Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

AstraZeneca113,505 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

113,505

Conditions

Diabetes Mellitus, Type 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants hospitalized with a diagnosis of acute liver failure

Time frame: 18-months

Number of participants hospitalized with a diagnosis of acute liver failure

Time frame: 36-months

Number of participants hospitalized with a diagnosis of acute liver failure

Time frame: 54-months

Secondary Outcomes

Deaths due to acute liver failure

Time frame: 18, 36 and 54 months

Hospitalizations with acute liver failure and/or death due to acute liver failure

Time frame: 18, 36 and 54 months

Hospitalizations with acute liver injury

Time frame: 18, 36 and 54 months

Data from ClinicalTrials.gov

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