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临床试验/NCT01377935
NCT01377935已完成不适用

Comparison of Risk of Hospitalization for Acute Kidney Injury Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

AstraZeneca0 个研究点目标入组 113,505 人开始时间: 2009年8月最近更新:
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
Hospital admission for acute kidney injury

研究概览

简要总结

The purpose of this study is to compare the incidence of hospitalization for acute kidney injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.

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.

This will be a prospectively-designed database cohort study comparing hospitalizations for acute kidney injury among new initiators of Saxagliptin compared to those who are new initiators of OADs in classes other than DPP4 inhibitors. The study time frame will be from 2009 through 2014.

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

入选标准

  • 18 years of age or older
  • Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors
  • Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD

排除标准

  • Patients identified with a diagnostic code for acute kidney injury within the 180-day baseline period
  • Patients with DPP4 inhibitor exposure during the baseline period
  • Patients currently using Exenatide or Insulin

结局指标

主要结局

Hospital admission for acute kidney injury

时间窗: 52 months

次要结局

  • Deaths due to acute kidney injury(54 months)
  • Hospitalizations for acute kidney injury and/or death due to acute kidney injury(54 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

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