Tresiba - Insulin degludec
What is Tresiba - Insulin degludec?
Tresiba is a medicine that contains the active substance insulin degludec. It is available as a solution for injection in cartridge (100 units / ml) and in pre-filled pen (100 units / ml and 200 units / ml).
What is Tresiba - Insulin degludec used for?
Tresiba is used to treat type 1 and type 2 diabetes in adults.
The medicine can only be obtained with a prescription.
How is Tresiba - Insulin degludec used?
Tresiba should be administered once a day, preferably at the same time each day. The medicine is administered subcutaneously by injection into the thigh, upper arm or abdominal wall. The injection areas must always be alternated within the same area to reduce the risk of lipodystrophy (alterations in the distribution of the body's adipose tissue) at the subcutaneous level, which can interfere with the amount of Tresiba absorbed by the body.
The correct dose should be determined according to the individual needs of the patients. In type 1 diabetes, Tresiba should always be used in combination with a "fast-acting insulin, which is given by injection during meals. In type 2 diabetes, Tresiba can be used alone, in combination with other antidiabetic medicines and with fast-acting mealtime insulin (taken with meals).
How does Tresiba - Insulin degludec work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or is unable to use insulin effectively. Tresiba is a replacement insulin very similar to natural insulin with the difference that it is absorbed much more slowly in the body and takes longer to reach its target. This means that Tresiba has a long duration of action. Tresiba acts like naturally produced insulin and contributes to the penetration of glucose into cells from the blood. By controlling the blood glucose level, it reduces the symptoms and complications of diabetes.
How has Tresiba - Insulin degludec been studied?
The effects of Tresiba were first tested in experimental models before being studied in humans.
Tresiba has been studied in three main studies involving 1,578 patients with type 1 diabetes and six main studies involving 4,076 patients with type 2 diabetes. type 1 Tresiba was compared with insulin glargine or insulin detemir (other long-acting insulins). Patients were also given fast-acting mealtime insulin. In the type 2 diabetes studies, Tresiba was compared with insulin glargine, insulin detemir or sitagliptin (an oral medicine for type 2 diabetes); patients could also take other diabetes medications or fast-acting mealtime insulin as needed.
All of the studies measured the blood concentration of a substance in the blood called glycosylated hemoglobin (HbA1c), which is the percentage of hemoglobin in the blood that binds to glucose. HbA1c gives an indication of the effectiveness of blood glucose control. Three studies lasted one year, six were conducted over six months.
What benefit has Tresiba - Insulin degludec shown during the studies?
Studies have shown that Tresiba is at least as effective as other long-acting insulins in controlling blood glucose levels in patients with type 1 and type 2 diabetes, and is more effective than sitagliptin in patients with type 2 diabetes. 2. In the study, the mean reduction in HbA1c levels with Tresiba treatment was 0.6% in patients with type 1 diabetes and 1.2% in patients with type 2 diabetes.
What is the risk associated with Tresiba - Insulin degludec?
The most common side effect of Tresiba is hypoglycaemia (low blood glucose levels).
Tresiba must not be used in people who are hypersensitive (allergic) to insulin degludec or any of the other ingredients.
Why has Tresiba - Insulin degludec been approved?
The CHMP decided that Tresiba is effective in controlling blood glucose levels in patients with type 1 and type 2 diabetes. Regarding its safety, the Committee concluded that, in general, Tresiba is safe and that its side effects are comparable to those of other insulin analogues, for which no unexpected side effects are reported. Tresiba was also found to reduce the risk of hypoglycaemia at night in patients with type 1 and type 2 diabetes. The CHMP noted that the higher strength formulation of Tresiba addresses a "medical need of patients who require a higher dose of insulin (for example, overweight individuals) and considered that it could allow these patients to take their daily dose corrected without the need for two injections. However, the CHMP also concluded that measures are needed to provide more information on the new dosage and reduce the risk of medication errors due to unfamiliarity with the medicine. The CHMP decided that Tresiba's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
What measures are being taken to ensure the safe use of Tresiba - Insulin degludec?
The company that markets Tresiba will provide educational material to healthcare professionals who are expected to administer or prescribe the medicines to patients with diabetes, in particular to make them aware of the high-dose formulation of Tresiba. It will also produce educational material to instruct patients on the correct use of Tresiba, which should be provided by the treating physician along with appropriate training.
Other information about Tresiba - Insulin degludec
On 21 January 2013, the European Commission issued a "marketing authorization" for Tresiba, valid throughout the European Union.
For more information about Tresiba therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 01-2013.
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