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临床试验/NCT03761797
NCT03761797已完成不适用

Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 1,164 人开始时间: 2019年1月15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
1,164
试验地点
1
主要终点
Number of Participants 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研究点记录与标识符相似试验

研究概览

简要总结

Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP
  • •Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment

排除标准

  • 未提供

研究组 & 干预措施

Subjects with type 2 Diabetes Mellitus

干预措施: TRADIANCE® Combination Tablets AP (Drug)

Subjects with type 2 Diabetes Mellitus

干预措施: TRADIANCE® Combination Tablets BP (Drug)

结局指标

主要结局

Number of Participants With Adverse Drug Reactions (ADRs)

时间窗: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.

The number of participants with adverse drug reactions is reported.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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