What is NovoMix?
NovoMix includes a series of injectable suspensions, available in cartridges or in pre-filled pens. NovoMix contains the active substance insulin aspart 100 units (U) per milliliter in the following ratio:
• NovoMix 30: 30% soluble insulin aspart (fast action) and 70% protamine-crystallized insulin aspart (prolonged action);
• NovoMix 50: 50% of soluble insulin aspart (fast action) and 50% of protamine-crystallized insulin aspart (prolonged action);
• NovoMix 70: 70% soluble insulin aspart (fast action) and 30% protamine-crystallized insulin aspart (prolonged action).
What is NovoMix used for?
NovoMix is indicated for the treatment of patients with diabetes.
The medicine can only be obtained with a prescription.
How is NovoMix used?
NovoMix is administered subcutaneously (under the skin) by injection into the abdominal wall or thigh. Alternatively, the deltoid region (shoulder) or glutea (buttocks) can be used. To find the minimum effective dosage it is necessary to regularly monitor the serum level of glucose (sugar). NovoMix should be given immediately before a meal, but if necessary it can also be given immediately after a meal. Generally the dose is between 0.5 and 1.0 U per kilogram of body weight per day.
In patients with type 2 diabetes (also known as non-insulin-dependent diabetes), NovoMix can be given alone or in combination with metformin. NovoMix 30 can also be used with other antidiabetic medicines that can be taken by mouth in combination with insulin, but with pioglitazone it should be administered only after assessing the patient's risk of reporting side effects related to fluid retention. For more information, see the Summary of Product Characteristics, which is also included with the EPAR.
How does NovoMix work?
Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood glucose levels. NovoMix is an insulin analogue very similar to the insulin produced by the pancreas. The active ingredient of NovoMix, insulin aspart, is obtained by a method known as "recombinant DNA technology": that is, it is obtained from a yeast in which a gene (DNA) has been introduced that makes it capable of producing insulin aspart . Insulin aspart differs very little from human insulin, but thanks to this difference it can be absorbed more quickly by the body and therefore can act faster than human insulin. NovoMix contains two forms of insulin aspart: the soluble form, which acts quickly (in the 10 minutes after the injection), and the crystallized form, which is absorbed much more slowly throughout the day. This gives NovoMix a longer action. Replacement insulin has the same mechanisms of action as natural insulin and promotes the penetration of glucose into blood cells. By controlling the blood sugar level, it reduces the symptoms and complications of diabetes.
How has NovoMix been studied?
NovoMix 30 has been studied in patients with type 1 or 2 diabetes (294 patients) and was compared over 12 weeks with human insulin. NovoMix 50 and NovoMix 70 given by injection three times a day were compared in 664 patients (with type 1 or 2 diabetes), with human insulin 30 injected twice a day. In addition, 4 studies were conducted, involving a total of 905 patients, on the effects of NovoMix 30 as an adjunctive therapy compared to other oral antidiabetic drugs (metformin, sulfonylurea and pioglitazone). In all the studies the main measure of effectiveness was the change in the blood concentration of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the efficacy of blood glucose control, at the beginning and at the end of the study.
What benefit has NovoMix shown during the studies?
At the end of the study NovoMix 30 gave mostly identical results compared to human insulin. NovoMix 50 and NovoMix 70 showed greater overall control of blood glucose than human insulin 30. NovoMix 30 used as an adjunctive therapy to other antidiabetic drugs allowed greater control of blood glucose to be obtained compared to other drugs used as monotherapy (from only).
What is the risk associated with NovoMix?
Like other types of insulin, NovoMix can cause hypoglycaemia (decreased blood glucose concentration). For the full list of all side effects reported with NovoMix, see the Package Leaflet.
NovoMix should not be used in people who may be hypersensitive (allergic) to insulin aspart or any of the ingredients, or to patients with hypoglycaemia. It may also be necessary to adjust the dosage of NovoMix in case of concomitant administration with other drugs which may affect blood glucose. For the complete list, see the package leaflet.
Why has NovoMix been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoMix's benefits are greater than its risks for the treatment of diabetes mellitus. The Committee therefore recommended that NovoMix be granted marketing authorization.
More information on NovoMix:
On 1 August 2000, the European Commission issued a marketing authorization valid for NovoMix, valid throughout the European Union, to Novo Nordisk A / S. The marketing authorization was renewed on 1 August 2005.
The full EPAR for NovoMix can be found here.
Last update of this summary: 08-2007
