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临床试验/NCT01219582
NCT01219582已完成不适用

Open, Prospective, Multicentric, Single-arm, Non-interventional Study to Evaluate the Effectiveness & Safety of Oral Glucobay®-M Tablets in Type 2 Diabetes Patient

Bayer0 个研究点目标入组 9,364 人开始时间: 2010年10月最近更新:
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
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

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)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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