Xultophy可作为预先填充的一次性笔使用，并且只能通过处方获得。 它在大腿皮肤，上臂或腹部（腹部）下注射。 每次注射时应改变注射部位，以避免皮肤变化（如增厚），使药物的效果低于预期。 如果他们接受过适当的训练，患者可以注射Xultophy。

每天给予一次Xultophy，优选每天在同一时间给予。 对每位患者单独调整剂量，并定期测试患者的血糖以找到最低有效剂量。

有关使用Xultophy的更多信息，请参阅包装说明书或联系您的医生或药剂师。

2型糖尿病是一种疾病，其中身体不能产生足够的胰岛素来控制血糖水平，或者身体无法有效地使用胰岛素。 Xultophy中的一种活性物质，即胰岛素degludec，是一种替代胰岛素，其作用方式与天然产生的胰岛素相同，并帮助葡萄糖从血液中进入细胞。 通过控制血糖水平，降低了糖尿病的症状和并发症。 胰岛素degludec与人胰岛素略有不同，因为它在注射后被身体更慢地和有规律地吸收并且它长时间起作用。

利拉鲁肽（Xultophy）中的另一种活性物质属于称为GLP-1激动剂的糖尿病药物。 它通过增加胰腺在响应食物时释放的胰岛素量，以与肠促胰岛素（肠道中产生的激素）相同的方式起作用。 这有助于控制血糖水平。

在涉及2,514名2型糖尿病患者的三项主要研究中，每日一次注射Xultophy已被证明有利于控制血糖。在所有研究中，有效性的主要衡量标准是在一种叫做糖基化血红蛋白（HbA1c）的物质的血液水平治疗6个月后的变化，这表明血糖控制得有多好。

第一项研究涉及1,663例糖尿病药物二甲双胍或口服二甲双胍和吡格列酮未能充分控制糖尿病的患者。将Xultophy加入其治疗组合中，加入其活性物质，胰岛素degludec或利拉鲁肽。开始时平均HbA1c水平为8.3％，在用Xultophy治疗26周后降至6.4％，而胰岛素degludec和利拉鲁肽分别为6.9％和7.0％。

第二项研究涉及413名患者，其血糖未通过胰岛素和二甲双胍充分控制，有或没有口服其他糖尿病药物。将使用Xultophy和二甲双胍的治疗与使用胰岛素degludec和二甲双胍的治疗进行比较。 Xultophy组起始时的平均HbA1c为8.7％，治疗26周后下降至6.9％。在使用胰岛素degludec的组中，它从8.8％下降到8.0％。

第三项研究涉及438名患者，其血糖未通过GLP-1激动剂（利拉鲁肽或艾塞那肽）和二甲双胍的组合得到充分控制，有或没有口服其他糖尿病药物。研究中的患者要么继续他们目前的治疗，要么接受Xultophy而不是GLP-1激动剂。患者开始接受Xultophy前平均HbA1c为7.8％，治疗26周后下降至6.4％。在继续接受GLP-1激动剂的组中，它从7.7％下降到7.4％。

在这些研究中，大多数接受Xultophy治疗的患者实现了血糖控制（HbA1c低于7.0％），许多患者的HbA1c低于6.5％。

Xultophy最常见的副作用（可能影响10人中超过1人）是低血糖（低血糖）。 消化系统的副作用发生在10名患者中，包括恶心（感觉不适），腹泻，呕吐，便秘，消化不良（消化不良），胃炎（胃部炎症），腹痛（胃痛），胃肠胀气（ 风），胃食管反流病（胃酸回流到口腔）和腹胀（肿胀）。 有关Xultophy的副作用和限制的完整列表，请参阅包装说明书。

欧洲药品管理局认定，Xultophy的好处大于其风险，可以授权在欧盟使用。将该药添加到其他糖尿病药物中可以更好地控制血糖，并且在个体化治疗中使用替代治疗选择是有价值的。

销售Xultophy的公司将为医疗保健专业人员提供教育材料，解释如何安全使用药物，以减少用药错误的风险。

医疗专业人员和患者为安全有效地使用Xultophy而应遵循的建议和预防措施也已包含在产品特性摘要和包装说明书中。

至于所有药物，持续监测关于使用Xultophy的数据。对Xultophy报告的副作用进行了仔细评估，并采取了任何必要的措施来保护患者。

关于Xultophy的其他信息

Xultophy于2014年9月18日获得了在整个欧盟有效的上市许可。

Xultophy

insulin degludec / liraglutide  

How is Xultophy used?

