Bydureon (exenatide extended-release; AstraZeneca) for injectable suspension 2mg once weekly in combination with Farxiga (dapagliflozin AstraZeneca) 10mg once daily, significantly reduced HbA1c vs. individual medicines alone in patients with type 2 diabetes inadequately controlled on metformin, according to data from the Phase 3 DURATION-8 trial. Full findings from the study are published in The Lancet Diabetes & Endocrinology.
DURATION-8 was the first clinical trial to combine the 2 different antidiabetic agents (GLP-1 receptor agonist and 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 study met its primary endpoint with combination of exenatide once-weekly and dapagliflozin significantly reducing HbA1c from baseline vs. exenatide once-weekly or dapagliflozin alone (-2.0% vs. -1.6% and -1.4%, respectively; P<0.01) at 28 weeks. Secondary endpoints included changes in body weight and systolic blood pressure. Study patients who received the exenatide once-weekly and dapagliflozin vs. either exenatide once-weekly or dapagliflozin alone had significantly greater body weight reduction (-3.4kg vs. -1.5kg and -2.2kg, respectively; P<0.01) and significantly greater systolic blood pressure reduction (-4.2mmHg vs. -1.3mmHg and -1.8mmHg, respectively; P<0.05).
The rate of adverse events and serious adverse events associated with the combination of exenatide once-weekly and dapagliflozin were similar to the individual medicine treatment groups.
Bydureon, a GLP-1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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