Upstate Active Clinical Trials Seeking Participants
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.
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.
Who is the doctor administering the study?
Ruth S. Weinstock, MD, PhD
Where will the study take place?
Clinical Research Unit, IHP
Over what time period is the study scheduled to run?
June 2013 until enrollment is met
Who can I contact for more information?
- Name: Patricia Conboy
- Phone: 315-464-9007
- Email: firstname.lastname@example.org
- Fax: 315-464-9076
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.
If you are interested in this trial, please contact the study coordinator or investigator noted above.