AstraZeneca and Bristol-Myers Squibb (BMS) diabetes drug Onglyza (Saxagliptin) has failed to meet the primary efficacy objective of superiority in Phase IV SAVOR-TIMI-53 cardiovascular outcomes trial.
Onglyza, which met the primary safety objective of non-inferiority, failed to demonstrate superiority in reducing cardiovascular deaths, non-fatal myocardial infarction or non-fatal ischemic stroke compared with placebo in type 2 diabetes patients.
Conducted at more than 700 sites globally, the randomised, double-blind, placebo-controlled SAVOR trial was led by the academic research organisations TIMI Study Group and Hadassah University Medical Center.
A total of 16,500 type 2 diabetes patients, with either a history of established cardiovascular disease or multiple risk factors, with or without renal impairment, from 25 countries were enrolled in the study.
Onglyza was administered to the study's subjects in addition to a patient's current standard of care, with or without other anti-diabetic therapies, and was compared with the placebo.
The preliminary SAVOR-TIMI-53 results are currently being analysed by the companies and the study results will be submitted to the European Society of Cardiology (ESC) for probable presentation in September.
Indicated as an adjunct to diet and exercise for adults with type 2 diabetes mellitus in multiple clinical settings to improve glycemic control, Onglyza is cleared in 86 countries, including those in the European Union, the US, Canada, Mexico, India, Brazil and China as of June 2013.
Image: A Bristol-Myers Squibb R&D facility Princeton Rd, Princeton, New Jersey, US. Photo: Original uploader was Coolcaesar at en.wikipedia.