Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
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
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 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants hospitalized with a diagnosis of acute liver failure | 18-months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed