Insulatard

insulin human (rDNA)

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Insulatard?

Insulatard is a range of insulin suspensions for injection. Insulatard is supplied in vials, cartridges (Penfill), or prefilled pens (InnoLet, NovoLet and FlexPen). Insulatard contains the active substance insulin human (rDNA).

What is Insulatard used for?

Insulatard is used in patients with diabetes.

The medicine can only be obtained with a prescription.

How is Insulatard used?

Insulatard is given subcutaneously (under the skin) by injection, usually in the thigh. If convenient, it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder). The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose. Insulatard is a long-acting insulin. It can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’s recommendation.

How does Insulatard work?

Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose. Insulatard is a replacement insulin which identical to the insulin made by the pancreas. The active substance in Insulatard, insulin human (rDNA), is produced by a method known as ‘recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin. Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane’ form which is absorbed much more slowly during the day. This gives Insulatard a longer duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the blood glucose, the symptoms and complications of diabetes are reduced.

How has Insulatard been studied?

Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type-1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type-2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients). In most patients, Insulatard was compared with other types of human insulin or insulin analogues. The studies measured the levels of fasting blood glucose or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a prefilled pen (InnoLet, NovoPen or FlexPen).

What benefit has Insulatard shown during the studies?

Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins. Insulatard was effective for both type-1 and type-2 diabetes, and when using a standard injection or one of the pens.

What is the risk associated with Insulatard?

As with all insulins, Insulatard may cause hypoglycaemia (low blood glucose). For the full list of all side effects reported with Insulatard, see the package leaflet.

Insulatard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients. Insulatard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose. The full list is available in the package leaflet.

Why has Insulatard been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Insulatard’s benefits are greater than its risks for the treatment of diabetes. The Committee recommended that Insulatard be given marketing authorisation.

Other information about Insulatard

The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard to Novo Nordisk A/S on 7 October 2002. The marketing authorisation was renewed on 7 October 2007.

This EPAR was last updated on 14/09/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

27/06/2012  Insulatard -EMEA/H/C/000441 -II/0051/G

Contents

• 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents