New Possible Anti-Inflammatory Drug for Poorly Controlled Type 2 Diabetes

The study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is investigating whether salsalate, an anti-inflammatory drug used for years to manage arthritis pain, can reduce blood glucose levels in people with type 2 diabetes. If successful, the trial could lead to an effective, inexpensive way to treat the most common form of diabetes.

The study, registered as NCT00799643 in www.clinicaltrials.gov, is based on the promising results of earlier NIDDK-funded studies at Joslin Diabetes Center in Boston, showing that salsalate effectively lowered blood sugars when given for three months to adults with type 2 diabetes. Now researchers want to determine whether the drug will be well tolerated and effective over a longer period of time.

"This important study is testing whether reducing inflammation with this drug will be an effective treatment for type 2 diabetes," says principal investigator Steven E. Shoelson, M.D., Ph.D., associate director of research at Joslin and professor of medicine at Harvard Medical School. "Given what we’re learning about the role of inflammation in the development of type 2 diabetes, this therapy might be getting at an underlying cause of the disease.”

Salsalate, which belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), is approved by the Food and Drug Administration to relieve mild to moderate pain, fever, arthritis and other musculoskeletal conditions. Chemically similar to aspirin, it has fewer side effects and has been used for more than 40 years to treat pain associated with arthritis. "Recent studies in people show that salsalate also lowers blood glucose, but further testing is needed to determine its long-term safety and efficacy in patients with diabetes," says co-principal investigator Allison B. Goldfine, M.D.

For the TINSAL-T2D study, the researchers are seeking 560 adults ages 18 to 75 whose glucose levels are not well-controlled. Participants may be taking no more than two oral medications but not insulin. For other entry criteria and a listing of sites participating in the study, see http://tinsalt2d.org.