Bristol-Myers Squibb Company and AstraZeneca today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial (SAVOR-TIMI 53), a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors. The five-year study will follow approximately 12,000 patients with type 2 diabetes, who have either a history of previous cardiovascular events or multiple risk factors for vascular disease, and includes patients with renal impairment.
The objectives of the SAVOR-TIMI 53 trial are to test the hypothesis of whether treatment with ONGLYZA compared with placebo when added to a patients’ current standard of care will result in a reduction in the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke and to exclude an unacceptable cardiovascular toxicity. The SAVOR-TIMI 53 trial was in part designed to fulfill a post-marketing requirement for the U.S. Food and Drug Administration (FDA), as well as to help answer the important question of potential benefit beyond glucose lowering. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.
Eugene Braunwald, M.D., Chairman, and Deepak L. Bhatt M.D., MPH, Senior Investigator of the TIMI Study Group, in conjunction with Itamar Raz, M.D., Head of the Diabetes Unit at the Hadassah University Medical Center, Jerusalem, will serve as principal investigators and conduct the trial for Bristol-Myers Squibb and AstraZeneca.
"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.