Ryzodeg is available as a solution for injection in a cartridge (100 units/ml) and in a prefilled pen (100 units/ml).
Ryzodeg is used to treat diabetes in adults, adolescents and children from 2 years of age. The medicine can only be obtained with a prescription.
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 for the insulin normally 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. 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 as soon as it is injected and has a short duration of action.
The replacement insulin acts in the same way as natural insulin, and helps glucose from the blood to enter cells. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced. Injecting Ryzodeg at a main meal provides long-acting insulin to control blood sugar until the next dose as well as short-acting insulin to help deal with the extra sugar from the meal.
The studies in adults 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 (in percentage points) was 0.7 in patients with type 1 diabetes and between 1 and 1.7 across the trials in patients with type 2 diabetes. In the study in children, the combined used of Ryzodeg and insulin aspart was at least as effective as insulin detemir and insulin aspart, with average HbA1c reductions of 0.27 and 0.23 percentage points respectively.
The CHMP concluded that Ryzodeg is effective in controlling blood glucose levels in adults, adolescents and children aged over 2 years with diabetes. Because the dose requirements in young children may not be stable and because they cannot express symptoms of hypoglycaemia, Ryzodeg is not suitable for children aged under 2 years. The Committee concluded that Ryzodeg is generally safe and its side effects are comparable to those of other insulin analogues. It also noted that in the studies with adults Ryzodeg reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2diabetes. The CHMP decided that Ryzodeg’s benefits are greater than its risks and recommended that it be given marketing authorisation.