NCT02090673已完成不适用
Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea
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
- AstraZeneca
- 入组人数
- 1,711
- 试验地点
- 1
- 主要终点
- The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus
研究概览
简要总结
The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female at least 18 years of age
- •Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
- •Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information
排除标准
- •Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
- •Are pregnant or have intentions of becoming pregnant within the duration of the study
- •Contraindications
研究组 & 干预措施
Group1:Type 2 diabetic patients treated with Exenatide therapy
Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label
干预措施: Exenatide (Drug)
结局指标
主要结局
The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus
时间窗: At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks
次要结局
- Change from baseline to endpoint in Hemoglobin A1c (HbA1c)(Baseline (Day 1) and 12 or 24 weeks ± 4 weeks)
- Change from baseline to endpoint in Body weight(Baseline (Day 1) and 12 or 24 weeks ± 4 weeks)
- Change from baseline to endpoint in Fasting plasma glucose(Baseline (Day 1) and 12 or 24 weeks ± 4 weeks)
- Change from baseline to endpoint in subjective measures include improvement of main indication(Baseline (Day 1) and 12 or 24 weeks ± 4 weeks)
研究者
研究点 (1)
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