Risk of Cardiovascular Events in Patients With Type 2 Diabetes Initiating Oral Antidiabetic Treatments
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT01086280
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113505
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined 54-months All-cause death 54-months