Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.
Enrollment: 14752
Actual Study Start Date: June 18, 2010
Study Completion Date: April 24, 2017
Primary Completion Date: April 21, 2017 (Final data collection date for primary outcome measure)
Arms:
- Experimental: Exenatide Once Weekly
- Placebo Comparator: Placebo
Category | Value |
---|---|
Date last updated at source | 2017-08-31 |
Study type(s) | Interventional |
Expected enrolment | 14752 |
Study start date | 2010-06-18 |
Estimated primary completion date | 2017-04-01 |