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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Exenatide; Liraglutide; Metformin

Criteria

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.