Once-weekly dulaglutide may safely and effectively replace insulin glargine in patients with type 2 diabetes and moderate to severe chronic kidney disease, according to a study published in The Lancet Diabetes and Endocrinology.
For patients with diabetes and kidney disease, treatment options for hyperglycemia are limited. Thus, researchers sought to determine the efficacy and safety of dulaglutide, a long-acting, glucagon-like peptide-1 receptor agonist that does not require renal clearance.
In this 52-week, multicenter, open-label trial, 577 patients with type 2 diabetes and moderate to severe chronic kidney disease were randomly assigned to receive — in combination with insulin lispro — once-weekly injectable dulaglutide 1.5 mg (n=193), once-weekly dulaglutide 0.75 mg (n=190), or daily insulin glargine (n=194).
The primary outcome was change in glycated hemoglobin (HbA1c) from baseline to week 26 with a noninferiority margin of 0.4%. Secondary outcomes include change in estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, body weight, and rates of hypoglycemia and allergic reactions.
In regard to HbA1c decrease, at 26 and 52 weeks both dulaglutide doses were found to be noninferior to insulin glargine. The researchers also determined that compared with insulin glargine, dulaglutide treatment was associated with weight loss, a lower rate of hypoglycemia, a smaller decline in estimated glomerular filtration rate, and a greater reduction in albuminuria.
Additionally, on the basis of an approximately 50% lower rate of hypoglycemia with dulaglutide and similar rates of adverse events with the 2 drugs, the researchers concluded that dulaglutide has a clear safety advantage over insulin glargine.
Limitations to this study included a short treatment duration as well as an open-label design, which was deemed necessary owing to dose adjustment requirements in the insulin glargine group.
Despite these and other limitations, the researchers said their results demonstrate “that onceweekly dulaglutide treatment has similar glycemic efficacy to daily insulin glargine treatment.” In addition, they stated, “Dulaglutide treatment showed an overall favorable safety profile along with possible therapeutic benefits.”
Tuttle KR, Lakshmanan MC, Rayner B, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial [published online June 14, 2018]. Lancet Diabetes Endocrinol. doi: 10.1016/S2213-8587(18)30104-9