package leaflet.
Komboglyze must not be used in patients who are hypersensitive (allergic) to saxagliptin and metformin or any of the other substances, or who have experienced a severe allergic reaction to one of the DPP4 inhibitors. It is contraindicated in patients with diabetic ketoacidosis or diabetic pre-coma (a dangerous condition that can occur due to diabetes), moderate or severe kidney failure or acute (sudden) states that can impair kidney function, acute or chronic disease that can cause tissue hypoxia (which occurs when the tissue is lacking an adequate supply of oxygen) such as heart or respiratory failure, liver failure, acute alcohol intoxication or alcoholism. It should not be administered during lactation. For the full list of restrictions, see the package leaflet.
Why has Komboglyze - Saxagliptin / metformin been approved?
The CHMP concluded that Komboglyze helps to lower blood glucose in patients whose blood glucose levels are not adequately controlled with metformin alone, while the combination of saxagliptin and metformin given in a single tablet may help patients who already take both substances to follow the treatment correctly. The CHMP also noted that this combination does not cause any unexpected side effects and therefore decided that the benefits of Komboglyze outweigh its risks and recommended that it be licensed to ' placing on the market for the medicinal product.
More information about Komboglyze - Saxagliptin / metformin
On 24 November 2011, the European Commission issued a "Marketing Authorization" for Komboglyze, valid throughout the European Union.
For more information about Komboglyze therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
The information on Komboglyze - Saxagliptin / metformin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
