NCT02754817已完成不适用
A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
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
- 611
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Hemoglobin A1c)
研究概览
简要总结
This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 extraction of data according to the protocol)
- •Male or female patients at least 18 years of age at time of informed consent
- •Diagnosis of T2DM (type 2 diabetes mellitus)
- •Xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). Patients may or may not be continuing Xultophy® at study inclusion
- •Minimum available data:a.) At the time of Xultophy® prescription: HbA1c value (or if unavailable, the most recent HbA1c value within 6 months before the first Xultophy® prescription);b.) At 6 months plus/minus 45 days after first Xultophy® prescription: HbA1c value
排除标准
- •Type 1 diabetes
- •Previous participation in this study. Participation is defined as having provided informed consent
- •Participation in a clinical trial within 6 months before or 12 months after the first Xultophy® prescription (Participation in a non-interventional study is not an exclusion criteria)
- •Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation
研究组 & 干预措施
Insulin degludec/liraglutide
干预措施: insulin degludec/liraglutide (Drug)
结局指标
主要结局
Change in HbA1c (Hemoglobin A1c)
时间窗: week 0, week 26
次要结局
- Change in HbA1c(Month 0, month 3, month 9, months 12)
- Percentage of responders for HbA1c below 7 percent (53 mmol/mol)(At 3, 6, 9 and 12 months)
- Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain(At 3, 6, 9 and 12 months)
- Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes(At 3, 6, 9 and 12 months)
研究者
研究点 (1)
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