Phase III study of Bydureon meets primary endpoints in T2D-AstraZeneca

AstraZeneca announced 28-week results from DURATION-NEO-1, a Phase III study comparing an investigational formulation of Bydureon (exenatide once-weekly suspension for autoinjection) to twice-daily Byetta (exenatide) injection in adult patients with Type 2 Diabetes who had inadequate glycaemic control. The study met its primary endpoint of non-inferiority, demonstrating that exenatide once-weekly suspension for autoinjection provided greater mean reductions in HbA1c (blood glucose levels) compared to Byetta at 28 weeks (-1.4% vs. -1.0%, respectively).

Among secondary endpoints, the study demonstrated that a similar number of patients in the exenatide autoinjection group and Byetta group reached a HbA1c target of < 7% at 28 weeks (49% vs. 43%, respectively); however, more patients in the exenatide autoinjection group achieved further HbA1c reductions to ? 6.5% (36% vs. 26% of patients treated with Byetta). Patients in the exenatide autoinjection group and Byetta group had similar reductions in mean body weight (-1.5 kg vs. -1.9 kg, respectively) as well as reductions in fasting plasma glucose levels (-1.8 mmol/L vs. -1.3 mmol/L, respectively), at 28 weeks. Patients in both the exenatide autoinjection group and Byetta group also experienced improvements in post-prandial glucose (two-hour glucose excursions of 1.7 mmol/L vs. 3.9 mmol/L, respectively) at 16 weeks. The results were presented at the 50th Annual Meeting of the European Association for the Study of Diabetes.