Ryzodeg - Insulin degludec / insulin aspart
What is Ryzodeg - Insulin degludec / insulin aspart?
Ryzodeg is a medicine that contains the active substances insulin degludec and insulin aspart. It is available as a solution for injection in cartridge (100 units / ml) and in pre-filled pen (100 units / ml).
What is Ryzodeg used for - Insulin degludec / Insulin aspart?
Ryzodeg is used to treat type 1 and type 2 diabetes in adults.
The medicine can only be obtained with a prescription.
How is Ryzodeg used - Insulin degludec / insulin aspart?
Ryzodeg can be given by injection once or twice a day, with meals. The medicine is administered subcutaneously by injection into the abdominal wall, upper arm or thigh. The injection zones must always be alternated within the same area to reduce the risk of lipodystrophy (alterations in the distribution of the body's adipose tissue) at the subcutaneous level, which can interfere with the amount of Ryzodeg absorbed by the body.
The correct dose should be determined according to the individual needs of the patients. In type 1 diabetes, Ryzodeg is used in combination with a "fast-acting insulin, which is given by injection during other meals."
How does Ryzodeg - Insulin degludec / insulin aspart work?
Diabetes mellitus is a disease in which the body does not make enough insulin to control blood glucose levels or is unable to use insulin effectively. Ryzodeg is an insulin analog that is very similar to the insulin produced by the body.
The active substances in Ryzodeg, insulin degludec and insulin aspart, are produced by a method known as the "recombinant DNA technique": they are made by a yeast that has been given a gene (DNA) that makes it able to produce insulin .
Insulin degludec and insulin aspart are slightly different than human insulin. The differences are that insulin degludec is absorbed more slowly by the body and takes longer to reach the target tissue in the body. This means that it has a long duration of action. Insulin aspart, on the other hand, is absorbed more rapidly than human insulin in the body and therefore begins to act shortly after being administered and has a short duration of action.
Replacement insulin has the same mechanisms of action as natural insulin and promotes the penetration of glucose into cells through the blood. By controlling the level of glucose in the blood, it reduces the symptoms and complications of diabetes.
How has Ryzodeg been studied - Insulin degludec / insulin aspart?
Ryzodeg's effects were first tested in experimental models before being studied in humans.
Ryzodeg was studied in one main study involving 548 patients with type 1 diabetes, and in four main studies involving 1 866 patients with type 2 diabetes. In the studies Ryzodeg given with meals was compared with insulin glargine or insulin detemir (long-acting insulins) or with biphasic insulin (an insulin formulation consisting of a combination of intermediate and fast-acting insulin). In the type 1 diabetes studies, patients were also given insulin to rapid-acting at other meals In type 2 diabetes studies Ryzodeg was given alone or in combination with other antidiabetic medicines.
All studies measured the blood concentration of glycosylated hemoglobin (HbA1c), which is the percentage of hemoglobin in the blood that binds to glucose. HbA1c gives an indication of how well the blood glucose is controlled. All studies lasted six months, with the exception of one which lasted for a year.
What benefit has Ryzodeg - Insulin degludec / insulin aspart shown during the studies?
Studies have shown that Ryzodeg is at least as effective as long-acting insulins and biphasic insulin in controlling blood glucose levels in patients with type 1 and type 2 diabetes. 0.7% in patients with type 1 diabetes, while it fluctuated between 1% and 1.7% in patients with type 2 diabetes.
What is the risk associated with Ryzodeg - Insulin degludec / insulin aspart?
The most common side effect of Ryzodeg is hypoglycaemia (low blood glucose levels).
Ryzodeg must not be used in people who are hypersensitive (allergic) to insulin degludec, insulin aspart or any of the other ingredients.
Why has Ryzodeg - Insulin degludec / Insulin aspart been approved?
The CHMP decided that Ryzodeg is effective in controlling blood glucose levels in patients with type 1 and type 2 diabetes. Regarding its safety, the Committee concluded that, in general, Ryzodeg is safe and that its side effects are comparable to other insulin analogues, for which no unexpected side effects are reported. Ryzodeg was also found to reduce the risk of hypoglycaemia at night in patients with type 1 and type 2 diabetes. The CHMP decided that Ryzodeg's benefits outweigh its risks and recommended that it be given a marketing authorization for the medicine.
Other information about Ryzodeg - Insulin degludec / insulin aspart
On 21 January 2013, the European Commission issued a "Marketing Authorization" for Ryzodeg, valid throughout the European Union.
For the complete version of the EPAR for Ryzodeg, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Ryzodeg therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 01-2013.
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