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 has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01144338

First received: June 10, 2010

Last updated: May 31, 2017

Last verified: May 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2010

Last Updated Date

May 31, 2017

Actual Start Date ^ICMJE

June 18, 2010

Primary Completion Date

April 21, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]
The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]

Original Primary Outcome Measures ^ICMJE

Time to first confirmed cardiovascular event in the primary composite cardiovascular endpoint. [ Time Frame: 5.5 years (average) ]

Change History

Complete list of historical versions of study NCT01144338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

All-cause mortality [ Time Frame: Time to event. Information collected during study period (anticipated to be up to 7.5 years). ]
Components of the primary composite endpoint (cardiovascular death, fatal or nonfatal MI, fatal or nonfatal stroke). [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]
Hospitalization for acute coronary syndrome [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]
Hospitalization for heart failure [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]

Original Secondary Outcome Measures ^ICMJE

Time to all-cause mortality [ Time Frame: 5.5 years (average) ]
Time to first confirmed cardiovascular event for each component of the primary composite endpoint [ Time Frame: 5.5 years (average) ]
Time to hospitalization for acute coronary syndrome [ Time Frame: 5.5 years (average) ]
Time to hospitalization for heart failure [ Time Frame: 5.5 years (average) ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.
Drug: Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.

Study Arms

Experimental: Exenatide Once Weekly
Intervention: Drug: Exenatide Once Weekly
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

14780

Completion Date

April 24, 2017

Primary Completion Date

April 21, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient has type 2 diabetes mellitus
Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

Exclusion Criteria:

Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
Patient has a planned or anticipated revascularization procedure.
Pregnancy or planned pregnancy during the trial period.
Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m2.
Patient has a history of gastroparesis or pancreatitis.
Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 130 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

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

Removed Location Countries

Czech Republic, France, India, Peru

Administrative Information

NCT Number ^ICMJE

NCT01144338

Other Study ID Numbers ^ICMJE

D5551C00003
MB001-002 ( Other Identifier: Bristol Myers Squibb )
BCB109 ( Other Identifier: Bristol-Myers Squibb )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Stephanie Gustavson, PhD	AstraZeneca
Study Director:	Group Director Global Clinical Research	Bristol-Myers Squibb

PRS Account

AstraZeneca

Verification Date

May 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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