UK-based AstraZeneca has reported results from its longest, randomised, head-to-head DURATION-3 trial of exenatide once-weekly, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist used to treat type 2 diabetes in adult patients uncontrolled on oral antidiabetic drugs.
The trial compares a long-acting GLP-1 receptor agonist with basal insulin (insulin glargine) in type 2 diabetes patients with suboptimum glycaemic control despite maximum tolerated doses of metformin alone, or with a sulfonylurea.
Data from the trial published in the Lancet Diabetes and Endocrinology demonstrates that Bydureon (exenatide once-weekly injection) can achieve better glycaemic control with weight loss and less hypoglycaemia, compared with treatment from insulin glargine, over three years.
"Exenatide once-weekly also demonstrated lower incidence of hypoglycaemia and improved levels of patient quality of life, combined with the convenience of a once-weekly injection rather than a daily insulin injection."
In the trial's primary efficacy analysis at 156 weeks, treatment with exenatide once-weekly showed a greater mean reduction in HbA1c from baseline compared with those treated with insulin glargine.
In addition, overall rates of hypoglycaemic events per patient, per year, were shown to be three times lower in patients given exenatide once-weekly compared with insulin glargine.
Sandwell and West Birmingham Hospitals NHS Trust consultant physician in diabetes Bob Ryder said the DURATION-3 trial shows the superiority of exenatide once-weekly over traditional insulin therapy in appropriate patients.
"Even when using a 'treat to target' protocol with insulin, exenatide once-weekly achieved better HbA1c levels, with the additional benefit of weight loss, versus weight gain often seen in patients on insulin therapy," Ryder said.
A total of 456 patients, across 72 trial sites, worldwide, were enrolled in trial and they were randomised to receive at least one dose of the assigned drug.
In the trial, 233 patients received once-weekly exenatide (2mg subcutaneous injection), 223 patients received once-daily insulin glargine (titrated to target) given in addition to their existing oral glucose-lowering treatments.
The core study's primary endpoint was change in HbA1c at week 26 compared with baseline, while the primary efficacy analysis for this extension phase of the study was the change in HbA1c at week 156 from baseline.
AstraZeneca president of UK and Ireland Lisa Anson said: "These long-term clinical data support the established efficacy and safety profile that are central to the Bydureon value proposition for both the NHS and patients with type 2 diabetes, in addition to the benefit of once weekly administration."