AstraZeneca Diabetes Drug Combination Positive In Phase III
Zacks Investment Research | Sep 18, 2016 10:28PM ET
AstraZeneca plc (NYSE:AZN) announced positive results from a phase III combination trial evaluating the combination of its diabetes drugs Bydureon (exenatide extended-release) and Farxiga (dapagliflozin) for the treatment of patients with type II diabetes.
Anti-diabetes medicine Bydureon is a GLP-1 receptor agonist, whereas Farxiga is an SGLT-2 inhibitor.
The study achieved the primary endpoint, showing significant blood sugar reduction from baseline (as measured by HbA1c) in patients with type II diabetes, when treated with the combination of once-weekly exenatide and dapagliflozin, compared with the drugs alone in patients, who are inadequately controlled on metformin.
Duration-8 is a phase III, randomized, multi-center, double-blind, active-controlled trial. It was conducted over a 28-week treatment period, with an extension of two years, and enrolled approximately 700 patients from six countries. Eligible participants in the trial included adults with type II diabetes, who had uncontrolled HbA1c. The trial achieved the secondary endpoints as well, leading to a significant reduction in bodyweight and systolic blood pressure for the combination drug.
The combination of exenatide and dapagliflozin demonstrated similar rates of adverse events and serious events as the individual medicine treatment groups.
The results were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes in Munich, Germany, and were also published in The Lancet Diabetes & Endocrinology.
AstraZeneca has been making significant progress with its pipeline. Promising pipeline candidates at the company include brodalumab (moderate-to-severe psoriasis), benralizumab (asthma and chronic obstructive pulmonary disease), tralokinumab (asthma), anifrolumab (systemic lupus erythematosus), roxadustat (anemia in patients with chronic kidney disease) and AZD3293 (Alzheimer’s disease, phase III).
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