Phase III combination trial of Bydureon and Farxiga shows significant blood sugar reduction in patients with type 2 diabetes

This was the first clinical trial to combine these two different anti-diabetes medicines, a GLP-1 receptor agonist and an SGLT-2 inhibitor, as an addition to standard-of-care therapy to evaluate potential benefits for patients with type 2 diabetes with inadequate glycemic control.

This was the first clinical trial to combine these two different anti-diabetes medicines, a GLP-1 receptor agonist and an SGLT-2 inhibitor, as an addition to standard-of-care therapy to evaluate potential benefits for patients with type 2 diabetes with inadequate glycemic control. The results were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany, and simultaneously published in The Lancet Diabetes & Endocrinology.

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, at 28 weeks.

Serge A. Jabbour, Professor of Medicine, Director of the Division of Endocrinology and Director of the Diabetes Center at the Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, said: “Because of the progressive nature of type 2 diabetes, patients often require multiple anti-diabetic medicines to achieve and maintain glycemic control. The results of DURATION-8 show that combining medicines that work in different ways can significantly reduce HbA1c, as well as weight and systolic blood pressure.”

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca, said: “With DURATION-8, AstraZeneca is the first company to highlight the results of combining a GLP-1 receptor agonist and SGLT-2 inhibitor as a potential treatment alternative to existing non-insulin therapies for patients with severe, uncontrolled type 2 diabetes. Further, it reinforces our commitment to pushing the boundaries of science in the treatment of a disease that affects an estimated 415 million adults worldwide.”

Secondary endpoints for the trial included changes in body weight and systolic blood pressure. Patients receiving the combination of exenatide once-weekly and dapagliflozin versus either exenatide once-weekly or dapagliflozin alone experienced

This combination of products is not FDA approved, and neither product is approved for weight loss or the treatment of hypertension.