AstraZeneca and Bristol-Myers Squibb have announced the full results of the SAVOR clinical trial of Onglyza (saxagliptin) in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events.
In this study, Onglyza met the primary safety objective, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo. Onglyza did not meet the primary efficacy endpoint of superiority to placebo for the same composite endpoint. Patients treated with Onglyza experienced improved glycemic control and reduced development and progression of microalbuminuria over two years as assessed in exploratory analyses.
The major secondary endpoint of cardiovascular death, non-fatal MI, non-fatal ischemic stroke or hospitalization for heart failure, unstable angina or coronary revascularization was balanced across the two arms. One component of the secondary endpoint, hospitalization for heart failure, occurred more in the Onglyza group compared to placebo. Rates of pancreatitis were low and balanced between Onglyza and placebo. Overall rates of malignancy were balanced, and the observed rates of pancreatic cancer were lower in the Onglyza group than in the placebo group. More patients in the Onglyza group reported at least one hypoglycemic event compared to placebo.
The study, led by the academic research organizations TIMI Study Group and Hadassah University Medical Center and conducted at more than 700 sites worldwide, SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) was a randomized, double-blind, placebo-controlled trial of 16,492 patients designed to evaluate the cardiovascular safety and efficacy of Onglyza (saxagliptin) in adults with type 2 diabetes at risk for cardiovascular death, heart attack and stroke, compared to placebo.
Results were published in The New England Journal of Medicine.
Onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. Onglyza should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.