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 currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01144338
First received: June 10, 2010
Last updated: October 9, 2014
Last verified: October 2014

June 10, 2010
October 9, 2014
June 2010
December 2017   (final data collection date for primary outcome measure)
  • 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 ]
Time to first confirmed cardiovascular event in the primary composite cardiovascular endpoint. [ Time Frame: 5.5 years (average) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01144338 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Exenatide Once Weekly
    Subcutaneous injection, 2 mg, administered once weekly.
  • Drug: Placebo
    Subcutaneous injection, matching volume of placebo, administered once weekly.
  • Experimental: Exenatide Once Weekly
    Intervention: Drug: Exenatide Once Weekly
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Gaebler JA, Soto-Campos G, Alperin P, Cohen M, Blickensderfer A, Wintle M, Maggs D, Hoogwerf B, Han J, Pencek R, Peskin B. Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: a simulation analysis. Vasc Health Risk Manag. 2012;8:255-64. doi: 10.2147/VHRM.S28744. Epub 2012 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14000
April 2018
December 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: PAREXEL EXSCEL Inquiries EXSCELenquiries@PAREXEL.com
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
 
NCT01144338
BCB109, MB001-002
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Group Director Global Clinical Research Bristol-Myers Squibb
Bristol-Myers Squibb
October 2014

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