Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

Inclusion Criteria:

- Diagnosis of type 2 diabetes ≥ 3 months.

- Stable regimen of diet and exercise in combination with a stable treatment of
liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.

- HbA1c ≤9.5%.

- Stable body weight ≥ 3 months.

- Body mass index (BMI) ≥25 to ≤45 kg per meter squared.

- Calcitonin <50 ng/L (50 pg/mL) at the Screening Visit.

Exclusion Criteria:

- History of type 1 diabetes.

- Recent use or of anti-diabetic medications other than liraglutide or metformin.

- History of significant/severe nausea and/or vomiting due to liraglutide.

- Significant symptomatic hyperglycemia.

- History or evidence, within the last 6 months prior to the Screening Visit, of
myocardial infarction, coronary revascularization (coronary artery bypass grafting or
percutaneous coronary intervention), unstable angina, or cerebrovascular accident or
stroke.

- History or evidence of acute or chronic pancreatitis.

- History of liver disease.

- History of medullary thyroid cancer or a family or personal history of multiple
endocrine neoplasia type 2.

- Poor thyroid, liver, or renal function.

- Serum creatinine levels >1.5mg/dL (132 μmol/L) for male patients, or >1.4 mg/dL (123
μmol/L) for female patients.

- Weight loss surgery or requires weight loss medications.

- History of malignancy (not including basal or squamous cell carcinoma of the skin with
past 5 years).

- History of active alcohol or substance abuse.

- Treatment with medications that affect GI motility.

- History of hypersensitivity to exenatide or liraglutide.

- Women that are pregnant, lactating, or planning to become pregnant.