NCT04227431已完成不适用
The Effect of Tresiba® (Insulin Degludec) in Type 2 Diabetes Patients in Real World Clinical Practice in China - Noninterventional, Retrospective Chart Review Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 938
- 试验地点
- 56
- 主要终点
- Change in glycosylated haemoglobin (HbA1c)
研究概览
简要总结
The purpose of the study is to collect information on how Tresiba® works in patients with type 2 diabetes in China. The study will be based on data already recorded in participants' medical records and no new tests or procedures are required as part of the study. This study does not affect participants' current diabetes treatment. The study will look at data recorded in participants' medical records for approximately the last year. After signing the informed consent form, no further activities will be required from the participants.
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 Form (ICF) obtained before any study-related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female, aged at least 18 years at the time of signing the ICF.
- •Diagnosed with T2D.
- •Treated with any OAD(s) or basal insulin ± OAD(s), with or without prandial insulin for at least 20 weeks prior to treatment initiation with Tresiba®.
- •The decision to initiate treatment with commercially available Tresiba® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
- •Treated with Tresiba® (with or without OADs, with or without prandial insulin) for at least 20 weeks and have at least one documented medical visit with HbA1c measurement in the first 20 weeks (plus/minus 8 weeks) after Tresiba® initiation. The patient may or may not be treated with Tresiba® at the time of patient selection to this study.
- •Minimum available data: age, weight, and sex at the time of Tresiba® initiation, HbA1c (most recent value within 12 weeks prior to Tresiba® initiation and a value in the first 20 weeks [plus/minus 8 weeks] after Tresiba® treatment), and duration and type of insulin treatment (for insulin treated patients).
排除标准
- •Previous participation in this study. Participation is defined as having signed the ICF.
- •Participation (defined as randomisation) in a diabetes clinical trial of an approved or non-approved investigational medicinal product within 20 weeks prior to the treatment initiation with Tresiba® or during the first 28 weeks of treatment with Tresiba®.
- •Tresiba® not used in accordance with the local label.
- •Patients treated with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® (short-term [equal to or less than 14 days] treatment with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® is allowed).
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
结局指标
主要结局
Change in glycosylated haemoglobin (HbA1c)
时间窗: Week 0, week 20
Percent point
次要结局
- Change in self-measured fasting plasma glucose (SMPG)(From baseline (week 0) to end of study (week 20))
- Change in daily insulin doses (total, basal, prandial)(From baseline (week 0) to end of study (week 20))
- Change in number of concomitant non-insulin anti-diabetic drugs before and after add-on/switch to Tresiba®(From baseline (week 0) to end of study (week 20))
- Change in laboratory-measured fasting plasma glucose (FPG)(From baseline (week 0) to end of study (week 20))
- Change in rates of hypoglycaemic episodes (number of episodes/patient years) (overall, nonsevere, severe, nocturnal) before and after add on of/switch to Tresiba®(From baseline (week 0) to end of study (week 20))
- Patient having at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after add-on of/switch to Tresiba® (Yes/no)(From baseline (week 0) to end of study (week 20))
- Reason(s) for starting Tresiba®, at time of switch/add-on, if available(At baseline (week 20))
研究者
研究点 (56)
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