What is Insulatard?
Insulatard includes a series of injectable insulin suspensions. Insulatard is available in vials, cartridges (Penfill) or pre-filled pens (InnoLet, NovoLet and FlexPen). Insulatard contains the active substance insulin human (DNAr).
What is Insulatard used for?
Insulatard is indicated in patients with diabetes.
The medicine can only be obtained with a prescription.
How is Insulatard used?
Insulatard is given as a subcutaneous injection, usually in the thigh. If appropriate, it is possible to inject into the abdominal wall (belly), in the gluteal region (buttocks) or in the deltoid region (shoulder). To find the minimum effective dosage, the glucose (sugar) level must be monitored regularly. Insulatard is a long-acting insulin. It can be given once or twice a day, alone or in combination with fast-acting insulin (at meals), as directed by your doctor.
How does Insulatard work?
Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood glucose levels. Insulatard is an insulin analogue identical to the insulin produced by the pancreas. The active ingredient of Insulatard, human insulin (DNAr), is produced by a method known as "recombinant DNA technique": that is, it is obtained from a yeast with a gene (DNA) that makes it capable of producing insulin. Insulatard contains insulin mixed with another substance, protamine, a form of "isophane insulin" that is absorbed much more slowly during the day. This gives Insulatard a more prolonged action. Replacement insulin has the same mechanisms of action as natural insulin and promotes the penetration of glucose into cells through the blood. By controlling the level of glucose in the blood, it reduces the symptoms and complications of diabetes.
What studies have been carried out on Insulatard?
Insulatard has been studied in four major clinical trials, involving a total of 557 people with type 1 diabetes (ie when the pancreas is unable to produce insulin [two studies involving 81 patients]) or type 2 (when the body is unable to use insulin effectively [two studies involving 476 patients]). In most subjects, Insulatard was compared with other types of human insulin or insulin analogues. These studies measured the fasting blood concentration of glucose or a substance in the blood called glycosylated hemoglobin (HbA1c) which gives an indication of the efficacy of blood glucose control. Other studies have been conducted on 225 patients, in whom the medicine was administered via a syringe or a pre-filled pen (InnoLet, NovoPen or FlexPen).
What benefit has Insulatard shown during the studies?
Insulatard induced a decrease in the level of HbA1c, demonstrating that blood sugar concentrations were maintained at a level similar to that guaranteed by other human insulins. Insulatard has been shown to be effective in both forms of diabetes (type 1 and type 2 diabetes), regardless of the mode of administration (injection or pen).
What is the risk associated with Insulatard?
Like all insulins, Insulatard can cause hypoglycemia (reduced 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 are hypersensitive (allergic) to human insulin (DNAr) or to any of the excipients. It may be necessary to adjust the dose of Insulatard in case of concomitant intake of other medicines that may have an effect on the level of glucose in the blood (for the full list, see 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 in the treatment of diabetes. The committee therefore recommended the granting of the marketing authorization for Insulatard.
More information on Insulatard
On 7 October 2002, the European Commission issued an EU-wide marketing authorization for Insulatard to Novo Nordisk A / S. The marketing authorization was renewed on 7 October 2007.
The full version of the evaluation (EPAR) is found here.
Last updated: 10 - 2007
