diabetes drugs

Apidra - insulin glulisine

What is Apidra?

Apidra is a solution for injection that contains the active substance insulin glulisine. It is available in vials, cartridges and pre-filled disposable pens (OptiSet and SoloStar).

What is Apidra used for?

Apidra is used to treat patients over six years of age with diabetes when they need insulin.

The medicine can only be obtained with a prescription .

How is Apidra used?

Apidra is administered by subcutaneous injection into the abdominal wall (belly), thigh or shoulder, or by continuous infusion using an insulin pump. At each injection it is advisable to change the injection site to avoid changes to the skin (such as thickening) that can make insulin less effective than expected. To find the minimum effective dose it is necessary to regularly monitor the levels of glucose (sugar) in the patient's blood.

Apidra should be given up to 15 minutes before meals or immediately after meals. Apidra is a short-acting insulin that is used in combination with intermediate or prolonged insulins or with insulin analogues (modified forms of insulin). It can also be used in combination with antidiabetic medicines taken by mouth.

How does Apidra work?

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

The active ingredient of Apidra, insulin glulisine, is produced by a method known as "recombinant DNA technique", ie it is produced by a bacterium in which a gene (DNA) has been introduced that makes it able to produce the insulin glulisine.

Insulin glulisine differs slightly from human insulin. Thanks to this difference, insulin glulisine acts more quickly and the action has a shorter duration than short-acting human insulin. Replacement insulin acts in the same way as 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.

What studies have been carried out on Apidra?

Apidra, used in combination with a long-acting insulin, has been studied in patients with type 1 diabetes (in which the body is unable to produce insulin) in two studies comprising a total of 1, 449 adults and one study involving 572 children and adolescents aged between four and 17 years.

In type 2 diabetes (where the body is unable to use insulin effectively), Apidra was studied in a study involving 878 adults. In this study, Apidra was used in combination with an intermediate-acting insulin and with antidiabetic medicines taken by mouth.

In all four studies, Apidra was compared to other insulins or insulin analogues (normal human insulin or insulin lispro). The main efficacy index was the change in the levels of a substance present in the blood called glycosylated hemoglobin (HbA1c), which provides an indication of the level of efficacy of blood glucose control.

What benefit has Apidra shown during the studies?

Blood glucose control with Apidra was at least as effective as that obtained with comparative insulins. In all of the studies, the change in HbA1c level observed with Apidra was similar to that recorded with comparative insulins.

In the first study in adults with type 1 diabetes, after six months there was a decrease of 0.14% (from 7.60% to 7.46%) and of 0.14% with insulin lispro. Similar reductions were observed in the second study in adults, in which Apidra was compared to normal human insulin. In the study of children and adolescents, Apidra and insulin lispro caused similar changes in the level of HbA1c after six months. However, there was insufficient information to demonstrate whether Apidra was effective in children under the age of six.

In adults with type 2 diabetes, there was a 0.46% decrease in the level of HbA1c after six months of treatment with Apidra compared to 0.30% with normal human insulin.

What is the risk associated with Apidra?

The most common side effect with Apidra (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose). For the full list of all side effects reported with Apidra, see the Package Leaflet.

Apidra should not be used in people who may be hypersensitive (allergic) to insulin glulisine or any of the other ingredients. It must not be used in patients who already have hypoglycemia. It is also possible that doses of Apidra should be adjusted when administered with other medicines that can affect blood glucose levels. For the complete list, see the package leaflet.

Why has Apidra been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra's benefits are greater than its risks for the treatment of diabetes mellitus in adults, adolescents and children over the age of six, when treatment with insulin is needed. The Committee recommended that Apidra be given marketing authorization.

More information about Apidra:

On 27 September 2004, the European Commission issued a marketing authorization valid throughout the European Union to Sanofi-Aventis Deutschland GmbH for Apidra. The marketing authorization was renewed on 27 September 2009.

The full EPID for Apidra can be found here.

Last update of this summary: 09-2009.