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

NCT01144338 · Completed

Last updated 2026-05-28

This clinical trial tested whether once-weekly injections of exenatide, a diabetes medication, could reduce heart-related events in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 14,752 people

Who can join Ages 18–130 · all sexes

Timeline Started 2010-06 · est. completion 2017-04

Where 629 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT01144338 ↗

Description as written by the study sponsor.

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.

Treatments tested

Exenatide Once Weekly Drug

Subcutaneous injection, 2 mg, administered once weekly.
Placebo Drug

Subcutaneous injection, matching volume of placebo, administered once weekly.

Main thing measured	Primary Efficacy Outcome MACE Events
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01144338 ↗