Condition: Diabetes Mellitus, Type 2 · Sponsor: Intarcia Therapeutics
A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 24 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.