This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
14,752
Subcutaneous injection, 2 mg, administered once weekly.
Subcutaneous injection, matching volume of placebo, administered once weekly.
Primary Efficacy Outcome MACE Events
The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Primary Safety Outcome MACE Events
The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome All-Cause Mortality
The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome CV Death
Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome MI
Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.
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Research Site
Birmingham, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Jonesboro, Arkansas, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Chula Vista, California, United States
Research Site
Concord, California, United States
Research Site
Escondido, California, United States
Research Site
Fullerton, California, United States
Research Site
Greenbrae, California, United States
...and 619 more locations
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Stroke
Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Hospitalization for ACS
The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Hospitalization for HF
The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.
Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).