"One of the objectives of the SAVOR-TIMI 53 study is to test superiority of treatment with ONGLYZA versus placebo when added to current therapy, as well as exclude unacceptable cardiovascular risk," said Eugene Braunwald, M.D., Chairman of the TIMI Study Group.

ONGLYZA has been submitted for regulatory review in more than 50 countries and is approved in 38 countries, including the United States and European Union. ONGLYZA was approved by the U.S. FDA in July 2009. ONGLYZA (saxagliptin) is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. ONGLYZA once daily can be used in combination with commonly prescribed oral anti-diabetic medications “ metformin, sulfonylureas or thiazolidinediones (TZD) “ or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). ONGLYZA has not been studied in combination with insulin.

Source Bristol-Myers Squibb