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Completed

NCT Number: NCT01086293

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants hospitalized with a diagnosis of acute liver failure

    Time frame: 18-months

  2. Number of participants hospitalized with a diagnosis of acute liver failure

    Time frame: 36-months

  3. Number of participants hospitalized with a diagnosis of acute liver failure

    Time frame: 54-months

Secondary outcomes

  1. Deaths due to acute liver failure

    Time frame: 18, 36 and 54 months

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

    Time frame: 18, 36 and 54 months

  3. Hospitalizations with acute liver injury

    Time frame: 18, 36 and 54 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb
  • University of Pennsylvania

Registry information

Official study title

Comparison of Risk of Hospitalization With Acute Liver Failure Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2010
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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