NCT00622323已完成不适用
Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide
研究概览
简要总结
This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.
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
- •are male or female outpatients at least 18 years of age
- •provide written consent to the release of their data after being informed of the study
- •diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both
- •are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care
- •are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient
排除标准
- •are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
- •are currently taking insulin.
- •are pregnant or have intentions of becoming pregnant within the duration of the study.
- •are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.
结局指标
主要结局
To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide
时间窗: 12 weeks
次要结局
- To evaluate the change from baseline to endpoint in HbA1c and body weight of Filipino patients with type 2 diabetes mellitus treated with exenatide who are taking metformin and/or a sulfonylurea but have not achieved adequate glycemic control.(12 weeks)
研究者
研究点 (1)
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