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Combined Bydureon, Farxiga More Effective Than Monotherapy for Type 2 Diabetes
According recent research in The Lancet Diabetes & Endocrinology, Bydureon (exenatide extended- release; AstraZeneca) and Farxiga (dapagliflozin; AstraZeneca) combination treatment therapy improved various glycemic measures and cardiovascular risk factors among patients with type 2 diabetes inadequately controlled by metformin monotherapy.
“Because of the progressive nature of type 2 diabetes, patients often require multiple anti-diabetic medicines to achieve and maintain glycemic control,” Serge A Jabbour, MD, FACP, FACE, professor of medicine in the division of endocrinology at the Sidney Kimmel Medical College at Thomas Jefferson University, said in a press release. “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.”
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The research was conducted as part of the DURATION-8 trials, a 28-week, multicenter, double-blind, randomized, active-controlled phase III trial. The researchers investigated 109 sites in six countries. Study participants included 695 adults aged 18 years and older with type 2 diabetes and inadequate glycemic control despite stable metformin monotherapy (≥1500 mg/day). Patients received once-weekly exenatide (2 mg by subcutaneous injection) along with once-daily dapagliflozin (10 mg oral tablets). Patients were randomly received exenatide plus dapagliflozin (n=231), exenatide alone (n=231; n=1 untreated), or dapagliflozin alone (n=233). The primary endpoint was a change in HbA1c from the baseline to week 28. Secondary endpoints included:
- change from baseline in fasting plasma glucose at week 2 and week 28, and 2 h postprandial glucose at week 28;
- the proportion of patients with an HbA1c less than 7·0% (<53 mmol/mol) at week 28;
- change in weight at week 28;
- the proportion of patients with weight loss of 5% or more at week 28; and,
- change in systolic blood pressure at week 28.
According to the study results, After 28 weeks, the change in baseline HbA1c was -2·0% in the exenatide plus dapagliflozin group, -1·6% in the exenatide group, and -1·4% in the dapagliflozin group. Exenatide plus dapagliflozin significantly reduced HbA1c from baseline to week 28 compared with exenatide alone (P = .004) or dapagliflozin alone (P < .001). Furthermore, exenatide plus dapagliflozin was superior to either drug given alone for all secondary end points.
Adverse events were recorded in 131 of 231 patients (57%) in the exenatide plus dapagliflozin group, 124 of 230 patients (54%) in the exenatide group, and 121 of 233 patients (52%) in the dapagliflozin group. The most common adverse events were diarrhea, injection-site nodules, nausea, and urinary tract infections.
“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,” Elisabeth Björk, MD, PhD, vice president, head of cardiovascular and metabolic diseases in global medicines development at AstraZeneca, said in a press release. —Julie Gould
References:
Frias JP, Guja C, Hardy E, et al. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial [published online September 2016] The Lancet Diabetes & Endocrinology. DOI: https://dx.doi.org/10.1016/S2213-8587(16)30267-4
