The randomised, double-blind, placebo-controlled study evaluated the drug in 16,500 patients with Type 2 diabetes who had a history of established cardiovascular disease or multiple risk factors, with or without renal impairment.
The results showed that the trial achieved its primary safety endpoint of non inferiority, but failed to meet the primary efficacy goal 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), versus placebo.
These findings will be submitted to the European Society of Cardiology (ESC) for potential presentation at the ESC Congress in September, the companies added.
As of June, Onglyza has been filed for regulatory approval in 95 countries and is authorised in 86 countries worldwide.
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