Diabetes Dateline
Spring/Summer 2009

Study Tests Anti-inflammatory Drug for Poorly Controlled Type 2 Diabetes

Researchers in 20 medical centers across the nation are enrolling adults with type 2 diabetes who have poorly controlled blood glucose, also called blood sugar, in the clinical study Targeting Inflammation with Salsalate in Type 2 Diabetes (TINSAL-T2D).

The study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health, 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 is based on the promising results of earlier NIDDK-funded studies at Joslin Diabetes Center in Boston, showing that salsalate effectively lowered blood sugar levels when given for 3 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,” said 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. We hope this drug will provide an additional tool for improving glucose control and thus reducing the risk of diabetes complications.”

Type 2 diabetes often leads to complications, including cardiovascular disease, blindness, kidney disease, and amputations. People with type 2 diabetes die at rates two to four times higher than those who do not have diabetes.

Chemically Similar to Aspirin

Salsalate, which belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), is approved by the U.S. 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,” said co-principal investigator Allison B. Goldfine, M.D., director of clinical research at Joslin and associate professor of medicine at Harvard Medical School.

“The outcome of this study has the potential for significant public health benefit,” said Myrlene Staten, M.D., NIDDK 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.”

Enrollment Criteria

For the TINSAL-T2D study, researchers are seeking adults ages 18 to 75 with poorly controlled blood glucose levels. Participants may be taking no more than two oral medications but not insulin. For other entry criteria and a list of sites participating in the study, go to www.ClinicalTrials.gov and search for trial NCT00799643. For more information about the study, see http://tinsalt2d.org or contact Dr. Goldfine at 617–732–2643, Allison.Goldfine@ joslin.harvard.edu.

For more information about diabetes, including health information for the public, visit www.diabetes.niddk.nih.gov.

NIH Publication No. 09–4562
August 2009

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