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Completed

NCT Number: NCT01086280

Risk of Cardiovascular Events in Patients With Type 2 Diabetes Initiating Oral Antidiabetic Treatments

The purpose of this study is to compare the incidence of major cardiovascular events among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of oral anti-diabetic drugs (OADs)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

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 for Saxagliptin or other OAD in a class other than DPP4 inhibitors

Exclusion criteria

  • Patients identified with a diagnostic code for any of the cardiovascular outcomes of interest within the 180-day baseline period
  • Patients prescribed a DPP4 inhibitor during the baseline period

Treatment and study plan

Primary outcomes

  1. Major cardiovascular events defined as a composite of acute MI, stroke or death due to acute MI, stroke, CHF, dysrhythmia, sudden death, or coronary revascularization. Alternative outcomes include DVT, PE, and arterial vascular disease

    Time frame: 18-months

    Myocardial infarction (MI), congestive heart failure (CHF), deep venous thrombosis (DVT), pulmonary embolism (PE)

  2. Major cardiovascular events defined as a composite of acute MI, stroke or death due to acute MI, stroke, CHF, dysrhythmia, sudden death, or coronary revascularization. Alternative outcomes include DVT, PE, and arterial vascular disease

    Time frame: 36-months

  3. Major cardiovascular events defined as a composite of acute MI, stroke or death due to acute MI, stroke, CHF, dysrhythmia, sudden death, or coronary revascularization. Alternative outcomes include DVT, PE, and arterial vascular disease

    Time frame: 54-months

Secondary outcomes

  1. Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined

    Time frame: 18-months

  2. Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined

    Time frame: 36-months

  3. Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined

    Time frame: 54-months

  4. All-cause death

    Time frame: 18-months

  5. All-cause death

    Time frame: 36-months

  6. All-cause death

    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 Major Cardiovascular Events 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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