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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

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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

Tracking Information
First Submitted Date  ICMJE June 10, 2010
First Posted Date  ICMJE June 15, 2010
Results First Submitted Date  ICMJE April 13, 2018
Results First Posted Date  ICMJE August 8, 2018
Last Update Posted Date August 8, 2018
Actual Study Start Date  ICMJE June 18, 2010
Actual Primary Completion Date April 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2010)		 Time to first confirmed cardiovascular event in the primary composite cardiovascular endpoint. [ Time Frame: 5.5 years (average) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
  • 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: August 31, 2017)		 14752
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2010)		 9500
Actual Study Completion Date  ICMJE April 24, 2017
Actual 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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  ICMJE 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 July 2018

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