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

Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of thefollowing 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 ofcontraception 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 receptoragonist.

• Patient is enrolled in another experimental protocol which involves the use of aninvestigational drug or device, or an intervention that would interfere with theconduct 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 (MultipleEndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.