Xultophy is available as pre-filled disposable pens and can only be obtained with a prescription. It is given as an injection under the skin of the thigh, the upper arm or the abdomen (belly). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the medicine work less well than expected. Patients can inject themselves with Xultophy if they have been trained appropriately.

Xultophy is given once a day, preferably at the same time each day. The dose is adjusted individually for each patient, and the patient’s blood glucose should be regularly tested to find the lowest effective dose.

For more information about using Xultophy, see the package leaflet or contact your doctor or pharmacist.

How does Xultophy work?

Type 2 diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose, or the body is unable to use insulin effectively. One of the active substances in Xultophy, insulin degludec, is a replacement insulin that 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. Insulin degludec is slightly different from human insulin as it is absorbed more slowly and regularly by the body after an injection and it works for a long time.

The other active substance in Xultophy, liraglutide, belongs to the class of diabetes medicines known as GLP-1 agonists. It acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels.

What benefits of Xultophy have been shown in studies?

Once-daily injection of Xultophy has been shown to be of benefit in controlling blood glucose in three main studies involving 2,514 patients with type 2 diabetes. In all studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

· The first study involved 1,663 patients whose diabetes was not adequately controlled with the diabetes medicines metformin or metformin and pioglitazone taken by mouth. Adding Xultophy to their treatment was compared with adding either of its active substances, insulin degludec or liraglutide. The average HbA1c level, which was 8.3% at the start, fell to 6.4% after 26 weeks of treatment with Xultophy, compared with 6.9% and 7.0% respectively with insulin degludec and liraglutide.

· The second study involved 413 patients whose blood glucose was not adequately controlled by insulin and metformin with or without other diabetes medicines taken by mouth. Treatment with Xultophy and metformin was compared with treatment using insulin degludec and metformin. Average HbA1c at the start was 8.7% in the Xultophy group, and fell after 26 weeks of treatment to 6.9%. In the group using insulin degludec it fell from 8.8% to 8.0%.

· The third study involved 438 patients whose blood glucose was not adequately controlled by a combination of a GLP-1 agonist (liraglutide or exenatide) and metformin with or without other diabetes medicines taken by mouth. Patients in the study either continued with their current treatment or received Xultophy instead of the GLP-1 agonist. Average HbA1c was 7.8% before patients started to receive Xultophy, and fell after 26 weeks of treatment to 6.4%. In the group that kept on receiving the GLP-1 agonist, it fell from 7.7% to 7.4%.

The majority of patients treated with Xultophy in these studies achieved control of their blood glucose (HbA1c below 7.0%) and many achieved HbA1c below 6.5%.

What are the risks associated with Xultophy?

The most common side effect with Xultophy (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose). Side effects on the digestive system occurred in up to 1 in 10 patients and included nausea (feeling sick), diarrhoea, vomiting, constipation, dyspepsia (indigestion), gastritis (inflammation of the stomach), abdominal pain (stomach ache), flatulence (wind), gastroesophageal reflux disease (passage of stomach acid back up towards the mouth), and distension (swelling) of the belly. For the full list of side effects and restrictions with Xultophy, see the package leaflet.

Why is Xultophy approved?

The European Medicines Agency decided that Xultophy’s benefits are greater than its risks and it can be authorised for use in the EU. Adding this medicine to other diabetes medicines offers better control of blood glucose and having an alternative treatment option is valuable in individualising treatment.

What measures are being taken to ensure the safe and effective use of Xultophy?

The company that markets Xultophy will provide educational materials for healthcare professionals, explaining how to use the medicine safely, so as to reduce the risk of medication errors.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xultophy have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Xultophy are continuously monitored. Side effects reported with Xultophy are carefully evaluated and any necessary action taken to protect patients.

Other information about Xultophy

Xultophy received a marketing authorisation valid throughout the EU on 18 September 2014.