Dulaglutide Assessed for Type 2 Diabetes With CKD
Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist.
Treatment with dulaglutide, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, was found to produce glycemic control similar to that of insulin glargine in patients with type 2 diabetes (T2D) and moderate-to-severe chronic kidney disease (CKD), and was associated with reduced decline in estimated glomerular filtration rate (eGFR). Findings from the AWARD-7 study, which assessed the safety and efficacy of dulaglutide in this patient population, were published in The Lancet Diabetes & Endocrinology.
In AWARD-7, eligible patients (N=577) were randomized to receive dulaglutide 1.5mg once-weekly (N=193), dulaglutide 0.75mg (N=190) once-weekly, or insulin glargine daily (N=194), all in combination with insulin lispro, for 52 weeks. HbA1c at 26 weeks with a 0.4% non-inferiority margin was designated as the primary outcome, while secondary outcomes included eGFR and urine albumin-to-creatinine ratio.
At 26 weeks, dulaglutide was found to be non-inferior to insulin glargine in its effects on HbA1c (least squares mean [LSM] −1.2% [SE 0.1] for dulaglutide 1.5mg (N=183); −1.1% [0.1] for dulaglutide 0.75mg (N=180); −1.1% [0.1] for insulin glargine (N=186); one-sided P≤·0001 for both dulaglutide doses vs insulin glargine.)
As measured by the Chronic Kidney Disease Epidemiology Collaboration equation, eGFR was found to be higher with both dulaglutide doses than with insulin glargine (LSM 34.0mL/min per 1.73m2 for dulaglutide 1.5mg and 33.8mL/min per 1.73m2 for dulaglutide 0.75mg vs 31.3mL/min per 1.73m2 for insulin glargine) at 52 weeks. The effects of dulaglutide 1.5mg and 0.75mg on urine albumin-to-creatinine ratio reduction were not significantly different from that of insulin glargine (LSM −22.5% [95% CI −35.1 to −7.5] with dulaglutide 1.5mg; −20.1% [–33.1 to −4.6] with dulaglutide 0.75mg; −13.0% [–27.1 to 3.9] with insulin glargine), while end-stage renal disease occurred in 4%, 7% and 8% of patients in the dulaglutide 1.5mg, 0.75mg and insulin glargine arms, respectively.
Based on the findings, the authors concluded that “dulaglutide seems to be safe to use to achieve glycemic control in patients with moderate-to-severe chronic kidney disease."