SAVOR-TIMI 53 trial of Onglyza disappoints BMS and AstraZeneca in diabetic vascular outcomes

AstraZeneca and Bristol-Myers Squibb announced top-line results of the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin). In this study of adult patients with Type 2 Diabetes with either a history of established cardiovascular disease or multiple risk factors, Onglyza met the primary safety objective of non inferiority, and did not meet the primary efficacy objective of superiority, for a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke, when added to a patient�s current standard of care (with or without other anti-diabetic therapies), as compared to placebo.

These results are seen as a disappointment to both companies who were hoping to extend the indications of Onglyza into prevention of heart attacks and cardiovascular complications in diabetes patients.