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临床试验/NCT02489942
NCT02489942已完成不适用

Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim0 个研究点目标入组 8,145 人开始时间: 2015年6月12日最近更新:
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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
8,145
主要终点
Number of Patients With Adverse Drug Reactions (ADRs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus

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
18 Years 至 —（Adult, Older Adult）
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

研究组 & 干预措施

Jardiance

Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg

干预措施: Jardiance (Drug)

结局指标

主要结局

Number of Patients With Adverse Drug Reactions (ADRs)

时间窗: From first drug administration until 7 days after last drug administration, up to 247 weeks.

Number of patients with adverse drug reactions.

次要结局

  • Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period(At start of treatment and at last observation on treatment, up to 246 weeks.)
  • Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period(At start of treatment and at last observation on treatment, up to 246 weeks.)

研究者

申办方类型
Industry
责任方
Sponsor

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