medwireNews: Once-weekly dulaglutide lowers glycated hemoglobin (HbA1c) levels to a similar degree to titrated daily insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (CKD), study findings indicate.
The AWARD-7 trial, conducted by Katherine Tuttle (University of Washington, Spokane, USA) and colleagues, also showed that dulaglutide treatment was associated with a smaller decline in estimated glomerular filtration rate (eGFR), a lower rate of hypoglycemia, and weight loss rather than weight gain compared with insulin glargine.
“Dulaglutide seems to be safe to use to achieve glycaemic control in patients with moderate-to-severe chronic kidney disease,” the authors write in The Lancet Diabetes & Endocrinology.
For the trial, individuals with insulin-dependent type 2 diabetes and stage 3–4 CKD were randomly assigned to receive once-weekly injectable dulaglutide at a dose of 1.5 mg (n=193) or 0.75 mg (n=190), or to daily insulin glargine (n=194) as basal therapy, each in combination with insulin lispro, for 52 weeks. Insulin glargine and lispro doses were titrated as per an adjustment algorithm.
At 26 weeks, mean HbA1c had fallen by a significant 1.2% with dulaglutide 1.5 mg, 1.1% with dulaglutide 0.75 mg, and 1.1% with insulin glargine. Using a margin of 0.4%, the researchers showed that the decrease with each dulaglutide dose was non-inferior to that with insulin glargine, with similar results observed at 52 weeks.
The team also found that while eGFR fell significantly over time among the patients receiving insulin glargine, there was no such decrease among those receiving either dose of dulaglutide.
All participants experienced significant reductions in urine albumin-to-creatinine ratio (UACR) at 26 weeks compared with baseline, with no significant differences observed between the treatment groups overall.
However, among patients with baseline macroalbuminuria, the decrease in UACR was significantly larger in the patients who received dulaglutide 1.5 mg compared with those who received insulin glargine.
Both doses of dulaglutide also led to significant weight loss (approximately 2–3 kg vs a 1.5 kg gain with insulin glargine), as well as a reduced rate of hypoglycemia compared with insulin glargine (4.3–4.4 events per patient per year with dulaglutide vs 9·6 with insulin glargine).
In an accompanying comment, David Cherney (University of Toronto, Ontario, Canada) and co-authors say: “AWARD-7 contributes new, clinically meaningful data about glucose-lowering in patients with chronic kidney disease, along with possible renal protective effects, as reflected by the [eGFR] and albuminuria findings.”
They add: “Although the absolute magnitude of eGFR preservation—approximately 1–2 ml/min per 1.73 m2—might seem small, when amortised over many years, this effect is likely to be of substantial clinical importance, especially in patients with albuminuria.”
By Laura Cowen
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