Positive results from type 2 drug combination trial
The combination of a GLP-1 receptor agonist and an SGLT-2 inhibitor has shown positive results in those with type 2 diabetes who do not respond to metformin.
The DURATION-8 trial showed Bydureon® (exenatide once-weekly) 2mg once weekly in combination with Forxiga® (dapagliflozin) 10mg once daily significantly reduced HbA1c.
John Wilding, professor of medicine and honorary consultant physician at University Hospital Aintree in Liverpool, said: “DURATION-8 is the first study of its kind to examine how this particular combination of medicines and their differing modes of action can benefit patients with type 2 diabetes.
“Given the progressive nature of type 2 diabetes and the need for multiple treatment options to help patients achieve and maintain glycaemic control, the results of this study are encouraging.”
The DURATION-8 data give an encouraging insight into the potential benefits of combining exenatide once-weekly and dapagliflozin
The trial achieved its primary endpoint with the combination of exenatide once-weekly and dapagliflozin significantly reducing HbA1c from baseline, compared with exenatide once-weekly or dapagliflozin alone (–2.0 per cent versus –1.6 per cent and –1.4 per cent respectively, both P<0.01) at 28 weeks.
The results were presented at the European Association for the Study of Diabetes 52nd Annual Meeting (EASD) in Munich, Germany and was simultaneously published in The Lancet Diabetes Endocrinology.
The study was a phase III, randomised, multicentre, double-blind, active controlled trial.
It was conducted over a 28-week treatment period, with an extension to two years, and enrolled approximately 700 people from six countries.
Eligible participants included adult patients with type 2 diabetes who had uncontrolled HbA1c levels at baseline ranging from 8.0 per cent to 12.0 per cent.
Dr Jonathan Day, medical and healthcare affairs director at AstraZeneca UK, said: “AstraZeneca is committed to furthering the understanding of type 2 diabetes and its management, including how our portfolio of medicines can be used to achieve beneficial outcomes for patients.
“The DURATION-8 data gives an encouraging insight into the potential benefits of combining exenatide once-weekly and dapagliflozin.”
Secondary endpoints for the trial included changes in body weight and systolic blood pressure.
Those who received the combination of exenatide once-weekly and dapagliflozin versus either medicine alone experienced significantly greater body weight reduction (–3.41 kg versus –1.54 kg and –2.19 kg, respectively; both P<0.01); weight reductions seen with the combination were greater (–4.47 kg) in patients with a baseline HbA1c of 8-9 per cent versus those with a baseline greater than 9 per cent (-2.59 kg).
They also saw a significantly greater systolic blood pressure reduction (–4.2 mmHg vs –1.3 mmHg, P=0.007; and –1.8 mmHg, P=0.025).