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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

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
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Exenatide Once Weekly
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 14000
Study Start Date: June 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144338

Contacts
Contact: PAREXEL EXSCEL Inquiries EXSCELenquiries@PAREXEL.com

  Show 764 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Group Director Global Clinical Research Bristol-Myers Squibb
  More Information

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01144338     History of Changes
Other Study ID Numbers: BCB109, MB001-002
Study First Received: June 10, 2010
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
exenatide once weekly
cardiovascular
Bydureon
Amylin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014