diabetes drugs

Actraphane - insulin

Characteristics of the medicinal product

Actraphane is a series of injectable insulin suspensions. Actraphane is available in vials, cartridges (Penfill) or pre-filled pens (NovoLet, FlexPen or InnoLet). The active substance in Actraphane is human insulin (DNAr). Actraphane is a mixture of fast-acting (soluble) insulin and long-acting insulin (isophane).

Actraphane 10: 10% soluble insulin and 90% isophane insulin

Actraphane 20: 20% soluble insulin and 80% isophane insulin

Actraphane 30: 30% soluble insulin and 70% isophane insulin

Actraphane 40: 40% soluble insulin and 60% isophane insulin

Actraphane 50: 50% soluble insulin and 50% isophane insulin

Therapeutic indications

Actraphane is used in patients with diabetes.

The medicine can only be obtained with a prescription.

Method of use

Actraphane is given by subcutaneous injection (under the skin), normally in the abdominal region (belly), but it can also be administered, if more convenient, in the gluteal region (buttocks) or in the deltoid region (shoulder). It is advisable to regularly check the patient's blood sugar level to find the lowest effective dose. The usual dose ranges from 0.3 to 1.0 IU / kg / day. Actraphane is normally given once or twice a day if you want a quick initial effect along with a longer lasting effect.

Mechanisms of action

Diabetes is a disease in which the body does not produce enough insulin to control blood sugar. Actraphane is an insulin substitute identical to the insulin made by the pancreas. The active ingredient in Actraphane, human insulin (DNAr), is produced by a method known as "recombinant technology": that is, insulin is produced by a yeast in which it is

A gene (DNA) has been introduced that makes it able to produce it. Actraphane contains insulin in two forms: the soluble form, which acts quickly (within 30 minutes of injection) and the "isophane" form, which is absorbed much more slowly during the day, which gives Actraphane a longer lasting effect. The insulin substitute acts like naturally produced insulin and promotes the penetration of glucose into the cells from the blood. By controlling blood sugar, the symptoms and complications of diabetes are reduced.

Studies carried out

Actraphane has been studied in a total of 294 patients with type 1 diabetes, in which the pancreas is unable to produce insulin, and type 2, in which the body is unable to use insulin in a manner effective. About one-third of patients had type 1 diabetes (others from type 2 diabetes). In the study, Actraphane 30 was compared to a similar mixture, but prepared using an insulin analog (insulin aspart). The level of a substance, glycosylated hemoglobin (HbA1c), which gives an indication of the efficacy of blood glucose control, was measured after 12 weeks in the study.

Benefits found following the studies

Actraphane caused a decrease in the level of HbA1c, indicating that blood sugar levels were controlled to a level similar to that found with other human insulins. Actraphane has been shown to be effective in both type 1 and type 2 diabetes.

Associated risks

Actraphane may cause hypoglycemia (low blood glucose). For the full list of all side effects reported with Actraphane, see the Package Leaflet.

Actraphane should not be used in people who may be hypersensitive (allergic) to human insulin (DNAr) or other ingredients in the medicine. The doses of Actraphane should be adjusted if the medicine is given with other medicines that may have an effect on blood sugar (the full list can be found in the package insert).

Grounds for approval

The Committee for Medicinal Products for Human Use (CHMP) decided that Actraphane's benefits are greater than its risks for the treatment of diabetes. The CHMP therefore recommended the granting of a marketing authorization for Actraphane.

Further information

On 7 October 2002, the European Commission issued a marketing authorization for Actraphane, valid throughout the European Union, to Novo Nordisk A / S.

The full EPAR for Actraphane can be found here.

Last update of this summary: January 2006