Lantus - insulin glargine
What is Lantus?
Lantus is a clear solution for injection that contains the active substance insulin glargine. It is available in vials, cartridges and disposable pre-filled pens (OptiSet and SoloStar).
What is Lantus used for?
Lantus is used to treat diabetes in adults, adolescents and children from six years of age when they need insulin.
The medicine can only be obtained with a prescription.
How is Lantus used?
Lantus is given by injection under the skin in the abdominal wall (belly), thigh or deltoid region (shoulder). At each injection it is advisable to vary the injection site to avoid skin changes (such as thickening) which may be at the origin of a lower insulin activity than expected. To find the minimum effective dosage, the level of insulin should be regularly monitored. glucose (sugar) in the patient's blood.
Lantus is given once a day at any time, but at the same time every day. In children this should happen in the evening. In patients with non-insulin-dependent diabetes (type 2 diabetes), Lantus can also be given together with antidiabetic medicines taken by mouth.
How does Lantus work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood. Lantus is a "replacement insulin that is very similar to the insulin produced by the body".
The active substance in Lantus, insulin glargine, is produced by a method known as the 'recombinant DNA technique': it is made by a bacterium that receives a gene (DNA), which makes it able to produce insulin glargine.
Insulin glargine is slightly different from human insulin. This difference implies that it is absorbed more slowly and regularly by the body after injection and that its action is long lasting. Replacement insulin acts like naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.
How has Lantus been studied?
Lantus was initially studied in 10 studies, both in patients with type 1 diabetes and in patients with type 2 diabetes. A total of 2 106 patients were treated with Lantus in all studies. The main studies compared Lantus, given once a day at bedtime, and human insulin NPH (an "intermediate-acting" insulin) given once or twice a day. Rapid-acting insulin injections were also used during meals. In one study, patients with type 2 diabetes also received antidiabetic drugs by mouth.
Additional studies were carried out to compare Lantus and human NPH insulin in children and adolescents between five and 18 years of age, 200 of whom were given Lantus. Studies in 1,400 adult patients with type 1 or type 2 diabetes, to measure the effectiveness of Lantus injected at any time of day and compared to an "evening injection. All studies measured the" fasting "blood glucose level (measured after at least eight hours of fasting) or a substance in the blood called glycosylated hemoglobin (HbA1c), which gives an "indication of how well the blood glucose is controlled.
What benefit has Lantus shown during the studies?
Lantus induced a drop in the level of HbA1c, indicating that blood glucose levels were being maintained at a level similar to that seen with human insulin. Lantus was effective in both type 1 and type 2 diabetes. However, children under the age of six were not numerous enough to determine the drug's effectiveness in this group. The efficacy of Lantus did not vary based on time of administration.
What is the risk associated with Lantus?
The most common side effect seen with Lantus (seen in more than 1 in 10 patients) is hypoglycaemia (low blood glucose levels). Reactions at the injection site (redness, pain, itching and swelling) were seen more often in children than in adults. For the full list of side effects reported with Lantus, see the package leaflet.
Lantus must not be used in people who are hypersensitive (allergic) to insulin glargine or any of the other ingredients. The doses of Lantus may need to be adjusted when given with certain other medicines which can affect blood glucose levels. full list, see package leaflet.
Why has Lantus been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Lantus's benefits are greater than its risks for the treatment of diabetes mellitus in adults, adolescents and children aged six years and above where treatment with insulin is required. The committee recommended the granting of a marketing authorization for Lantus.
Other information about Lantus:
On 9 June 2000, the European Commission granted Sanofi-Aventis Deutschland GmbH a "Marketing Authorization" for Lantus, valid throughout the European Union. The "Marketing Authorization" was renewed on 9 June 2005.
For the full version of the Lantus EPAR, click here.
Last update of this summary: 03-2009.
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