NCT02479399已完成不适用
Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)
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
- 11,412
- 主要终点
- Incidence of cardiovascular adverse events
研究概览
简要总结
The objective of this survey is to confirm the safety of Suglat Tablets
详细描述
The objective of this survey is to confirm the safety and efficacy of Suglat Tablets for long-term use over 3 years.
Specify the effects of Suglat Tablets on the cardiovascular system, incidence rates of malignant tumor, and their risk factors.
Investigate the occurrence of adverse drug reactions. Specify factors that may possibly influence the safety and efficacy of Suglat Tablets.
<Items of interest>
- Hypoglycemia
- Genital infection
- Urinary tract infection
- Polyuria and pollakiuria
- Adverse events related to a decrease in body fluids (dehydration, etc.)
- Malignant tumor
- Cardiovascular diseases
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015
排除标准
- •off-label use patients
研究组 & 干预措施
Suglat group
Tablets
干预措施: ipragliflozin (Drug)
结局指标
主要结局
Incidence of cardiovascular adverse events
时间窗: Up to 3 years
Incidence of malignant tumor
时间窗: Up to 3 years
次要结局
- Safety developed by adverse events and laboratory tests(Up to 3 years)
研究者
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