TrialWatch September/October, 2008

Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes

ClinicalTrials.gov Identifier: NCT00315939

This University of Virginia study is investigating the use of computer programs to help prevent hypoglycemia in adults with type 1 diabetes. You're eligible to enter this trial if you are 18 years or older, have type 1 diabetes, and are willing to commit to using the program for up to a year, perform frequent blood glucose testing (3-4x/day), and keep diaries of any hypoglycemic events you may have. We're always looking out for new tools to help you manage hypoglycemia, and we're excited to see people testing some of those tools. The study is hoping to find 120 participants, and is recruiting in Charlottesville, VA. You can contact Pam Mendosa, RN at (434) 982-6481 or pcm9b@virginia.edu for more information.

The DEFEND-1 Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 (Autoimmune) Diabetes Mellitus

ClinicalTrials.gov Identifier: NCT00678886

The JDRF and Tolerx Inc. are teaming up for this study, investigating the use of a powerful immunosuppressive agent, Otelixizumab, (an anti-CD3 monoclonal antibody) in newly diagnosed type 1 diabetes patients. Immunosuppressive drugs have been shown to decrease the immune system's attack on the pancreatic cells that produce insulin, effectively delaying the onset of type 1 diabetes. However, the drugs have to be taken very soon after diagnosis, and so you are only eligible to participate in this study if it has been 90 days or less since your initial diagnosis of type 1. The entire study lasts two years. Initially, the drug will be given once a day for eight days and with regular follow up over the first year and a few times during the second year. The study is recruiting at 30 centers around the country. For more information, you can check out the link above or contact Kathleen Osborn at (877) 515-6672 or at clinicaltrials@tolerx.com.

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and a TZD in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

ClinicalTrials.gov Identifier: NCT00637273

This study run by Amylin and Eli Lilly is looking for type 2 patients on metformin to test a new once-weekly GLP-1 analog (essentially a long-acting form of Byetta) in comparison to other common diabetes drugs. Nearly all adult type 2 patients with an A1c over 7% are eligible. When you enroll, you'll be given a 26-week treatment of either exenatide once weekly (a once-weekly shot), a DPP-4 inhibitor like Januvia, a TZD like Actos, or a placebo. This trial is recruiting at more than 60 centers countrywide, so there's almost certainly a center near you. Check out the link for more information or contact the Amylin Call Center at 1 (800) 349-8919 and mention the DURATION-2 trial. Also see What We're Reading in diaTribe issue 5 for more information on this drug.

Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes

ClinicalTrails.gov Identifier: NCT00322478

This trial is testing a new kind of wireless testing system called GlucoMON. This device sends blood glucose meter data to your health-care team in real-time through a wireless internet connection, allowing your doctor, CDE, and the rest of your management team to track and analyze your numbers. After the trial period, your A1c will be measured and the researchers will check in to see how you liked the GlucoMON. The study is recruiting in Dallas, Texas, and anyone with diabetes (any type) is eligible. Contact Kevin L McMahon, B.S. at (877) My Gluco or kevin@diabetech.net, or Stephen W Ponder, M.D. at (361) 694-4272 ponders@driscollchildrens.org for more information.