AstraZeneca and Bristol-Myers Squibb have announced disappointing results of their diabetes drug, Onglyza, which failed to reduce heart risks in phase 4 clinical trials.
The SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial was evaluating Onglyza (saxagliptin) in adult patients with type 2 diabetes who either had a history of established cardiovascular disease or multiple risk factors. In this trial, Onglyza met the primary safety objective of non inferiority, but 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.
The preliminary trial data are now being analysed and the results will be submitted to the European Society of Cardiology (ESC) for potential presentation at the ESC Congress in September.
AstraZeneca, Bristol diabetes drug fails to show heart benefit (Reuters)
AstraZeneca press release