Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Detailed 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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
University of Pennsylvania
AstraZeneca
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital admission for acute kidney injury | 52 months |
Secondary
| Measure | Time frame |
|---|---|
| Deaths due to acute kidney injury | 18 months |
| Hospitalizations for acute kidney injury and/or death due to acute kidney injury | 18 months |
Outcome results
None listed