Active Substance: insulin degludec
Common Name: insulin degludec
ATC Code: A10AE06
Marketing Authorisation Holder: Novo Nordisk A/S
Active Substance: insulin degludec
Authorisation Date: 2013-01-21
Therapeutic Area: Diabetes Mellitus
Pharmacotherapeutic Group: Drugs used in diabetes
Treatment of diabetes mellitus in adults.
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 pre‑filled 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 or in combination with oral diabetes medicines, GLP‑1 receptor agonist medicines and 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 cells into which a gene (DNA) has been introduced, which makes them 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?
Tresiba has been studied in three main studies involving 1,578 patients with type 1 diabetes, where Tresiba (in combination with rapid acting mealtime insulin) was compared with insulin glargine or insulin detemir (other long acting insulins).
Six other main studies involving 4,076 patients with type 2 diabetes compared Tresiba with insulin glargine, insulin detemir or sitagliptin (a medicine taken by mouth for type 2 diabetes). Patients in these studies could also be given other diabetes medicines or rapid-acting insulin at mealtimes if needed. Another main study involving 177 patients with type 2 diabetes investigated the effectiveness of combining Tresiba and liraglutide (a GLP‑1 receptor agonist).
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. Studies lasted for six months or one year.
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 percentage points in patients with type 1 diabetes and 1.2 points in patients with type 2 diabetes.
What is the risk associated with Tresiba?
The most frequently reported side effect during treatment with Tresiba (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
For the full list of side effects and restrictions with Tresiba, see the package leaflet.
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?
A risk management plan has been developed to ensure that Tresiba is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tresiba, including the appropriate precautions to be followed by healthcare professionals and patients.
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 in order to ensure that the patient is prescribed the correct strength. 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.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.