A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 597
- 试验地点
- 1
- 主要终点
- Change in glycated haemoglobin (HbA1c) (percentage)
研究概览
简要总结
The purpose of the study is to collect information on how Tresiba® works in real world patients. Patients will get Tresiba® as prescribed to them by their study doctor. The study will last for about 6 to 8 months. Patients will be asked questions about their health and 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 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 Tresiba® 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 above or equal to 18 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes and treated with any antihyperglycaemic medication(s), except Tresiba®, for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1)
- •Available and documented HbA1c value measured within the last 12 weeks prior to initiation of Tresiba® treatment
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Hypersensitivity to the active substance or to any of the excipients as specified in the Tresiba® local label
研究组 & 干预措施
Tresiba®
Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks.
干预措施: Insulin degludec (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c) (percentage)
时间窗: Week 0 (baseline), Week 26 (end of study)
Measured in percentage. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
Change in HbA1c (mmol/mol)
时间窗: Week 0 (baseline), Week 26 (end of study)
Measured in mmol/mol. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
次要结局
- Change in fasting plasma glucose (FPG) (mg/dL)(Week 0 (baseline), Week 26 (end of study))
- Change in daily insulin doses: Basal insulin(Week 0 (baseline), Week 26 (end of study))
- Change in daily insulin doses: Prandial insulin(Week 0 (baseline), Week 26 (end of study))
- Change in daily insulin doses: Total insulin(Week 0 (baseline), Week 26 (end of study))
- Change in number of patient reported overall non-severe hypoglycaemic episodes(Week -4 to 0, week 22 to 26)
- Change in number of patient reported nocturnal non-severe hypoglycaemic episodes(Week -4 to 0, week 22 to 26)
- Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable(Week 26)
- Change in FPG (mmol/L)(Week 0 (baseline), Week 26 (end of study))
- Change in number of patient reported severe hypoglycaemic episodes (overall)(Week -26 to 0, week 0 to 26)