The Associated Press September 20, 2010, 8:19AM ET

Bristol-Myers says diabetes drug meets study goal

The drugmakers Bristol-Myers Squibb Co. and AstraZeneca PLC said Monday that their experimental diabetes drug dapagliflozin met its goal in a clinical trial, as the drug was more effective than an older treatment at reducing blood sugar levels.

Dapagliflozin is an oral drug intended to be taken once a day. It is designed to help type 2 diabetes patients excrete glucose and related calories in their urine. That would help prevent glucose from building up in the body.

The companies said a combination of dapagliflozin and glimepiride was better at reducing blood sugar levels than glimepiride and a placebo. Patients on dapagliflozin also lost more weight, had greater oral glucose tolerance, and lower blood sugar levels between meals after the 24-week late stage clinical trial, the companies said.

Patients took either 2.5 milligrams, 5 milligrams, or 10 milligrams of dapagliflozin per day, and the companies said those patients had median weight loss of 2.6 pounds, 3.4 pounds, and 5 pounds respectively. Patients on glimepiride alone had median weight loss of 1.6 pounds. They said rates of side effects were similar for dapagliflozin and glimepiride, but patients on dapagliflozin were more likely to have genital tract infections.

Glimepiride is marketed under names including Amaryl. It was first approved in 1995.

Results from the trial were presented at a meeting of the European Association for the Study of Diabetes in Stockholm. Bristol-Myers Squibb is based in New York, and AstraZeneca is based in the U.K.


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