AstraZeneca reports positive results from extension of DURATION-1 trial of Bydureon

16th June 2014 (Last Updated June 16th, 2014 18:30)

AstraZeneca has reported positive results from the extension of the DURATION-1 trial of exenatide for treatment of patients with type 2 diabetes.

AstraZeneca Headquarters London

AstraZeneca has reported positive results from the extension of the DURATION-1 trial of exenatide for treatment of patients with type 2 diabetes.

Data presented at the 74th Scientific Sessions of the American Diabetes Association (ADA) represents the longest evaluation of a glucagon-like peptide1 (GLP-1) receptor agonist to treat type 2 diabetes to date.

Data shows that Bydureon (exenatide once-weekly) treatment was associated with clinically significant improvements in glycaemic control and weight loss that were sustained over six years in patients who continued therapy.

The results showed that for the 127 patients who completed exenatide once-weekly treatment over six years, HbA1c levels improved significantly from baseline, with almost half (45%) still achieving HbA1c < 7% and almost one third (32%) achieving HbA1c = 6.5%.

In addition, an average weight reduction of 4.3kg from baseline was observed in patients who completed six years of treatment, as well as a reduction in fasting plasma glucose (FPG) of 29mg/dL from baseline.

A total of 295 people were enrolled in the original 30-week randomised, open-label DURATION-1 study, which compared exenatide once-weekly with exenatide twice-daily in type 2 diabetes patients on oral glucose-lowering therapies.

"The DURATION-1 study showed that treatment with Bydureon can help patients reach HbA1c levels that are in line with NICE guidelines and that they can maintain these results through six years of treatment."

According to the company, results showed that treatment with exenatide once-weekly was associated with a greater reduction in HbA1c from baseline than those receiving exenatide twice-daily, with similar weight loss between groups.

AstraZeneca UK and Ireland president Lisa Anson said: "The DURATION-1 study showed that treatment with Bydureon can help patients reach HbA1c levels that are in line with NICE guidelines and that they can maintain these results through six years of treatment.

"Bydureon is the only GLP-1 to offer this level of efficacy combined with a secondary benefit of weight loss, in a single, once-weekly injection."

Data from a separate retrospective study presented at ADA, showed that GLP-1-naive patients with type 2 diabetes were significantly more likely to adhere following initiation of exenatide once-weekly, compared to liraglutide once-daily and exenatide twice-daily.

In the retrospective cohort study in the US, prescription claims data were used to compare proportion of days covered (PDC) as a measure of adherence to the different regimens.

During the six months after GLP-1 initiation, 49% of patients in the exenatide once-weekly group had a PDC of =80%, compared to 44% in the liraglutide once-daily group and 30% in the exenatide twice daily group.


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