NCT02662114已完成不适用
A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,302
- 试验地点
- 1
- 主要终点
- Change in HbA1c after switch to Tresiba®
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus.
EU-TREAT (EUropean TREsiba AudiT)
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
- •Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient
- •Age at least 18 years at the time of Tresiba® initiation
- •T1DM or insulin-treated T2DM patients
- •Switched to Tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with Tresiba® at the time of patient selection
- •Previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to Tresiba®
- •At least one documented medical visit in the first 9 months after Tresiba® initiation
- •Minimum available data at the time of Tresiba® initiation: age, type of diabetes, HbA1c (Glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an eGFR (Estimated glomerular filtration rate )value in the last 12 months
排除标准
- •Previous participation in this study. Participation is defined as having signed the Informed Consent
- •Participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of Tresiba®
- •Current participation in another non-interventional study on insulin degludec (Tresiba®)
- •Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba®
结局指标
主要结局
Change in HbA1c after switch to Tresiba®
时间窗: Month 0, Month 6
次要结局
- Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®(0 to +12 months)
- Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba®(Month 0, Month 12)
- Change in the mean FPG level after switch to Tresiba®(Month 0, Month 12)
- Tresiba® starting dose at switch and doses(At 12 months)
- Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®(Month 0, Month 12)
- Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba®(Month 0, Month 6)
- Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®(0 to +12 months)
- Change in HbA1c after switch to Tresiba®(Month 0, Month 12)
- Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®(0 to +12 months)
- Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba®(-6 to 0 months (ie 6 months before switch to Tresiba®))
- Reason(s) for discontinuing Tresiba®, if applicable and available(Month 0, Month 12)
- Percentage of patients continuing Tresiba® post-switch(At 12 months)
- Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®(Month 0, Month 12)
- Change in body weight (kg) after switch to Tresiba®(Month 0, Month 12)
- Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)(0 to +12 months)
- Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba®(-6 to 0 months ie 6 months before switch to Tresiba®)
- Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®(0 to +12 months)
- Reason(s) for starting Tresiba®, if available(Month 0, Month 12)
- Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®(Month 0, Month 12)
研究者
研究点 (1)
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