Study targets role of anti-inflammatory drug in fighting diabetes

Researchers are embarking on a multicenter study that targets inflammation as a way to reduce blood glucose levels in people with type 2 diabetes.

If treatment with salsalate, an anti-inflammatory drug used for years to manage arthritis pain, is successful, it could lead to an effective, inexpensive way to treat the most common form of diabetes, the researchers say.

Investigators from 20 medical centers across the country are seeking 560 adults ages 18 to 75 whose glucose levels are not well controlled. Participants may be taking as many as two oral medications but not insulin.

Entry criteria and a listing of study sites for the Targeting Inflammation with Salsalate in Type 2 Diabetes, or TINSAL-T2D, trial can be found online (link).

The study is being funded by the National Institute of Diabetes and Digestive and Kidney Diseases and is a follow-up to promising results of earlier NIDDK-funded studies at the Joslin Diabetes Center in Boston.

That study found blood sugar levels were lowered when salsalate was given for three months. Now researchers want to determine if the drug will be well tolerated and effective over a longer period.

"Given what we've learned about the role of inflammation in the development of type 2 diabetes, this therapy might be getting at an underlying cause of the disease," said principal investigator Steven E. Shoelson, MD, PhD, associate director of research at Joslin and professor of medicine at Harvard Medical School.

Salsalate, a nonsteroidal anti-inflammatory drug, is approved by the Food and Drug Administration to relieve mild to moderate pain, fever, arthritis and other musculoskeletal conditions.

As with all other NSAIDs, salsalate carries a black-box warning for elevating risk for heart attacks and strokes. It also increases the risk of ulcers and stomach bleeding. The prescription drug has been used for decades.

"The outcome of this study has the potential for significant public health benefit," said Myrlene Staten, MD, NIDDK's senior adviser for diabetes translational research. "If salsalate improves the control of type 2 diabetes, we would have a much-needed, inexpensive addition to our arsenal of drug options."

Diabetes' toll on the nation's health has been soaring in recent years because of the obesity epidemic. Type 2 diabetes often leads to complications, including cardiovascular disease, blindness, kidney disease and amputations. People with diabetes die at rates two to four times higher than those who do not have it, according to NIDDK data.