Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT01086293
- Lead Sponsor
- AstraZeneca
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113505
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants hospitalized with a diagnosis of acute liver failure 54-months
- Secondary Outcome Measures
Name Time Method 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