NCT01685502已完成不适用
Special Drug Use Investigation of Glucobay OD
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
- 2,289
- 主要终点
- Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)
研究概览
简要总结
The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
Patients treated with Glucobay OD under practical manner
干预措施: Glucobay ODT (Acarbose, BAYG5421) (Drug)
结局指标
主要结局
Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)
时间窗: Up to 1 year
Decrease rate of HbA1c
时间窗: Up to 1 year
次要结局
- Body weight(up to1 year)
研究者
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