Open, Prospective, Multicentric, Single-arm, Non-interventional Study to Evaluate the Effectiveness & Safety of Oral Glucobay®-M Tablets in Type 2 Diabetes Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 9,364
- 主要终点
- Change in fasting blood glucose levels
研究概览
简要总结
An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M under daily life treatment of type-2 diabetes patients.The study objectives are to investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus, where investigator feels that addition of Glucobay®-M would be beneficial to patients will be included in non- interventional study. The routine investigation suggested by the attending physician will be done in diabetic patients. No additional investigation will be done for the study purpose. The uncontrolled diabetic patient on existing treatment and prescribed Glucobay®-M will be included in study after taking the informed consent. The patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one tablet will be included in the safety analysis.The study is planned to be carried out in 10000 patients from 320-350 trial sites in India.
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
- •Female and male patients ≥ 18 years of age with Type 2 Diabetes where investigator feels that addition of Glucobay®-M would be beneficial to patients.
- •The diagnosis will be made based on the ADA criteria by the attending physician.
- •Patients will be defined as included in the study if they have a documented prescription of Glucobay-M by the physician.
- •Patients willing to provide signed & dated informed consent.
- •Patients willing to comply with study requirements.
排除标准
- •According to the local product information
研究组 & 干预措施
Group 1
干预措施: Glucobay M (Acarbose/Metformin, BAY81-9783) (Drug)
结局指标
主要结局
Change in fasting blood glucose levels
时间窗: 12 weeks
Change in post-prandial glucose values
时间窗: 12 weeks
Change in Hemoglobin A1c (HbA1c) levels
时间窗: 12 weeks
次要结局
- Number of patient with adverse events(12 weeks)
- Percentage of patients with satisfaction of treatment(12 weeks)