NCT04315688已完成不适用
A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia
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
- 494
- 试验地点
- 1
- 主要终点
- Change in laboratory measured HbA1c (mmol/mol)
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 with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal 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 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 antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1).
- •Available and documented HbA1c value 12 weeks or less 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
干预措施: insulin degludec (Drug)
结局指标
主要结局
Change in laboratory measured HbA1c (mmol/mol)
时间窗: From baseline (week -12 to 0) to end of study (week 26-36)
mmol/mol
Change in laboratory measured glycated haemoglobin (HbA1c) (% point)
时间窗: From baseline (week -12 to 0) to end of study (week 26-36)
% point
次要结局
- Change in laboratory measured fasting plasma glucose (FPG)(From baseline (week -12 to 0) to end of study (week 26-36))
- Change in daily insulin doses (basal insulin)(From baseline (week -12 to 0) to end of study (week 26-36))
- Change in number of patient reported severe hypoglycaemic episodes (overall)(Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36))
- Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options)(After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36))
- Change in laboratory measured FPG(From baseline (week -12 to 0) to end of study (week 26-36))
- Change in daily insulin doses (prandial insulin)(From baseline (week -12 to 0) to end of study (week 26-36))
- Change in number of patient reported overall non-severe hypoglycaemic episodes(Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36))
- Change in number of patient reported nocturnal non-severe hypoglycaemic episodes(Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36))
- Change in daily insulin doses (total insulin)(From baseline (week -12 to 0) to end of study (week 26-36))
研究者
研究点 (1)
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