TrialWatch
Phase 2 Study of ITCA 650 (DUROS Continuous Delivery of Exenatide) in Patients with Type 2 Diabetes
ClinicalTrials.gov Identifier: NCT00943917
This study will directly compare ITCA 650 (Intarcia’s continuous delivery of exenatide) therapy to Byetta (currently on the market twice-daily exenatide, sold by Eli Lilly) therapy in type 2 patients of diabetes. The study is designed to both directly compare ITCA 650 to Byetta and to help discover the doses at which ITCA 650 can achieve the best results. Study participants will be treated with different doses of ITCA 650 or twice daily injections of Byetta for six months. ITCA 650 treatment consists of exenatide delivered through a matchstick-size miniature pump that is inserted below the skin that will provide constant drug delivery while it remains implanted for three months at a time. Both men and women ages 18-70 years old and diagnosed with type 2 diabetes for six months or longer will be eligible to participate in the study. Patients must also be on a stable treatment regimen of metformin for more than three months prior to the first screening visit, have a BMI of less than or equal to 40 kg/m2, and no history of type 1 diabetes or diabetic ketoacidosis.. Patients cannot participate in the study if they have had prior treatment with Byetta. There are over 47 study sites across the country, divided between 22 states including California, Colorado, Florida, Georgia, Illinois, Michigan, Minnesota, New York, North Carolina, Ohio, and Texas, among several others. To enroll, call 866-872-2349.
Phase 2 Study of Thymoglobulin to Arrest Newly Diagnosed Type 1 Diabetes (START)
ClinicalTrials.gov Identifier: NCT00515099
The START study will explore the use of thymoglobulin (commonly used to treat the immune response in patients following organ transplantation) to halt the progression of newly diagnosed type 1 diabetes when delivered within 12 weeks of diagnosis. Study participants will either receive thymoglobulin or placebo daily; the duration of the study is two years. Thymoglobulin interacts with the white blood cells involved in the body’s immune response known as T cells, some of which are believed to be responsible for the immune system’s attack on the pancreas in type 1 diabetes. In treating or preventing organ transplant rejection, thymoglobulin can block regular T cell function and temporarily eliminate a substantial proportion of T cells from the bloodstream. Patients eligible for this study will be between 12 to 35 years old with a diagnosis of type 1 diabetes made within 12 weeks prior to entry in the study. Patients with any active infection, history of significant cardiac disease, use of diabetes medications other than insulin, liver failure, kidney disease, or current or intention to become pregnant will be excluded from the study. There are study sites in California, Colorado, Minnesota, Missouri, and Pennsylvania – to enroll, contact Marcia Wertz at (415) 514-3597 or info@type1diabetestrial.org.
Cardiovascular Outcomes Study of Alogliptin in Subjects with Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE)
ClinicalTrials.gov Identifier: NCT00968708
The EXAMINE study is designed to determine if alogliptin influences cardiovascular health differently than placebo in type 2 diabetes patients with acute coronary syndrome. Alogliptin is a new DPP-4 inhibitor (similar to Merck’s Januvia) manufactured by Takeda Pharmaceuticals that has been shown through five other trials to be effective in reducing A1c as both taken alone and as an additional therapy to other antidiabetic medications. As a reminder, no additional risk for adverse cardiovascular outcomes has been observed in this class of drugs to date; however, the FDA feels more long-term study of the safety of this drug in high-risk patients is warranted. Patients in the EXAMINE study will be treated with different doses of alogliptin (low, medium, or high dose) or placebo for up to 4.75 years. In order to be included in the study, patients must have a diagnosis of type 2 diabetes and a diagnosis of acute coronary syndrome within 15-60 days of entry into the study. Patients with A1c values between 7% and 10% will be accepted, except in the case of insulin use, in which case patients should have an A1c between 7% and 9%. Patients will be excluded if they have signs of type 1 diabetes or are currently being treated with Byetta at entry or have been treated with a DPP-4 inhibitor for more than 14 days total or within the three months prior to entry into the study. Over 5,000 patients will be enrolled at over 40 study locations represented in twenty states including California, Texas, Alabama, Florida, Michigan Pennsylvania, New York, Massachusetts, and Illinois, among several others. For more information on how to enroll, call 800-778-2860 or e-mail medicalinformation@tpna.com.