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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT02638805

Run by

Intarcia Therapeutics

People needed

136

Starts

2015-12-01

Expected to finish

2017-10-01

Last updated by the study team

2018-11-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Saint Vincent's Medical Center (BRANY) — Gulf Shores, Alabama, United States
• Arkansas Primary Care Clinic, PA — Little Rock, Arkansas, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver VA Medical Center — Denver, Colorado, United States
• Meridien Research — Brooksville, Florida, United States
• International Research Associates, LLC — Hialeah, Florida, United States
• Care Partners Clinical Research, LLC — Jacksonville, Florida, United States
• AMPM Research Clinic — Miami, Florida, United States
• Epocrates Medical and Research Center — Miami, Florida, United States
• Sensible Healthcare, LLC — Ocoee, Florida, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• American Health Network of Indiana, LLC — Avon, Indiana, United States
• American Health Network of Indiana, LLC — Franklin, Indiana, United States
• American Health Network of Indiana, LLC — Greenfield, Indiana, United States
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Center for Advanced Medical Research — City of Saint Peters, Missouri, United States
• Radiant Research — St Louis, Missouri, United States
• Accent Clinical Trials — Las Vegas, Nevada, United States
• Palm Research Center, Inc. — Las Vegas, Nevada, United States
• Manhattan Medical Research — New York, New York, United States
• Novel Research of New York — The Bronx, New York, United States
• Carteret Medical Group, LLC — Morehead City, North Carolina, United States
• Prestige Clinical Research — Franklin, Ohio, United States

Full record on ClinicalTrials.gov

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