What is Xultophy - insulin degludec, liraglutide?
Xultophy is a medicine indicated for the treatment of type 2 diabetes. It is used in combination with anti-diabetic medicines taken by mouth in adult patients whose blood glucose (sugar) levels are not adequately controlled by these medicines alone or in combination with insulin. The active ingredients of Xultophy are insulin degludec and liraglutide .
How is Xultophy used - insulin degludec, liraglutide?
Xultophy is available as pre-filled disposable pens and can only be obtained with a prescription. It is given by subcutaneous injection in the thigh, upper arm or abdominal wall. Each injection should vary the injection site to avoid skin changes (including thickening) that can reduce the action of the medicine compared to what is expected. The injection of Xultophy can be done by the patient himself, provided he has received appropriate instructions. Xultophy is given once a day, preferably at the same time. The dose is adjusted individually for each patient. To find the minimum effective dosage the blood glucose level of the patient must be regularly monitored. For more information, see the package leaflet.
How does Xultophy - insulin degludec, liraglutide work?
Type 2 diabetes is a disease in which the body does not produce enough insulin to control blood glucose levels or is unable to use insulin effectively. One of the active ingredients present in Xultophy, insulin degludec, is a replacement insulin that has the same mechanisms of action as naturally produced insulin and promotes the penetration of glucose into blood cells. By controlling the level of glucose in the blood, it reduces the symptoms and complications of diabetes. Insulin degludec is only slightly different from human insulin, since after injection it is absorbed more slowly and more regularly by the body and has a prolonged duration of action. The other active ingredient present in Xultophy, liraglutide, is an "incretino-mimetic". This means that it acts in the same way as incretin, a hormone produced in the intestine, inducing an increase in the level of insulin released by the pancreas in response to food intake. In this way it helps control blood glucose levels. Insulin degludec and liraglutide present in Xultophy are produced by a method known as "recombinant DNA technology": that is, they are obtained from bacteria in which a gene (DNA) has been inserted that makes them able to produce the active ingredient.
What benefit has Xultophy - insulin degludec, liraglutide shown during the studies?
Once-daily administration of Xultophy has been shown to be effective in blood glucose control in two main studies involving 2 076 patients with type 2 diabetes. In both studies the main measure of effectiveness was the change, after 6 months of treatment, of the concentration in the blood of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the efficacy of blood glucose control.
- The first study was conducted on 1, 663 patients with diabetes not adequately controlled with the antidiabetic medicines metformin or metformin and pioglitazone taken by mouth: the addition of Xultophy to the therapy was compared with the addition of either its active ingredients, insulin degludec or liraglutide. The mean HbA1c level, which was initially 8.3%, fell to 6.4% after 26 weeks of Xultophy treatment compared to 6.9% and 7.0% in the insulin degludec groups and liraglutide.
- The second study involved 413 patients in whom blood glucose was not adequately controlled with the combination of insulin and metformin, in association or not with other oral antidiabetic medicines. Xultophy and metformin therapy was compared with insulin degludec and metformin treatment. The average level of HbA1c, which was initially 8.7% in the group treated with Xultophy, after 26 weeks of treatment fell to 6.9%. In the comparison group it decreased from 8.8% to 8.0%.
In most of the subjects treated with Xultophy in these studies it was possible to control blood glucose (ie HbA1c target levels were reached below 7.0%) and in many cases an HbA1c level was reached less than 6.5%. The studies also examined other effects of therapy, including the impact on body weight; the latter generally remained stable or slightly decreased in patients treated with Xultophy, while it showed a tendency to increase in subjects treated with insulin degludec and to decrease in those treated with liraglutide.
What is the risk associated with Xultophy - insulin degludec, liraglutide?
The most common side effect of Xultophy (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels). Side effects have also been observed in the digestive system, which may affect up to 1 in 10 people and include nausea, diarrhea, vomiting, constipation, dyspepsia (indigestion), gastritis (inflammation of the stomach), abdominal pain (stomach pain ), flatulence, gastroesophageal reflux (gastric acid rise to the oral cavity) and distention (swelling) of the abdomen. For the full list of all side effects and restrictions with Xultophy, see the package leaflet.
Why has Xultophy - insulin degludec, liraglutide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xultophy's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee noted that combining this medicinal product with other diabetic medicines allowed better control of blood glucose, with a lower risk of weight gain, than the addition of insulin degludec alone, despite the higher risk of undesirable effects borne by the digestive system. Compared to the addition of liraglutide only, Xultophy was associated with a greater reduction in HbA1c and a lower reduction in body weight. Being able to have alternative therapy was considered important for adapting the treatment to individual needs.
What measures are being taken to ensure the safe and effective use of Xultophy - insulin degludec, liraglutide?
A risk management plan has been developed to ensure that Xultophy 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 Xultophy, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Xultophy will provide information material to healthcare professionals explaining how to use the medicine safely to reduce the risk of medication errors. Further information is available in the summary of the risk management plan.
Other information about Xultophy - insulin degludec, liraglutide
On 18 September 2014, the European Commission issued a marketing authorization for Xultophy, valid throughout the European Union. For more information about treatment with Xultophy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2014.
