To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Glucophage Selected in Major Diabetes Prevention Trial URL: http://www.pslgroup.com/dg/968E.htm Doctor's Guide June 10, 1996
PRINCETON, N.J., June 10, 1996 -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that GLUCOPHAGE(R) (metformin hydrochloride tablets), the company's oral diabetes medication, has been selected as one of three study interventions in the Diabetes Prevention Program (DPP), a national diabetes research trial to be conducted by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), a division of the National Institutes of Health. GLUCOPHAGE is the only medication currently marketed that is to be included in the trial. One of the largest diabetes trials ever undertaken by the federal government, the DPP objective is to prevent or delay the onset of non- insulin dependent diabetes mellitus (NIDDM), commonly known as type II diabetes, in people at high risk for developing the disease. "Bristol-Myers Squibb is proud to help initiate diabetes prevention by joining in public-private partnership with the NIDDK to conduct the Diabetes Prevention Program," said Dennis R. Cryer, M.D., Vice President, Cardiovasculars/Metabolics Medical, Bristol-Myers Squibb. "We are delighted that the federal government, after careful scrutiny, has selected GLUCOPHAGE as the only marketed medication to be used in the trial. This selection is unmistakable recognition of the unique benefits GLUCOPHAGE offers people with diabetes over other available diabetes medications." DPP's primary objective is to determine if lifestyle and drug therapies are effective in preventing or delaying the development of type II diabetes in people with impaired glucose tolerance (IGT), a condition in which a person's fasting blood glucose levels are higher than normal but have not reached diabetic levels. No medication is presently approved to prevent type II diabetes. Dr. David Nathan, the Study Chairman, stated that, "All of the treatments were chosen on the basis of previous studies that have demonstrated their ability to lower blood sugar levels in patients with impaired glucose tolerance (IGT) and based on their high safety profile and low frequency of side effects." He also stated that each agent's ability to improve various conditions such as high cholesterol and obesity, conditions that can lead to an increased risk for heart disease and stroke, were considered. DPP is seeking to enroll at least 4,000 people with IGT, more than half from high-risk groups -- African Americans, Hispanic Americans, Native Americans, Asian Americans and Pacific Islanders. Study participants will be randomized to one of four groups: intensive lifestyle modification (which includes a diet and exercise program intended to achieve and maintain a 7 percent weight loss); GLUCOPHAGE ; troglitazone, an investigational drug not available for marketing in the United States; and a standard, or control, group. Diabetes affects an estimated 16 million people in the United States, including a disproportionate number of minority populations; about 7 percent of the U.S. adult population has type II diabetes. Type II diabetes is the second leading cause of visits to physicians and the fourth leading cause of death by disease in this country. The disease is responsible for an estimated $100 billion annually in direct and indirect health care costs, amounting to approximately 12 percent of total annual U.S. health care expenditures. GLUCOPHAGE An oral medication indicated as a treatment for type II diabetes when diet alone is inadequate to control blood glucose levels, GLUCOPHAGE has been available in the United States since May 1995. In addition to diet, the medication can be used alone or in combination with the sulfonylureas, another class of oral diabetes medications. GLUCOPHAGE differs from and offers several potential advantages over the sulfonylureas. The sulfonylureas primarily stimulate the body to produce more insulin; however, too much insulin can lead to low blood sugar or hypoglycemia. GLUCOPHAGE is unique in that it improves insulin sensitivity thereby increasing the body's response to its own insulin. Thus, while GLUCOPHAGE alone lowers blood glucose levels as effectively as the sulfonylureas, it does so without producing hypoglycemia, a potentially dangerous condition in which blood glucose levels become too low. GLUCOPHAGE also works without causing weight gain and modestly improves cholesterol and triglyceride levels, which are often elevated in people with diabetes. When it became available last year, GLUCOPHAGE was the first new type of medication cleared for type II diabetes in the United States in 20 years. Within three months of its introduction, the drug became and has remained the most frequently prescribed branded medication to treat type II diabetes in the United States. More than 1 million patients have been placed on GLUCOPHAGE since it was introduced. GLUCOPHAGE usage is contraindicated in patients with abnormal kidney function due to the risk of lactic acidosis, or the build-up of lactic acid in the blood, a rare, but serious metabolic complication that can occur due to GLUCOPHAGE accumulation during treatment. It has been reported to occur in about three out of 100,000 patients who take this drug for a full year. If it occurs, it may be fatal in up to half the cases. The risk of lactic acidosis may be significantly decreased by strict adherence to the prescribing guidelines. Bristol-Myers Squibb is a diversified, worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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