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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01144338
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Exenatide Once Weekly Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14752 participants
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.
Actual Study Start Date : June 18, 2010
Actual Primary Completion Date : April 21, 2017
Actual Study Completion Date : April 24, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exenatide Once Weekly Drug: Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.
Placebo Comparator: Placebo Drug: Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Efficacy Outcome MACE Events [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]

    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.


  2. Primary Safety Outcome MACE Events [ 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. 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 Outcome Measures :
  1. 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). ]
    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.

  2. Secondary Efficacy Outcome CV Death [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]
    Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.

  3. Secondary Efficacy Outcome MI [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]
    Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.

  4. Secondary Efficacy Outcome Stroke [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ]
    Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.

  5. 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). ]
    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.

  6. 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). ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144338


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Stephanie Gustavson, PhD AstraZeneca
Study Director: Group Director Global Clinical Research Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] December 24, 2009
Statistical Analysis Plan  [PDF] February 23, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01144338    
Other Study ID Numbers: D5551C00003
MB001-002 ( Other Identifier: Bristol Myers Squibb )
BCB109 ( Other Identifier: Bristol-Myers Squibb )
First Posted: June 15, 2010    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018
Last Verified: July 2018
Keywords provided by AstraZeneca:
exenatide once weekly
cardiovascular
Bydureon
Amylin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists