The phase III DURATION-8 trial showed that Bydureon, taken just once a week in combination with Forxiga once daily significantly reduced blood sugar, compared with the individual medicines alone in type-2 diabetes patients inadequately controlled on metformin.
It was the first clinical trial to combine the two different anti-diabetes medicines. The study was carried out over a 28-week treatment period, with an extension to two years, and enrolled nearly 700 patients in six countries.
The combination therapy led to a 1.95% reduction in HbA1c, a measure of long-term blood glucose levels, better than the 1.58% and 1.37% reduction from using Bydureon and Forxiga on their own, respectively.
It was also demonstrated to be better in terms of the secondary endpoints that include changes in body weight and systolic blood pressure.
Diarrhoea, injection-site nodules, nausea and urinary tract infections were the most common adverse events.
AstraZeneca vice president, head of cardiovascular and metabolic diseases for global medicines development Elisabeth Björk said: “With DURATION-8, AstraZeneca is the first company to highlight the potential benefits of combining a GLP-1 receptor agonist and SGLT-2 inhibitor as a highly-effective 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.”