Author: sanofi-aventis Deutschland GmbH


Long information

What is it?

Optisulin is a solution for injection that contains the active substance insulin glargine. It is available as vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Optisulin is used to treat patients aged six years or older with diabetes, when they need insulin.

The medicine can only be obtained with a prescription.

How is it used?

Optisulin is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected. The patient?s blood glucose (sugar) should be regularly tested to find the lowest effective dose.

Optisulin is given once a day. In adults (aged 18 years or over) it can be given at any time, provided that it is at the same time each day. It should be given in the evening in patients aged less than 18 years. Optisulin can also be given together with antidiabetes medicines taken by mouth in patients who have type 2 diabetes.

Patients can inject themselves with Optisulin if they have been trained appropriately.

How does it work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Optisulin is a replacement insulin that is very similar to the insulin made by the body.

The active substance in Optisulin, insulin glargine, is produced by a method known as ?recombinant DNA technology?: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glargine.

Insulin glargine is very slightly different from human insulin. The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has it been studied?

Optisulin was originally studied in 10 studies, in both type 1 diabetes (when the pancreas cannot produce insulin) and type 2 diabetes (when the body is unable to use insulin effectively). A total of 2,106 patients received Optisulin in all trials combined. The main studies compared Optisulin given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day. Injections of fast-acting insulin were also used at mealtimes. In one study, patients with type 2 diabetes also received antidiabetes medicines by mouth.

Further studies were carried out to compare Optisulin and human insulin NPH in patients aged between five and 18 years, 200 of whom received Optisulin. Studies were also carried out in nearly 1,400 adults with type 1 or type 2 diabetes to measure the effectiveness of Optisulin injected at any time during the day, compared with an injection given in the evening.

All of the studies measured the level of ?fasting? blood glucose (measured when the patient had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

What benefits has it shown during the studies?

Optisulin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin. Optisulin was effective for both type 1 and type 2 diabetes. However, there were too few children aged below six years to determine the medicine?s effectiveness in this group. The effectiveness of Optisulin was seen regardless of the time of the injection.

What is the risk associated?

The most common side effect with Optisulin (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults. For the full list of all side effects reported with Optisulin, see the Package Leaflet.

Optisulin should not be used in people who may be hypersensitive (allergic) to insulin glargine or to any of the other ingredients. Optisulin doses might also need to be adjusted when given with some other medicines that may have an effect on blood glucose levels. The full list is available in the Package Leaflet.

Why has it been approved?

The CHMP decided that Optisulin?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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