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National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK)

For Immediate Release
Tuesday, February 3, 2009

Joan Chamberlain

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

Researchers in 20 medical centers across the country are enrolling adults with type 2 diabetes who have poorly controlled blood glucose to participate in a 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), 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. We hope that 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.

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., 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’s senior advisor 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."

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 be taking insulin. For other entry criteria and a listing of sites participating in the study, see www.clinicaltrials.gov. Those volunteering to participate in the study will undergo a variety of tests to determine if they are eligible. Participants selected for the study, who can expect their involvement to last about a year, may receive the study drug or a placebo. A placebo is an inactive pill that looks like the study drug but contains no active medication. Placebos are used to determine if the results of the study are truly from the study drug. TINSAL-T2D study participants will receive all study-related medication and treatments free of charge and will continue to see their personal physician for all their health care needs. For more information about the study, see http://tinsalt2d.org or contact Allison B. Goldfine, M.D., at 617-732-2643 or Allison.Goldfine@joslin.harvard.edu.

NIDDK, part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit www.niddk.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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