Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,876
- 主要终点
- Percentage of Participants With Adverse Drug Reactions (ADRs)
研究概览
简要总结
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral antidiabetic drug (OAD)
干预措施: OAD (Drug)
Trazenta
干预措施: Trazenta (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions (ADRs)
时间窗: From start of the treatment until the end of this PMS, i.e. up to week 156
An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied".
次要结局
- Change From Baseline in HbA1c at the Last Observation During the Observation Period.(Baseline and 156 week or last observation)