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 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.