Risk of Acute Kidney Injury Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

AstraZeneca

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01377935

CV181-157

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 113,505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

113,505 participants in 2 patient groups

Patients exposed to Saxagliptin

Patients exposed to OAD in classes other than DPP4 inhibitors

Description:

OAD - Oral Antidiabetic Drug