NCT02284269Unknown不适用
Meta-analysis in Post-Marketing Surveillances for Long-Term Drug Use of SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Pharmaceuticals and Medical Devices Agency, Japan0 个研究点目标入组 18,000 人开始时间: 2014年10月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18,000
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions.
In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse events
时间窗: up to 3 years
次要结局
- Incidence of cardiovascular events(up to 3 years)
- The change from baseline in vital signs and laboratory data(Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration)
- Incidence of cancer(up to 3 years)
- Incidence of other adverse events(up to 3 years)
- Incidence of drug-related adverse events(up to 3 years)
- Incidence of serious adverse events(up to 3 years)
- The change from baseline in HbA1c(Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration)
- The change from baseline in Fasting Plasma Glucose(Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration)
研究者
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