Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

This study will enroll adults with type 2 diabetes mellitus and elevated LDL-C or
non-high-density lipoprotein cholesterol (non-HDL-C) levels on a stable, maximally tolerated
statin dose of at least moderate-intensity at signing of the informed consent; statin therapy
must remain unchanged during screening and the remainder of the study.

Inclusion Criteria:

- Male or female ≥ 18 years

- Type 2 Diabetes Mellitus

- Hemoglobin A1c < 10%

- Stable diabetes therapy

- Must be on maximally tolerated dose of statin of at least moderate Intensity

- Fasting triglycerides ≤ 600 mg/dL

- Not at LDL-C or Non-HDL-C goal.

Exclusion Criteria:

- Moderate to severe renal dysfunction

- Uncontrolled hypertension

- Persistent active liver disease or hepatic dysfunction

- Has taken a cholesterylester transfer protein inhibitor in the last 12 months,

- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary
artery bypass graft or stroke within 3 months prior to randomization