The Phase IV SAVOR-TIMI-53 cardiovascular outcomes trial was conducted in 16,500 type 2 diabetes patients with either a history of established cardiovascular disease or multiple risk factors, with or without renal impairment, in 25 countries.
Onglyza met the primary safety objective of non-inferiority but failed to meet the primary efficacy objective of superiority, meant for a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke, as compared to placebo.
Currently, the companies are analyzing these preliminary SAVOR-TIMI-53 data and yet to submit the results to the European Society of Cardiology (ESC) for future presentation.
Belonging to a class of medicines known as dipeptidyl peptidase-4 (DPP-4) inhibitors, Onglyza is indicated as an adjunct to diet and exercise for adults with type 2 diabetes mellitus to improve glycemic control.