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

NCTNCT01144338Other idD5551C00003Other idMB001-002Other idBCB109

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 14,752 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Triple masking
Countries: 30 countries
United States, 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
Start: 18 Jun 2010
Primary completion: 21 Apr 2017
Completion: 24 Apr 2017
First posted: 15 Jun 2010 (estimated)
Last update posted: 8 Aug 2018
Conditions: Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20102012201420162018

Ph 3
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
18 Jun 2010 to 24 Apr 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Exenatide Once WeeklyDrug
PlaceboDrug

Arms2

Experimental
Exenatide Once Weekly
Placebo comparator
Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

Primary Efficacy Outcome MACE Events
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
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.
Primary Safety Outcome MACE Events
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
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.

Secondary outcomes(6)

Secondary Efficacy Outcome All-Cause Mortality
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
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.
Secondary Efficacy Outcome CV Death
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.
Secondary Efficacy Outcome MI
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.
Secondary Efficacy Outcome Stroke
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.
Secondary Efficacy Outcome Hospitalization for ACS
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
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.
Secondary Efficacy Outcome Hospitalization for HF
Time frame · Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Primary Efficacy Outcome MACE Events

Group	Value (Participants)
Placebo	905
Exenatide Once Weekly	839

Primary outcomeCount of participants· Time to first event. Information collected during study period (anticipated to be up to 7.5 years).