Text Size

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.
Verified May 2012 by Amylin Pharmaceuticals, LLC.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01144338
First received: June 10, 2010
Last updated: February 7, 2013
Last verified: May 2012
History of Changes
  Purpose

This study will compare the impact of including exenatide once weekly as part of usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary cardiovascular combined 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 3

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:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 9500
Study Start Date: June 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 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 taken insulin within 2 weeks of screening visit or for greater than 1 week within 3 months of screening visit.
  • Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
  • 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 previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144338

Contacts
Contact: Amylin Call Center 800-349-8919 clinicaltrials@amylin.com

  Show 384 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: Vice President, Research and Development Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by Amylin Pharmaceuticals, LLC.

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

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01144338     History of Changes
Other Study ID Numbers: BCB109
Study First Received: June 10, 2010
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
exenatide once weekly
cardiovascular
Byetta
Amylin
Lilly

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

ClinicalTrials.gov processed this record on June 17, 2013