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Completed

NCT Number: NCT01377935

Risk of Acute Kidney Injury Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

The purpose of this study is to compare the incidence of hospitalization for acute kidney injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.

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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.

This will be a prospectively-designed database cohort study comparing hospitalizations for acute kidney injury among new initiators of Saxagliptin compared to those who are new initiators of OADs in classes other than DPP4 inhibitors. The study time frame will be from 2009 through 2014.

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 OAD in a class other than DPP4 inhibitors
  • Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD

Exclusion criteria

  • Patients identified with a diagnostic code for acute kidney injury within the 180-day baseline period
  • Patients with DPP4 inhibitor exposure during the baseline period
  • Patients currently using Exenatide or Insulin

Treatment and study plan

Primary outcomes

  1. Hospital admission for acute kidney injury

    Time frame: 52 months

Secondary outcomes

  1. Deaths due to acute kidney injury

    Time frame: 18 months

  2. Deaths due to acute kidney injury

    Time frame: 36 months

  3. Deaths due to acute kidney injury

    Time frame: 54 months

  4. Hospitalizations for acute kidney injury and/or death due to acute kidney injury

    Time frame: 18 months

  5. Hospitalizations for acute kidney injury and/or death due to acute kidney injury

    Time frame: 36 months

  6. Hospitalizations for acute kidney injury and/or death due to acute kidney injury

    Time frame: 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 for Acute Kidney Injury Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jun 22, 2011
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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