AstraZeneca’s Phase III trial of diabetes drug exenatide meets primary endpoint

21st September 2014 (Last Updated September 21st, 2014 18:30)

AstraZeneca has reported positive results from its Phase III trial (DURATION-NEO-1) of exenatide to treat adult patients with type 2 diabetes.

AstraZeneca has reported positive results from its Phase III trial (DURATION-NEO-1) of exenatide to treat adult patients with type 2 diabetes.

The 28-week trial compared an investigational formulation of exenatide once-weekly suspension for autoinjection with twice-daily exenatide (Byetta) injection in these patients who had inadequate glycaemic control.

A total of 377 patients were enrolled in the randomised, open-label trial conducted across 59 centres.

The trial met its primary endpoint of non-inferiority, showing that exenatide once-weekly suspension for autoinjection provided greater mean reductions in HbA1c (blood glucose levels) compared to Byetta at 28 weeks.

"The results provide evidence of the tolerability and efficacy of this investigational formulation of once-weekly exenatide suspension delivered through a single-use autoinjector."

The results of the trial were presented at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.

Rockwood Clinic Department of Endocrinology and lead study investigator Dr Carol Wysham said: "In this study, the formulation of once-weekly exenatide suspension for autoinjection demonstrated superior reductions in HbA1c, as well as similar reductions in weight and other glycaemic measures compared with Byetta.

"The results provide evidence of the tolerability and efficacy of this investigational formulation of once-weekly exenatide suspension delivered through a single-use autoinjector."

Among secondary endpoints, the trial showed that a similar number of patients in both the exenatide autoinjection and Byetta groups reached a HbA1c target of less than 7% at 28 weeks, while more patients in the exenatide autoinjection group achieved further HbA1c reductions to less than or equal to 6.5%.

AstraZeneca head of cardiovascular and metabolism and global medicines development Elisabeth Björk said: "The results from DURATION-NEO-1 support our continued commitment to diabetes patients through developing this new formulation of exenatide once-weekly suspension for autoinjection and investigating a new delivery device."

During the trial, patients who were not achieving adequate HbA1c control using diet and exercise or other oral anti-diabetic medications were given 2mg of exenatide once-weekly suspension for autoinjection or Byetta 10mg.