NCT02297620已完成不适用
Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)
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
- 8,687
- 主要终点
- Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors
研究概览
简要总结
The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.
详细描述
Elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used Suglat Tablets within 3 months from its launch are included in this study. Followings are measured with the patients.
- Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors.
- Investigate the occurrence of urinary tract infection.
- Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).
- Investigate the occurrence of adverse drug reactions other than the above.
- Factors that may possibly influence the safety of Suglat Tablets.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes who used Suglat Tablets within 3 months from its launch
排除标准
- •off-label use patients
研究组 & 干预措施
Suglat group
干预措施: Suglat® (Drug)
结局指标
主要结局
Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors
时间窗: Up to 12 months
次要结局
- Investigate the occurrence of urinary tract infection(1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time))
- Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).(1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time))
- Investigate the occurrence of adverse drug reactions other than the above(1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time))
研究者
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