Xultophy - insulin degludec, liraglutide

What is Xultophy and what is it used for - insulin degludec, liraglutide?

Xultophy is a medicine indicated for the treatment of type 2 diabetes. It is used in combination with antidiabetic 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 substances in Xultophy are insulin degludec and liraglutide.

How is Xultophy used - insulin degludec, liraglutide?

Xultophy is available as single-use pre-filled pens and can only be obtained with a prescription. It is given by injection under the skin in the thigh, upper arm or abdominal wall. It is advisable to vary the injection site with each administration to avoid skin changes (including thickening) which may reduce the action of the medicine compared to what is expected. The injection of Xultophy can be given by the patient himself, provided he has received appropriate instructions. Xultophy is administered once a day, preferably at the same time. The dose is adjusted individually for each patient. To find the minimum effective dosage it must be regularly monitored. the patient's blood glucose level See package leaflet for further information.

How does Xultophy work - insulin degludec, liraglutide?

Type 2 diabetes is a disease in which the body does not make enough insulin to control blood glucose levels or is unable to use insulin effectively. One of the active ingredients 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 blood glucose levels. Symptoms and Complications of Diabetes. Insulin degludec is only slightly different from human insulin in that, after injection, it is absorbed more slowly and more regularly by the body and has a longer duration of action. The other active ingredient present in Xultophy, liraglutide, is an “incretin-mimetic”. This means that it acts in the same way as incretin, a hormone produced in the intestine, causing 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 The degludec and liraglutide in Xultophy are produced by a method known as 'recombinant DNA technology': they are made by bacteria that have received a gene (DNA), which makes them able to produce the active substance.

What benefit has Xultophy - insulin degludec, liraglutide shown during the studies?

Once-daily administration of Xultophy was shown to be effective in controlling blood glucose 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. treatment, the concentration in the blood of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the effectiveness of blood glucose control.

  • The first study was conducted in 1,663 patients with diabetes inadequately controlled with the antidiabetic medicines metformin or metformin and pioglitazone taken by mouth: the addition of Xultophy to 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 treatment with Xultophy compared to 6.9% and 7.0% in the insulin degludec and insulin degludec groups, respectively. liraglutide.
  • The second study involved 413 patients whose blood glucose was not adequately controlled with the combination of insulin and metformin, whether or not with other antidiabetic medicines taken by mouth. Xultophy and metformin therapy was compared with insulin degludec and metformin treatment. The mean HbA1c level, which was initially 8.7% in the Xultophy group, fell to 6.9% after 26 weeks of treatment. In the comparison group it decreased from 8.8% to 8.0%.

In most of the subjects treated with Xultophy in these studies, blood glucose could be controlled (ie target HbA1c levels below 7.0% were achieved) and in many cases an HbA1c level was achieved. less than 6.5%.The studies also looked at other effects of therapy, including impact on body weight; the latter generally remained stable or slightly decreased in patients treated with Xultophy, while it tended to increase in patients 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 with Xultophy (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels). Side effects affecting the digestive system have also been observed, 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 (ascent of gastric acid towards the mouth) and distension (swelling) of the abdomen. For the full list of side effects and limitations reported 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 the combination of this medicine with other diabetic medicines, it allowed to obtain a better control of blood glucose, with a lower risk of weight gain, compared to the addition of insulin degludec alone, despite the higher risk of undesirable effects affecting the digestive system. liraglutide alone, Xultophy was associated with a greater reduction in HbA1c and less reduction in body weight. The availability of alternative therapy was considered important for adapting 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 added to the summary of product characteristics and 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 educational material to healthcare professionals explaining how to use the medicine safely in order to reduce the risk of medication errors. Further information can be found in the summary of the risk management plan.

Other information about Xultophy - insulin degludec, liraglutide

On 18 September 2014, the European Commission granted a "Marketing Authorization" for Xultophy, valid throughout the European Union. For more information on Xultophy therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 09-2014.


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