NCT04656106已完成不适用
A Retrospective Multi-centre Non-interventional Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea
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
- 200
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Hemoglobin)
研究概览
简要总结
This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation
- •Type 2 diabetes mellitus patients
- •Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®
- •Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)
- •At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation
- •Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c [Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation]
- •The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study.
排除标准
- •Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®
- •Patients switching to Ryzodeg® below 26 weeks prior to the data collection date
- •Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®
- •Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®
- •Pregnancy patient
- •Patients not treated with the local licensed Ryzodeg®
研究组 & 干预措施
Ryzodeg
Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.
干预措施: Ryzodeg® (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Hemoglobin)
时间窗: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Percentage point
次要结局
- Change in FPG (Fasting Plasma Glucose)(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
- Change in daily total insulin dose(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
- Change in daily basal insulin dose(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
- Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®(Period 1(week-26 to week 0), Period 2(week 0 to week 26))
- Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®(Period 1(week-26 to week 0), Period 2(week 0 to week 26))
- Patients with HbA1c less than 7.0 percentage (Yes or No)(End of study (week 26))
- Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)(End of study (week 26))
- Change in daily prandial insulin dose(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
- Change in body weight(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)Renal Cell CarcinomaNCT05012865Pfizer48
已完成
不适用
JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment StudyUrothelial CarcinomaNCT06412848Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany360
已完成
不适用
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)Renal Cell CarcinomaNCT05650164Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany171
已完成
不适用
Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell CarcinomaCarcinoma, Renal CellNCT01982097Bayer61
已完成
不适用
A Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast CancerHER2-positive Breast CancerNCT05769751Daiichi Sankyo865