This is a summary of the European public assessment report (EPAR) for Tresiba. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tresiba.
- What is Tresiba?
Tresiba is a medicine that contains the active substance insulin degludec. It is available as a solution for injection in a cartridge (100 units/ml) and in a prefilled pen (100 units/ml and 200 units/ml).
- What is Tresiba 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 used?
Tresiba is injected once per day, preferably at the same time every day. It is given as an injection under the skin in the thigh, upper arm or abdominal wall (at the front of the waist). The place within the chosen area should be altered with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of Tresiba absorbed.
The correct dose is determined individually for each patient. In type-1 diabetes, Tresiba must always be used in combination with rapid acting insulin, which is injected at mealtimes. In type-2 diabetes, Tresiba can be used alone, in combination with other diabetes medicines and with rapid-acting mealtime insulin.
- How does Tresiba work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively. Tresiba is a replacement insulin that is very similar to the insulin made by the body.
The active substance in Tresiba, insulin degludec, is produced by a method known as ‘recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes the yeast able to produce it.
Insulin degludec is slightly different from human insulin. The difference means that it is absorbed more slowly by the body, and takes longer to reach its target in the body. This means that Tresiba has a long duration of action. The replacement insulin acts in the 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 Tresiba 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 in six main studies involving 4,076 patients with type-2 diabetes. The studies in type-1 diabetes compared Tresiba with insulin glargine or insulin detemir (other long-acting insulins). Patients also received injections of rapid-acting insulin at mealtimes. In the studies in type-2 diabetes Tresiba was compared with insulin glargine, insulin detemir or sitagliptin (a medicine taken by mouth for type-2 diabetes) and patients could also be given other diabetes medicines or rapid-acting insulin at mealtimes if needed.
All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose. HbA1c gives an indication of how well the blood glucose is controlled. Three of the studies lasted one year, while six of the studies lasted six months.
- What benefit has Tresiba shown during the studies?
The studies showed that Tresiba was at least as effective as other long acting insulins in controlling blood glucose levels in patients with type-1 and type-2 diabetes, and more effective than sitagliptin in patients with type-2 diabetes. Across the studies, the average 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?
The most frequently reported side effect during treatment with 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 been approved?
The CHMP concluded 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 Tresiba is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported. It also noted that Tresiba reduces the risk of hypoglycaemia during the night in patients with type-1 and type-2 diabetes.
The CHMP noted that the higher strength formulation of Tresiba met a medical need for patients requiring higher dose insulin (such as overweight patients), and considered that it could allow these patients to take the correct daily dose without double injections. However the CHMP also concluded that measures are needed to increase awareness of the new strength and reduce the risk of medication errors due to unfamiliarity.
The CHMP decided that Tresiba’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- What measures are being taken to ensure the safe use of Tresiba?
The company that markets Tresiba will provide educational materials to healthcare professionals expected to treat or dispense medicines to patients with diabetes, aimed particularly at raising awareness of the higher strength formulation of Tresiba. It will also produce educational materials for patients on how to use Tresiba correctly, which they should receive through their doctor together with suitable training.
- Other information about Tresiba
The European Commission granted a marketing authorisation valid throughout the European Union for Tresiba on 21 January 2013.
For more information about treatment with Tresiba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 20/02/2013 .
21/01/2013 Tresiba -EMEA/H/C/002498 --
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Treatment of diabetes mellitus in adults.
Changes since initial authorisation of medicine
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Initial marketing-authorisation documents
This medicine is approved for use in the European Union