TrialWatch May/June, 2009

Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

ClinicalTrials.gov Identifier: NCT00419562

The face of type 1 diabetes has changed greatly in the last decades. We now know that type 1 diabetes is an autoimmune disorder: it results when the immune system mistakenly attacks the beta cells, the body’s natural source of insulin. Recent findings suggest that early administration of insulin by mouth, before the onset of the disease, may desensitize the overactive immune system to the presence of insulin – thereby preventing the development of diabetes.

This study - which received a plug in this year's Banting Lecture, typically one of the most important talks at the ADA Scientific Sessions - examines the preventative effects of oral insulin in individuals at risk for developing type 1 diabetes. To be considered, participants must not have diabetes but be at high-risk for development - i.e., have a near relative who was diagnosed with type 1 diabetes before age 40 and started insulin therapy within one year of diagnosis. In addition, if you meet these criteria your doctor will need to do antibody testing to determine if you are eligible. If the relative is a parent, sibling, or a child, participants must be 3 to 45 years old; if the relative is a niece, nephew, aunt, uncle, grandparent, cousin, or half-sibling, participants must be 3 to 20 years old. This study is recruiting at 36 locations worldwide (and chaired by diaTribe advisory board member Dr. Jay Skyler of the University of Miami!). To find a center near you, visit the link above and look under “Contacts and Locations.”

Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II (TINSAL-T2D-II)

ClinicalTrials.gov Identifier: NCT00799643

The mechanisms underlying type 2 diabetes are still not completely understood. While many possibilities have been proposed, mounting evidence indicates that chronic inflammation (a prolonged immune reaction involving the simultaneous healing and destruction of cells) may play a role. This study investigates whether a common anti-inflammatory agent, salsalate (similar to aspirin), can improve blood sugar control in patients with type 2 diabetes. While the trial is also examining the safety of salsalate in type 2 patients, the drug has been widely used to treat arthritis and is in the non-steroidal anti-inflammatory drug (NSAID) class, which includes such everyday drugs as aspirin and ibuprofen. To be considered for enrollment, subjects must be between the ages of 18 and 75 and have an A1c greater than 7.0% and less than 9.5%. They also must have been diagnosed with type 2 diabetes at least eight weeks before screening. Subjects taking Avandia or Actos in the last six months or Byetta in the last three months may not apply. To enroll, contact allison.goldfine@joslin.harvard.edu.

Continuous Glucose Monitoring in Patients With Type 2 Diabetes (CGM)

ClinicalTrials.gov Identifier: NCT00529815

It seems sometimes that diabetes devices and gadgets are mostly reserved for the type 1 population. However, a number of recent studies have suggested that reducing variability in blood glucose scores is beneficial for anyone with diabetes and can help reduce complications down the line – suggesting the use of continuous glucose monitoring (CGM), which provides a real-time output of blood glucose trends, may have value. How excellent! This study examines whether the additional use of CGM by subjects with type 2 diabetes improves their ability to control glucose levels as compared with standard finger sticking. Participants will use a DexCom CGM device for 12 weeks and be monitored for changes in A1c levels over a total of 52 weeks. To be considered, subjects must be between 18 and 80 years old and have an A1c between 7% and 12%. The trial is currently recruiting in the Washington, DC area – to enroll, contact Mary.Chellappa@amedd.army.mil or call (202) 782-1492.