Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Metformin Under Daily Life Treatment Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 19,509
- 主要终点
- Data collection on pre treatment concomitant diseases
研究概览
简要总结
In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of metformin under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.
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
- •All patient with type 2 diabetes with one of the following treatment ongoing : 1) Metformin 2) Metformin + OHA.
- •In such patients, if investigator feels that addition of acarbose would be benficial for the patients
排除标准
- •According to local product information
研究组 & 干预措施
Group 1
干预措施: Acarbose (Precose/Glucobay, BAYG5421) (Drug)
结局指标
主要结局
Data collection on pre treatment concomitant diseases
时间窗: 16 weeks
Data collection on blood glucose
时间窗: 16 weeks
Data collection on Hba1c
时间窗: 16 weeks
Data collection on body weight
时间窗: 16 weeks
次要结局
- Safety variables will be summarized using descriptive statistics based on adverse events collection(16 weeks)