First Large DM Outcomes Study Finds Saxagliptin Not Superior to Placebo
The SAVOR-TIMI-53 cardiovascular outcomes trial of saxagliptin was unable to meet the primary efficacy objective of superiority over placebo in terms of reducing a composite end-point of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke, when combined with a patient with type 2 diabetes’ current standard of care. However, saxagliptin did meet the primary safety objective of non-inferiority, according to a June 19 announcement of the top-line results by trial sponsors AstraZeneca and Bristol-Myers Squibb.
The study sought to test the results of saxagliptin — known also as Onglyza® — as an aide to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It included 16,500 patients with type 2 diabetes with a history of cardiovascular disease or multiple risk factors, and included more than 700 sites and 25 countries.
Results for this trial are under analysis and have been submitted to the European Society of Cardiology (ESC) for a possible presentation in Amsterdam during the ESC Congress this September.
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