What is Insuman?
Insuman includes a series of injectable insulin solutions and suspensions. Insuman is available in vials, cartridges or prefilled disposable pens (OptiSet and SoloStar).
Insuman contains the active substance insulin human. The Insuman range includes fast-acting insulin solutions (Insuman Rapid and Insuman Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insuman Basal) that contains isophane insulin, and a combination of fast-acting insulin and insulin intermediate action in various proportions (Insuman Comb):
- Insuman Comb 15: 15% soluble insulin and 85% crystalline protamine insulin;
- Insuman Comb 25: 25% soluble insulin and 75% crystalline protamine insulin;
- Insuman Comb 30: 30% soluble insulin and 70% crystalline protamine insulin;
- Insuman Comb 50: 50% soluble insulin and 50% crystalline protamine insulin.
What is Insuman used for?
Insuman is indicated in patients with diabetes when treatment with insulin is needed.
Insuman Rapid is also suitable for the treatment of hyperglycemic coma (coma caused by an excessive level of glucose [sugar] in the blood), of ketoacidosis (high concentrations of ketones [acids] in the blood) and to obtain a stabilization of glucose in the blood before, after or during surgery.
The medicine can only be obtained with a prescription.
How is Insuman used?
Insuman is injected under the skin, usually in the abdominal wall (belly) or thigh, according to the doctor's recommendations. The injection sites must be rotated between one injection and the next. The expected blood glucose rate, the type of Insuman to be used, the dosage and the timing of administration are determined by the doctor for each individual patient and are adapted according to the patient's diet, physical activity and lifestyle. To find the minimum effective dosage it is necessary to monitor the patient's blood glucose level regularly. Insuman should be taken before meals. Please refer to the package leaflet for the correct administration times. Insuman Rapid can also be given into a vein, provided this is done in a hospital setting where the patient can be monitored closely. Insuman Infusat has been designed in special infusion pumps ready for use.
How does Insuman work?
Diabetes is a disease in which the body does not produce enough insulin to control blood glucose levels. Insuman is an insulin analogue, identical to the body's own insulin.
The active ingredient of Insuman, human insulin, is produced by a method known as "recombinant DNA technology": that is, it is obtained from a bacterium with a gene (DNA) that makes it capable of producing insulin. Insuman contains insulin in different forms: soluble insulin, which acts quickly (within 30 minutes of injection), and forms of isophane and crystalline protamine, which are absorbed much more slowly during the day giving them a longer lasting effect.
Replacement insulin acts exactly like natural insulin and promotes the penetration of glucose into 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 Insuman?
Insuman was studied in two trials of 611 patients with type 1 diabetes (in which the pancreas is unable to produce insulin) or type 2 diabetes (in which the body is unable to use the effectively insulin). In one of the two studies Insuman was used in an insulin pump. In the other study, Insuman Comb 25 was compared with semi-synthetic human insulin. These studies measured the fasting concentration of glucose in the blood (measured when patients had been fasting for at least eight hours) or of a substance in the blood called glycosylated hemoglobin (HbA1c) that gives an indication of the effectiveness of blood glucose control . The studies also examined the number of patients who had developed hypoglycemia (low blood glucose concentrations).
What benefit has Insuman shown during the studies?
Insuman induced a decrease in the level of HbA1c, demonstrating that blood glucose concentrations were maintained at a level similar to that guaranteed by human semi-synthetic insulin. Insuman was effective in both type 1 diabetes and type 2 diabetes.
What is the risk associated with Insuman?
Insuman may cause hypoglycaemia. For the full list of all side effects reported with Insuman, see the Package Leaflet.
Insuman must not be used in people who may be hypersensitive (allergic) to human insulin or any of the other ingredients. Insuman doses may need to be adjusted in case of concomitant intake of other medicines which may have an effect on the blood glucose level. For a complete list of these medicines, see the package leaflet.
Why has Insuman been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Insuman's benefits are greater than its risks for the treatment of diabetes mellitus. The Committee recommended that Insuman be given marketing authorization.
More information on Insuman
On 21 February 1997 the European Commission issued a marketing authorization valid throughout the European Union for Insuman to Sanofi-Aventis Deutschland GmbH. The marketing authorization was renewed on 21 February 2002 and 21 February 2007.
The full EPAR for Insuman can be found here.
Last update of this summary: 12-2008
