Common Diabetes Drug Is Safe With SGLT-2 Inhibitors
Dulaglutide is safe and effective as an add-on treatment to sodium-glucose co-transporter-2 (SGLT2) inhibitors in patients with type 2 diabetes, according to new findings.
Researchers arrived at this conclusion following the AWARD-10 study, which included 424 adult patients with inadequately controlled type 2 diabetes—defined as a hemoglobin A1c (HbA1c) concentration of at least 7.0%.
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All participants included in the study also had a body mass index of 45 kg/m2 or less and were treated with stable doses of an SGLT2 inhibitor with or without metformin.
Each participant was randomly assigned to treatment with once-weekly subcutaneous injections of 1.5 mg dulaglutide (n = 142), 0.75 mg dulaglutide (n = 142), or placebo (n = 140) for 24 weeks.
Results indicated that patients treated with 1.5 mg or 0.75 mg dulaglutide demonstrated larger reductions in in HbA1c concentration at 24 weeks than those who received placebo (least square means [LSMs] -1.34%, -1.21%, and -0.54%, respectively).
Serious adverse events occurred in 5 patients treated with 1.5 mg dulaglutide, 3 patients who received 0.75 mg dulaglutide, and 5 patients who received placebo. The researchers noted that treatment-emergent adverse events were more commonly observed in patients who received dulaglutide than in those who received placebo, largely due to an increased incidence of gastrointestinal events.
Two patients in the 1.5-mg dulaglutide group died, but these deaths were not considered related to the study drug.
“Dulaglutide as add-on treatment to SGLT2 inhibitors (with or without metformin) resulted in significant and clinically relevant improvements in glycemic control, with acceptable tolerability that is consistent with the established safety profile of dulaglutide,” the researchers concluded.
—Christina Vogt
Reference:
Ludvik B, Frías JP, Tinahones FJ, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomized, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018;6(5):370-381. https://doi.org/10.1016/S2213-8587(18)30023-8