NCT03823339已完成不适用
A Multicenter Prospective Non-interventional Study Investigating the Treatment Effect of Xultophy® Intensification in a Real World Population With Type 2 Diabetes in United Arab Emirates
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
- 300
- 试验地点
- 1
- 主要终点
- Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of the study is to collect information on how Xultophy® works in patients with type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26-34 weeks. The participants will be asked questions about their health and their diabetes treatment as part of their 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
- •Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- •The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study.
- •Male or female, age greater than or equal to 18 years at the time of signing informed consent.
- •Diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral anti-diabetic drugs (OADs) or Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) plus or minus OADs, except Xultophy®, for at least 12 weeks prior to informed consent and initiation visit (visit 1).
- •Available and documented glycosylated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of Xultophy® treatment.
排除标准
- •Hypersensitivity to the active substance or to any of the excipients as specified in the Xultophy® local label.
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Female who is known pregnant, breast-feeding or intends to become pregnant.
- •Treated with Xultophy® previously.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Patients with type 2 diabetes (T2DM)
Patients with T2DM treated with any basal insulin or glucagon-Like peptide-1 receptor agonist (GLP-1 RA) (including once weekly GLP-1 RA) with/without oral antidiabetic drug (OAD) treatment, and with inadequate glycaemic control, for whom the physician had decided to intensify their treatment with Xultophy®
干预措施: Insulin degludec/liraglutide (Drug)
结局指标
主要结局
Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)
时间窗: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
Measured in % point
次要结局
- Patients reached HbA1c less than 7% at end of study (Yes/No )(At the end of study visit (26-34 weeks))
- Change in laboratory measured fasting plasma glucose (FPG)(From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks))
- Average dose step of Xultophy® at end of the study(At the end of study (26-34 weeks))
- Change of body weight(From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks))
- Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection(Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks))
- Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection(Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks))
- Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall)(Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks))
- Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable(At the end of study (26-34 weeks))
研究者
研究点 (1)
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