What is Lantus?
Lantus is a clear solution for injection containing the active substance insulin glargine. It is available in vials, cartridges and pre-filled disposable pens (OptiSet and SoloStar).
What is Lantus used for?
Lantus is used to treat adults, adolescents and children from six years of age with diabetes when they need insulin.
The medicine can only be obtained with a prescription .
How is Lantus used?
Lantus is given as an injection under the skin in the abdominal wall (belly), in the thigh or in the deltoid region (shoulder). At each injection it is advisable to vary the injection site to avoid changes to the skin (such as thickening) that may be the cause of a lower insulin activity than expected. To find the minimum effective dosage the level of glucose (sugar) in the patient's blood must be regularly monitored.
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 due to the fact that the body does not produce enough insulin to control the level of glucose in the blood. Lantus is a replacement insulin very similar to the insulin produced by the body.
The active ingredient of Lantus, insulin glargine, is produced by a method known as "recombinant DNA technique": that is, it is obtained from a bacterium that receives a gene (DNA), which makes it capable of producing 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 the injection and that its action is long lasting. 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.
What studies have been carried out on Lantus?
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 the studies performed. The main studies compared Lantus, given once a day before bedtime, and human insulin NPH (an intermediate-acting insulin) given once or twice a day. Fast-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 performed to compare Lantus and human insulin NPH in children and adolescents between the ages of five and 18, of whom 200 were given Lantus. Studies were also carried out on 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 with an evening injection. All studies measured the level of "fasting" blood glucose (measured after at least eight hours of fasting) or a substance in the blood called glycosylated hemoglobin (HbA1c), which provides an indication of the level of efficacy of glucose control in the blood.
What benefit has Lantus shown during the studies?
Lantus induced a decrease in the level of HbA1c, indicating that blood glucose levels were maintained at a similar level to that observed 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 efficacy of the drug in this group. The efficacy of Lantus did not vary according to the time of administration.
What is the risk associated with Lantus?
The most common side effect with Lantus (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Injection site reactions (redness, pain, itching and swelling) have been observed more often in children than in adults. For the full list of all side effects reported with Lantus, see the Package Leaflet.
Lantus should not be used in people who may be hypersensitive (allergic) to insulin glargine or any of the other ingredients. Doses of Lantus may need to be adjusted when given with some other medicines that can affect blood glucose levels. For the complete list, see the 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 insulin treatment is needed. The Committee recommended that Lantus be given marketing authorization.
More information on Lantus:
On 9 June 2000, the European Commission granted a marketing authorization for Lantus, valid throughout the European Union, to Sanofi-Aventis Deutschland GmbH. The marketing authorization was renewed on 9 June 2005.
For the full EPAR for Lantus, click here.
Last update of this summary: 03-2009.
