The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications
A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18,206
5 mg or 2.5 mg once daily
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Time frame: Randomization (day 0) up to 2.9 years
Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation
Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Time frame: Randomization (day 0) up to 2.9 years
Participants With Event of Death
Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.
Time frame: Randomization (day 0) up to 2.9 years
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tempe, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Alhambra, California, United States
Research Site
Anaheim, California, United States
Research Site
Bakersfield, California, United States
Research Site
Burlingame, California, United States
Research Site
Duarte, California, United States
...and 526 more locations