New and effective diabetes drug seeking approval

By Dr. Ananya Mandal, MDJun 27 2011

A new drug for diabetes from Bristol-Myers Squibb Co. and AstraZeneca PLC was effective in lowering blood sugar. The pharmaceutical drug makers are looking for approval for the drug, dapagliflozin, as the first in new class of pills designed to lower blood sugar by increasing the amount of glucose excreted in the urine.

Dapagliflozin is the most advanced candidate in a new class of drugs known as sodium-glucose co-transporter-2 inhibitors. Johnson & Johnson, Boehringer Ingelheim GmbH and Astellas Pharma Inc. also are developing such drugs.

The drug is under review at the Food and Drug Administration, and an FDA advisory panel will consider the drug at a meeting July 19. London-based AstraZeneca and Bristol-Myers, of New York, released two studies and a safety update on dapagliflozin over the weekend at the annual meeting of the American Diabetes Association.

One of the studies looked at three doses of the drug and a placebo, or sugar pill, when added to a common diabetes drug, metformin. The other study compared dapagliflozin with glipizide, another common diabetes treatment. Results of both the studies showed dapagliflozin was more effective at lowering A1C hemoglobin levels, a common measurement of blood glucose, compared with patients on a placebo and other diabetes medications. The studies also showed that dapagliflozin-treated patients lost a small amount of weight compared with patients receiving a placebo.

The research teams said genital and urinary-tract infections were more common in patients taking dapagliflozin than in patients taking placebos and other diabetes drugs. The rate of such infections was about 12% to 14% for patients being treated with dapagliflozin, compared with about 5% for those taking metformin.

The companies said there was no difference in rates off all types of cancer, though rates of bladder and breast cancers were higher in people on the new drug. Most of the cancers were diagnosed in the first year of the studies, which the companies said makes it unlikely the drug played a role, as cancers usually take longer to develop. According to Dr. Joel Zonszein, the director of the Clinical Diabetes Center at Montefiore Medical Center in New York, it was “very unlikely” that dapagliflozin contributed to the cancers. Also, patients with diabetes generally have higher rates of cancer compared with people without diabetes, he said. Dr. Zonszein said he isn't involved in research related to dapagliflozin or its competitors.

Diabetes affects about 26 million Americans and is characterized by high blood glucose levels caused by the body's inability to either make or properly use insulin. In Type 2 diabetes, the most common form of diabetes, the body doesn't produce enough insulin or cells ignore or don't use the insulin.

Bristol-Myers Squibb and AstraZeneca have been working together on drugs for Type 2 diabetes since 2007.