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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

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