Bristol-Myers Squibb, AstraZeneca announce postmarketing study for Onglyza

WILMINGTON, Del. Two drug makers hope to find out how well a diabetes drug works in treating patients who run the risk of developing cardiovascular diseases in a post-marketing study announced Tuesday.

Bristol-Myers Squibb and AstraZeneca announced the start of a phase 4 study of 12,000 patients with Type 2 diabetes treated with the drug Onglyza (saxagliptin). The placebo-controlled study, called SAVOR-TIMI 53, will take place over a five-year period and follow patients who have a history of previous cardiovascular problems or multiple risk factors for vascular disease, with the goal of determining whether adding Onglyza to their current standard of care will reduce their risk of cardiovascular death, heart attack or stroke.

The Food and Drug Administration approved Onglyza in July 2009.