AstraZeneca reports positive results from Phase III trial of exenatide in type 2 diabetes

The trial called DURATION-NEO-1 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.

About 377 patients were enrolled in the randomized, open-label trial conducted across 59 centres.

The company said that 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.

Rockwood Clinic Department of Endocrinology and lead study investigator Carol Wysham said in the trial, the formulation of once-weekly exenatide suspension for autoinjection showed superior reductions in HbA1c as well as similar reductions in weight and other glycaemic measures compared to 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," Wysham said.

Among secondary endpoints, the trial showed that a similar number of patients in the exenatide autoinjection group and Byetta group 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 & Metabolism, Global Medicines Development Elisabeth Björk said the company is committed to better understanding the diverse needs of diabetes patients, including the need for enhanced delivery methods.

"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," Björk said.

Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.