TrialWatch
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
This study will test whether a single 14-course treatment with an anti-CD3 monoclonal antibody will prevent the loss of insulin secretion capacity in type 1s who have been diagnosed for a duration of 4-12 months. Previous studies have shown that treatment with CD3 antibodies can preserve residual beta-cell function in type 1s. This is a JDRF/Yale sponsored phase 2 trial started in September 2006 and researchers are looking to enroll 60 participants at the two study sites; Yale University, New Haven (CT) and University of California, San Francisco. Learn More.
Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes
Have you ever had a particularly good week of blood glucose results that you could not wait to share with your doctor or educator? If so, this Diabetech-sponsored study has your name all over it. It will use a special glucose meter to send wireless alerts to a team of healthcare providers of your choice. This will give them a chance to review your glycemic levels before your next appointment. We believe the possible advantages to this are two-fold. Your provider will be better informed when you next see him/her and they would spend less time when you’re in the office looking at logbooks/glucose meters and more time looking at you! Who knows what applications could come – parents could even receive a “blood sugar text message” from their child at school during a hypoglycemic event if the technology takes off. We believe ultimately it’s more about self –management than physician management (the truth is they probably don’t all have time to look through mountains of numbers – it’s probably better for you to look at the key ones! But all these trials will be great for researchers to learn more on the technology so we’re all in favor. The research team is looking for 1000 participants and they expect to complete the study in December 2007.Learn More.
Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus
This NIH/NIDDK sponsored study for overweight, adolescent type 2s will determine whether giving insulin producing beta-cells a break will improve their ability to make insulin. Beta cells can be made to ‘rest’ by giving diazoxide which prevents cells from releasing insulin and supplementing this with insulin from an external source. The One cool thing about this study is that it includes adolescents with and without diabetes. Type 2s undergo treatment with metformin and follow prescribed diets during the two week hospitalization period and patients without diabetes undergo glucose tolerance tests, MRIs, exercise and genetic testing. The study started in March 2007 and will enroll 125 participants. See more details by clicking on the title or pasting the link below into your web browser. Learn More.
Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
In the last issue of diaTribe, we listed Eli Lilly/Alkermes AIR inhaled insulin as one of many inhaled insulins under development. This phase 3 study will test for non-inferiority of HIIP compared to preprandial injectable insulin by doing HbA1c comparisons after 6 months of treatment in type 1 patients. The study will also compare insulin antibody levels in the two groups. This study is open to type 1s who are 18 years and older and have been diagnosed for at least a year. HbA1c must be less than 11% and patients must be taking at least two or three preprandial insulin injections per day for a minimum two- month duration. The study is looking to enroll 320 participants and has an expected completetion date of April 2008. Learn More.