More data needed on experimental drug for diabetes: study

Diabetes affects more than 25 million Americans. New medications and strategies to treat the disease are greatly needed. But the jury is still out on the experimental medication dapagliflozin.

The medication looks to have significant benefits and risks, according to a study published Monday. Dapagliflozin is being developed by Bristol-Myers-Squibb Co. in partnership with AstraZeneca. It represents a new class of diabetes medications called selective renal sodium glucose contransporter inhibitors. That means: The medication prompts the kidneys to release sugar so it’s excreted in urine. The medication is aimed at diabetics who are on high doses of insulin but still have poor blood-sugar control.

The study, reported in the Annals of Internal Medicine (click here for the abstract), featured 808 people who were randomly assigned to receive a placebo or dapagliflozin in addition to insulin and other diabetes medications for almost one year. Researchers found that the people on dapagliflozin were able to reduce their doses of insulin and lost more weight than those in the placebo group, but they had more bouts of hyperglycemia.

Not enough is known about the long-term safety of dapagliflozin, said Dr. Steven A. Smith, a professor of medicine at the Mayo College of Medicine in Rochester, Minn., who wrote an editorial accompanying the study.

The Food and Drug Administration in January asked the manufacturers for more data on the drug’s possible cancer risk and how it might affect the liver.

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