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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Comparison of Risk of Major Cardiovascular Events Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients exposed to Saxagliptin<br> | |
| Patients exposed to oral antidiabetic drugs (not Saxagliptin)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Myocardial infarction (MI), congestive heart failure (CHF), deep venous thrombosis (DVT), pulmonary embolism (PE) | 18-months | 
| 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 |  | 36-months | 
| 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 |  | 54-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined |  | 18-months | 
| Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined |  | 36-months | 
| Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined |  | 54-months | 
| All-cause death |  | 18-months | 
| All-cause death |  | 36-months | 
| All-cause death |  | 54-months |