Upstate Active Clinical Trials
Study Title:A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes
What is the purpose of the study?The main purposes of this study are to evaluate cardiovascular events in patients with type 2 diabetes and to test the safety and effectiveness of long-term treatment with ITCA 650 with diet and exercise and standard of care medication(s). ITCA 650 is an investigational drug/device combination which is placed under the skin of the abdomen (belly). This is a small device, about the size of a match. ITCA 650 delivers a specific amount of exenatide to the body every day for as long as it is in place under the skin, up to 6 months. Exenatide is the same drug that is in the FDA-approved drugs Byetta? and Bydureon? given as an injection to treat type 2 diabetes.
Upstate Institutional Review Board (IRB) Number:451303
Patient Age Group:Adults
Principal Investigator:Ruth S Weinstock, MD, PhD
Who is eligible?The study is open to individuals with type 2 diabetes who are at least 40 years old, have HbA1c e 6.5% at screening, and are not currently being treated with rapid-acting insulin.
What is involved if I participate?
- How long is the study?
up to 5 years
- Is transportation provided or reimbursed?
- Is parking provided or reimbursed?
- What tests and procedures are involved?
Participants will come to study visits at the Clinical Research Unit. After the screening visit and a visit at 3 months, all study visits thereafter are every 6 months. Procedures during study visits include: physical exams, blood collection, urinalysis, ECG, questionnaire completion, placement of study device. Subjects will be asked to keep a diary of blood glucose readings throughout the study.
Where will the study take place?Clinical Research Unit, IHP
Other Information:Study drug/device, glucose meters and testing strips will be provided at no cost. All study-related testing and procedures will be performed at no cost to participants.
Who can I contact for more information?
Name: Patricia M Conboy