NCT01086293已完成不适用
Comparison of Risk of Hospitalization With Acute Liver Failure Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments
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
- 113,505
- 主要终点
- Number of participants hospitalized with a diagnosis of acute liver failure
研究概览
简要总结
The purpose of this study is to compare the incidence of hospitalization with acute liver failure among patients with type 2 diabetes who are new users of Saxagliptin and those who are new users of other oral antidiabetic drugs.
详细描述
Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •18 years of age or older
- •Newly prescribed Saxagliptin or an Oral Antidiabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors
- •Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD
- •Have at least one diagnostic code for a type 2 diabetes-related condition
排除标准
- •Patients identified with a diagnostic code for acute liver failure within the 180-day baseline period
- •Patients with DPP4 inhibitor exposure during the baseline period
结局指标
主要结局
Number of participants hospitalized with a diagnosis of acute liver failure
时间窗: 54-months
次要结局
- Deaths due to acute liver failure(18, 36 and 54 months)
- Hospitalizations with acute liver failure and/or death due to acute liver failure(18, 36 and 54 months)
- Hospitalizations with acute liver injury(18, 36 and 54 months)
研究者
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