NCT03745157已完成不适用
A Prospective Non-interventional Study Investigating the Treatment Effect of Switching From Insulin Glargine to Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real World Adult Population With Type 2 Diabetes in Japan
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
- 246
- 试验地点
- 1
- 主要终点
- Change in local laboratory measured glycosylated haemoglobin (HbA1c)
研究概览
简要总结
The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol
- •The decision to initiate treatment with commercially available insulin Ryzodeg® 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 more than or equal to 20 years (the legal age of adulthood) at the time of signing informed consent
- •Diagnosed with type 2 diabetes (T2D) for at least 26 weeks prior to signing informed consent
- •Available and documented glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to initiation of Ryzodeg® treatment
- •For at least 26 weeks prior to initiation of Ryzodeg® treatment, one of the following must apply: A) Treated with insulin glargine (IGlar) (any formulation, including biosimilar IGlar). B) Treated with IGlar (any formulation, including biosimilar IGlar) and IGlar U300 for at least 12 weeks prior to initiation of Ryzodeg®
排除标准
- •Previous participation in this study. Participation is defined as signed informed consent.
- •Pregnancy
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Hypersensitivity to Ryzodeg® or to any of the excipients
- •Previously treated with Ryzodeg®
研究组 & 干预措施
Patients with Type 2 Diabetes requiring insulin therapy
Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar)
干预措施: Insulin Degludec/Insulin Aspart (Drug)
结局指标
主要结局
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
时间窗: From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks)
Measured in %point
次要结局
- Change in local laboratory measured fasting plasma glucose (FPG)(From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks))
- The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes(Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks))
- The incidence of patient recollection of overall severe hypoglycaemic episodes(Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks))
- Change in total insulin dose(From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks))
- Change in basal insulin dose(From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks))
- Change in prandial insulin dose(From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks))
- The incidence of patient recollection of non-severe hypoglycaemic episodes(Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks))
- The incidence of patient recollection of nocturnal severe hypoglycaemic episodes(Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks))
- Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)(From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0))
研究者
研究点 (1)
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