Bristol-Myers Diabetes Drug Safe After 2 Years, Study Finds

A two-year study of Bristol-Myers Squibb Co.’s and AstraZeneca Plc’s experimental diabetes pill dapagliflozin showed it was safe and effective.

Patients taking dapagliflozin and the generic medicine metformin lowered their blood sugar more than patients on metformin and another generic diabetes drug, glipizide, according to data to be presented tomorrow at the American Diabetes Association’s annual Scientific Sessions in San Diego.

Dapagliflozin is the first entry in a class called SGLT-2 inhibitors that work by allowing patients to excrete their excess blood sugar in their urine. Johnson & Johnson, Eli Lilly & Co., Boehringer Ingelheim GmbH, and Astellas Pharma Inc. are among the companies pursuing similar drugs. Bristol-Myers, based in New York, and London-based AstraZeneca face a regulatory panel next month that will recommend whether dapagliflozin should be approved for use in the U.S.

“Given the reality of diabetes and how difficult it is, endocrinologists will be using it right away” if approved, said Robert Rushakoff, medical director for inpatient diabetes at the University of California, San Francisco, in an interview before the results were released. “I know I’ll be using it right away. It’s easier than teaching someone to inject a medication.”

An estimated 25.8 million Americans have diabetes, most of the Type 2 variety linked to weight gain and a lack of exercise, according to the U.S. National Institutes of Health.

More Infections

Patients on dapagliflozin were more likely to have urinary tract and genital infections than those taking glipizide, the study showed. Excess sugar in dapagliflozin patients’ urine makes it easier for bacteria to grow, causing infections, said Rita Rastogi Kalyani, an assistant professor of medicine at Johns Hopkins University in Baltimore. Most of the infections happened in the first year of the study, the data showed.

Almost 14 percent of dapagliflozin patients had symptoms of a urinary tract infection, compared with 9 percent of glipizide patients. Close to 15 percent of dapagliflozin patients had genital infections, compared with 3 percent of those receiving glipizide.

There was no clinical change in kidney function over the two-year study, the data showed. The drug also produced weight-loss and reduced incidents of low blood sugar compared with glipizide.

Dapagliflozin is scheduled to be reviewed by the U.S. Food and Drug Administration advisory panel on July 19. The study was paid for by the companies.

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