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| |  NIH Tests Rezulin as Part of Prevention Study ROCKVILLE, Md., Jan. 30, 1997. Can a new drug approved today by the FDA to treat Type 2 diabetes be effective also in preventing the disease? As part of the Diabetes Prevention Program, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is seeking to determine whether troglitazone (REZULIN) can prevent or delay the disease in people at risk for it. David M. Nathan, M.D., the study chairman, said today that, if successful, troglitazone may be used to help millions of Americans who are at risk for diabetes control their glucose (blood sugar) levels and avoid developing diabetes. "Troglitazone has been proven safe and effective in lowering glucose levels in people with diabetes," says Nathan. "We are hopeful that this same drug can help people whose glucose level is moderately elevated -- but who do not yet have diabetes -- to lower it or keep it from climbing any higher into the range classified as diabetes. If this can be accomplished, troglitazone may be used not only to treat diabetes but to prevent it." Troglitazone, manufactured under the brand name REZULIN, re-sensitizes the body to insulin by stimulating a gene to produce more insulin-controlled proteins. In turn, these proteins remove excess glucose from the bloodstream giving insulin a better chance of doing its job. Nathan said that the Diabetes Prevention Program, launched last year, is seeking 4,000 men and women over age 25 who are at risk for developing Type 2 diabetes -- including people with a family history of diabetes, overweight individuals, and women who had diabetes during pregnancy (gestational diabetes). Volunteers are screened for a condition called "impaired glucose tolerance" (IGT), which means they have high blood sugar, but not high enough to be diagnosed as diabetes. Volunteers are randomly assigned to one of four groups: troglitazone; metformin, another drug used to treat Type 2 diabetes; an intensive diet and exercise program; and a standard, or control, group. "We are confident that one or more of the interventions will be effective in preventing or delaying the development of Type 2 diabetes," said Nathan. Twenty-five medical centers nationwide are participating in the Diabetes Prevention Program. Anyone interested in joining the study can call 1-888-377-5646 (1-888-DPP-JOIN) for a list of participating centers. The Diabetes Prevention Program is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health. It also is supported by the National Institute of Child Health and Human Development, National Institute on Aging, Office of Research on Minority Health, Office of Behavioral and Social Science Research, Indian Health Service, Centers for Disease Control and Prevention, and the American Diabetes Association. Corporate support is being provided by Parke-Davis (troglitazone), Bristol-Myers Squibb Company (metformin), Lipha Pharmaceuticals, Inc., and Sankyo Pharmaceutical Co.
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