NCT04666987已完成不适用
A Prospective, Non-interventional, Single Arm Study Investigating Long-term Glycaemic Control in Patients With Type 2 Diabetes Initiating Xultophy® (IDegLira) in a Realworld Setting in Italy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 28
- 主要终点
- Change in Glycated Haemoglobin (HbA1c)
研究概览
简要总结
The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. Participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities (study-related activities include any procedure related to recording of data according to the protocol).
- •Male or female, age greater than or equal to 18 years at the time of signing informed consent.
- •Patient diagnosed with T2D greater than or equal to 12 months prior to signing informed consent.
- •The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.
- •Treated with basal insulin with or without use of oral antidiabetics (OADs), with or without use of bolus insulin prior to initiating Xultophy®.
- •For patients transferring from a regimen including bolus insulin, upon initiation of Xultophy® the bolus insulin component of the treatment regimen was stopped.
- •The patient initiated Xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent.
- •Available and documented HbA1c measurement no more than 3 months prior to Xultophy® initiation.
排除标准
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than T2D.
- •Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study.
- •Any contraindications for Xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the Xultophy® local label.
研究组 & 干预措施
Xultophy®
Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy
干预措施: Insulin degludec and liraglutide (IDegLira) (Drug)
结局指标
主要结局
Change in Glycated Haemoglobin (HbA1c)
时间窗: From baseline (V0, month 0) to 6 months after initiation.
Percent (%) point Baseline is defined as the time of Xultophy® initiation (V0); if the endpoint variable is unavailable at (V0), the most recent value within 3 months prior to Xultophy® initiation will be used. (This definition of baseline applies to all outcome measures.)
次要结局
- Reason for switching to Xultophy® (precoded question list)(At baseline (V0, month 0))
- HbA1c levels less than 7% (yes/no)(At end of study (V3, 18 ±3 months))
- Number of self-reported nocturnal nonsevere hypoglycaemic episodes (defined based on the patient's perception of whether or not it was night) based on recollection(Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit)
- Change in Xultophy® daily dose(From baseline (V0, month 0) to end of study (V3, 18 ±3 months))
- Change in HbA1c(From baseline (V0, month 0) to end of study (V3, 18 ±3 months))
- HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)(At end of study (V3, 18 ±3 months))
- Number of self-reported non-severe hypoglycaemia episodes (defined as an episode with symptoms and/or self monitored blood glucose (SMBG) value less than or equal to 3.9 mmol/L) based on recollection(Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit)
- Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)(At end of study (V3, 18 ±3 months))
- Number of self-reported severe hypoglycaemic episodes (Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action) based on recollection(Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit)
- Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no)(At end of study (V3, 18 ±3 months))
研究者
研究点 (28)
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