Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2017
Estimated Enrollment :
14752 Patients enrolled
Trial Details
Trial ID
NCT01144338
Start Date
June 18 2010
End Date
April 24 2017
Last Update
August 8 2018
Active Locations (629)
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1
Research Site
Birmingham, Alabama, United States, 35294
2
Research Site
Glendale, Arizona, United States, 85306
3
Research Site
Phoenix, Arizona, United States, 85012
4
Research Site
Jonesboro, Arkansas, United States, 72401