This is a summary of the European public assessment report (EPAR) for Ryzodeg. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ryzodeg.
- What is Ryzodeg?
Ryzodeg is a medicine that contains the active substances insulin degludec and insulin aspart. It is available as a solution for injection in a cartridge (100 units/ml) and in a prefilled pen (100 units/ml).
- What is Ryzodeg used for?
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?
Ryzodeg is injected either once or twice per day, at mealtimes. It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh. The place within the chosen area should be altered with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of Ryzodeg absorbed.
The correct dose is determined individually for each patient. In type-1 diabetes, Ryzodeg is used in combination with rapid-acting insulin, which is injected at other mealtimes.
- How does Ryzodeg work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively. Ryzodeg is a replacement insulin that is very similar to the insulin made by the body.
The active substances in Ryzodeg, insulin degludec and insulin aspart, are produced by a method known as ‘recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes the yeast able to produce them.
Insulin degludec and insulin aspart are slightly different from human insulin. The differences mean that insulin degludec is absorbed more slowly by the body, and takes longer to reach its target in the body. This means it has a long duration of action. Meanwhile, insulin aspart is absorbed faster by the body than human insulin, and therefore it starts to work soon after it is injected and has a short duration of action.
The replacement insulin acts in the same way as naturally produced insulin, and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
- How has Ryzodeg been studied?
The effects of Ryzodeg were first tested in experimental models before being studied in humans.
Ryzodeg has been 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. The studies compared Ryzodeg given at mealtimes with insulin glargine or insulin detemir (long-acting insulins), or with biphasic insulin (an insulin formulation consisting of a mixture of intermediate- and rapid-acting insulin). In the studies in type-1 diabetes, patients also received injections of rapid-acting insulin at other mealtimes. In the studies in type-2 diabetes, Ryzodeg was either given alone or in combination with other antidiabetes medicines.
All of the studies measured the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose. HbA1c gives an indication of how well the blood glucose is controlled. All the studies lasted six months, but one was extended to one year.
- What benefit has Ryzodeg shown during the studies?
The studies showed that Ryzodeg was 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. The reduction in HbA1c levels was 0.7% in patients with type-1 diabetes and ranged from 1% to 1.7% across the trials in patients with type-2 diabetes.
- What is the risk associated with Ryzodeg?
The most frequently reported side effect during treatment with 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 been approved?
The CHMP concluded 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 Ryzodeg is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported.
It also noted that Ryzodeg reduces the risk of hypoglycaemia during the night in patients with type-1 and type-2 diabetes. The CHMP decided that Ryzodeg’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- Other information about Ryzodeg
The European Commission granted a marketing authorisation valid throughout the European Union for Ryzodeg on 21 January 2013.
For more information about treatment with Ryzodeg, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 20/02/2013 .
21/01/2013 Ryzodeg -EMEA/H/C/002499 --
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Treatment of diabetes mellitus in adults
Changes since initial authorisation of medicine
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Initial marketing-authorisation documents
This medicine is approved for use in the European Union