Astrazeneca’s Bydureon EXSCEL trial meets primary safety objective in type-2 diabetes patients

AstraZeneca announced that its Bydureon phase IIIb/IV EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial top-line results and met its primary safety objective of non-inferiority for MACE.

These results address the USFDA requirement that medicines to treat T2D are not associated with an increase in CV risk. Fewer CV events were observed in the Bydureon arm of the trial, however, the efficacy objective of a superior reduction in MACE did not reach statistical significance. Data were consistent with the known safety profile of Bydureon.

AstraZeneca Vice President Global Medicines Development, Elisabeth Björk said that these top-line results from the EXSCEL trial provide robust evidence of the cardiovascular safety profile of Bydureon across a wide range of patients with type-2 diabetes. Furthermore, the trial design and broad inclusion criteria of EXSCEL offer physicians relevant data applicable to clinical practice.

The EXSCEL trial is the largest and most inclusive patient population of any CV outcomes trial of the glucagon-like peptide-1 (GLP-1) receptor agonist class conducted to date, having included more than 14,000 patients from 35 countries. A full evaluation of the EXSCEL data will be presented at the European Association for the Study of Diabetes (EASD) annual meeting on Thursday, 14 September 2017 in Lisbon, Portugal.