What is Optisulin?
Optisulin 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 Optisulin used for?
Optisulin is used to treat adults, adolescents and children from six years of age with diabetes, when insulin treatment is required.
The medicine can only be obtained with a prescription.
How is Optisulin used?
Optisulin is given by 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 serum glucose (sugar) level should be regularly monitored.
Optisulin is given once a day at any time, as long as it is the same time each day. In children this should happen in the evening. In patients with non-insulin-dependent diabetes (type 2 diabetes), Optisulin can be given with oral antidiabetic drugs.
How does Optisulin 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. Optisulin is an insulin analogue very similar to the insulin produced by the body.
The active ingredient of Optisulin, insulin glargine, is produced by a method known as "recombinant DNA technique": that is, it is obtained from a bacterium with a gene (DNA) that 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 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 Optisulin?
Originally Optisulin was studied in 10 studies, both for type 1 and type 2 diabetes. In all the studies carried out, a total of 2 106 patients were treated with Optisulin. The main studies compared Optisulin administered once a day (at bedtime) with 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 oral antidiabetic drugs.
Additional studies have been performed to compare Optisulin and human insulin NPH in children and adolescents between the ages of five and 18, of whom 200 were given Optisulin. Studies were also performed on 1, 400 adult patients with type 1 or type 2 diabetes to measure the efficacy of Optisulin injected at any time of day and compared with an evening injection.
All studies measured the level of fasting blood glucose (measured when the patient had not absorbed food for at least eight hours) or a substance in the blood called glycosylated hemoglobin (HbA1c), which provides an indication of the effectiveness of the control of glucose in the blood.
What benefit has Optisulin shown during the studies?
Optisulin induced a decrease in the level of HbA1c, demonstrating that blood glucose levels were maintained at a level similar to that guaranteed by human insulin. Optisulin was effective in both type 1 diabetes 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 Optisulin did not vary according to the time of administration.
What is the risk associated with Optisulin?
The most common side effect of Optisulin (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 Optisulin, see the Package Leaflet.
Optisulin must not be used in people who are hypersensitive (allergic) to insulin glargine or to any of the excipients. It may be the case that doses of Optisulin should be adjusted when given concurrently with other medicines that can affect blood glucose levels. The complete list is shown in the package leaflet.
Why has Optisulin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Optisulin'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 the granting of the marketing authorization for Optisulin.
More information on Optisulin
On 27 June 2000, the European Commission granted a marketing authorization valid for Optisulin throughout the European Union to Sanofi-Aventis Deutschland GmbH. The marketing authorization was renewed on 27 June 2005.
For the full version of the optisulin evaluation (EPAR), click here. Last update of this summary: 02-2009
