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

An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

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.