What is Levemir?
Levemir is a solution for injection that contains the active substance insulin detemir. It is available in cartridges (PenFill) and pre-filled pens (FlexPen and InnoLet).
What is Levemir used for?
Levemir is used to treat adults, adolescents and children over 6 years of age with diabetes.
The medicine can only be obtained with a prescription.
How is Levemir used?
Levemir is given by injection under the skin in the abdominal wall (belly), in the thighs, in the upper part of the arms, in the shoulders or in the buttocks. Levemir is a long-acting insulin that can be used in the following ways:
- once a day in combination with oral anti-diabetic medicines. It can be administered at any time of the day, provided that the time is the same every day. Levemir dose should be adjusted depending on the glucose (sugar) levels present in each patient's blood;
- in combination with injections of a short-acting or rapid-acting insulin during meals. Levemir should be given once or twice a day, depending on the patient's needs.
The patient's blood glucose level must be checked regularly to find the minimum effective dose.
How does Levemir work?
Diabetes is a disease due to the fact that the body does not produce enough insulin to control the level of glucose in the blood. Levemir is a replacement insulin very similar to that produced by the body. The active substance in Levemir, insulin detemir, is produced by a method known as "recombinant DNA technology": it is obtained from a yeast enriched with a gene (DNA) that makes it able to produce insulin detemir.
Insulin detemir is slightly different from human insulin. This difference involves its slower absorption into the body with longer times to reach the target in the body, which implies that Levemir has a long-lasting action. Replacement insulin acts like naturally produced insulin and helps glucose penetrate cells from the blood. By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.
How has Levemir been studied?
Levemir has been studied in 1575 patients with type 1 diabetes (in which the pancreas is unable to produce insulin) and over 2 400 patients with type 2 diabetes (in which the body is unable to use the effectively insulin). These studies compared Levemir to human insulin NPH (an intermediate-acting insulin) or insulin glargine (a long-acting insulin) given once or twice a day. Rapid-acting insulin injections were also performed at meal times. In four of the six type 2 diabetes studies, patients were also given one or two oral antidiabetic drugs. All studies measured the level of a substance present in the blood, called glycosylated hemoglobin (HbA1c), which gives an indication of the effectiveness of blood glucose control. Levemir has not been studied in children younger than six years.
What benefit has Levemir shown during the studies?
Studies have revealed that Levemir controls blood glucose levels in a manner similar to NPH insulin, with less risk of low blood glucose levels overnight and without weight gain. Associated with orally administered antidiabetic drugs, Levemir also controlled blood glucose levels similarly to insulin glargine.
What is the risk associated with Levemir?
The most common side effects seen with Levemir (seen between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels) and reactions at the injection site (pain, redness, rash, inflammation, skin bruising, swelling and itching ). For patients also taking oral antidiabetic drugs, signs of allergy are found even between 1 and 10 patients in 100. For the full list of all side effects reported with Levemir, see the Package Leaflet.
Levemir should not be used in patients who may be hypersensitive (allergic) to insulin detemir or any of the other ingredients. Levemir doses must be adjusted when given with some other medicines that may have an effect on blood glucose levels. The complete list is available in the package leaflet.
Why has Levemir been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Levemir's benefits for the treatment of diabetes mellitus are greater than its risks. The Committee therefore recommended that Levemir be given marketing authorization.
More information on Levemir
On 1 June 2004, the European Commission issued a marketing authorization valid throughout the European Union for Levemir to Novo Nordisk A / S. The marketing authorization was renewed on 1 June 2009.
For the full EPAR of Levemir, click here.
Last update of this summary: 06-2009
