Bydureon EXSCEL Trial Meets Primary Safety Objective in Type 2 Diabetes Patients at Wide Range of Cardiovascular Risk

May, 2017

May 23, 2017. Top-line results from the Phase IIIb/IV EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial have been announced by the drug’s manufacturer. The trial compared once-weekly injectable extended-release exenatide (Bydureon) vs placebo in adults with type 2 diabetes (T2D) and a wide range of cardiovascular (CV) risk profiles. More than 14,000 patients from 35 countries participated. The primary outcome was a composite of major adverse cardiac events (MACE): CV death, nonfatal myocardial infarction, or nonfatal stroke. The EXSCEL trial met its primary safety objective of non-inferiority for MACE, addressing the US Food and Drug Administration requirement to assess CV risk in T2D medicines. The efficacy objective of superior reduction in MACE with Bydureon did not reach statistical significance, although fewer CV events occurred in the Bydureon trial arm. More detailed study results will be presented at the European Association for the Study of Diabetes meeting in September 2017.