Study: no new benefits for diabetes drug Onglyza

Bristol-Myers, AstraZeneca say diabetes pill Onglyza didn't reduce problems like heart attacks

Associated Press

NEW YORK (AP) -- Bristol-Myers Squibb Co. and AstraZeneca PLC said Wednesday their diabetes drug Onglyza did not reduce heart attacks, strokes, or death from cardiovascular causes compared to a placebo.

The companies said Onglyza was not inferior to placebo but did not work significantly better than a sham treatment. The trial was designed to determine if Onglyza can help patients by reducing the risk of non-fatal heart attacks and ischemic strokes and death from cardiovascular problems in addition to its main purpose, lowering blood sugar levels. The companies said they will present more details from the study at a scientific conference in September.

The trial involved 16,500 patients who had diabetes as well as a history of heart disease or multiple risk factors. Patients continued to take their regular diabetes treatments and also took Onglyza or a placebo.

Onglyza is a once-per-day pill that increases insulin production while reducing glucose production. It was approved in 2009. As part of that approval the Food and Drug Administration required Bristol-Myers and AstraZeneca to run another study to investigate any additional benefits for the drug. The trial began in 2010.

The companies sell several diabetes drugs together, including Onglyza, Kombiglyze, Bydureon and Byetta. Kombiglyze contains Onglyza and metformin, an older diabetes drug. In the first quarter of 2013 sales of Onglyza and Kombiglyze grew 25 percent to $202 million.

Shares of New York-based Bristol-Myers lost 27 cents to $46.58 in morning trading. U.S.-listed shares of AstraZeneca, London, fell 17 cents to $50.81.

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