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 is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01144338

First received: June 10, 2010

Last updated: January 5, 2016

Last verified: January 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2010

Last Updated Date

January 5, 2016

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

April 2018 (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). ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Time to first confirmed cardiovascular event in the primary composite cardiovascular endpoint. [ Time Frame: 5.5 years (average) ] [ Designated as safety issue: No ]

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). ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
Hospitalization for acute coronary syndrome [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ] [ Designated as safety issue: No ]
Hospitalization for heart failure [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Time to all-cause mortality [ Time Frame: 5.5 years (average) ] [ Designated as safety issue: No ]
Time to first confirmed cardiovascular event for each component of the primary composite endpoint [ Time Frame: 5.5 years (average) ] [ Designated as safety issue: No ]
Time to hospitalization for acute coronary syndrome [ Time Frame: 5.5 years (average) ] [ Designated as safety issue: No ]
Time to hospitalization for heart failure [ Time Frame: 5.5 years (average) ] [ Designated as safety issue: No ]

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Active, not recruiting

Estimated Enrollment ^ICMJE

14000

Estimated Completion Date

April 2018

Estimated Primary Completion Date

April 2018 (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.

Gender

Both

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

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, 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

Removed Location Countries

France, India, Peru

Administrative Information

NCT Number ^ICMJE

NCT01144338

Other Study ID Numbers ^ICMJE

D5551C00003, MB001-002, BCB109

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Nardev Khurmi, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2016

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

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