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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01144338

Run by

AstraZeneca

People needed

14752

Starts

2010-06-18

Expected to finish

2017-04-24

Last updated by the study team

2018-08-08

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Glendale, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Chula Vista, California, United States
• Research Site — Concord, California, United States
• Research Site — Escondido, California, United States
• Research Site — Fullerton, California, United States
• Research Site — Greenbrae, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Laguna Hills, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Northridge, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Orange, California, United States
• Research Site — Redondo Beach, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — Sylmar, California, United States
• Research Site — Torrance, California, United States
• Research Site — Tustin, California, United States
• Research Site — Victorville, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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