673-P: Effect of Once-Weekly Dulaglutide 3.0 and 4.5 mg in Patients with Different Baseline Renal Function: Post-hoc Analysis from the Award-11 Trial

Abstract

Background: AWARD-11 study in patients with type 2 diabetes on metformin demonstrated similar safety and superior efficacy of dulaglutide (DU) 3.0 and 4.5 mg vs. DU 1.5 mg. A post hoc analysis assessed consistency in safety and efficacy of the three DU doses across patients with different baseline renal function (RF) levels. Methods: Participants randomized to DU 1.5, 3.0, and 4.5 mg were categorized into three RF levels based on baseline estimated glomerular filtration rate (eGFR; eGFR≥90, eGFR 60-90, and eGFR 30-60; eGFR unit: ml/min/1.73m2). Key safety and efficacy parameters were explored at week 52. Results: There was no evidence of inconsistency in the effect of DU treatment across patients in any RF subgroup for incidence of gastrointestinal events, hypoglycemia, new onset albuminuria or macroalbuminuria, or change from baseline in heart rate, blood pressure, or PR interval (interaction p-value >0.05 for all). There was no evidence of inconsistency in the effect of DU treatment patients in any RF subgroups for change from baseline in HbA1c (interaction p-value=0.128) and bodyweight values (interaction p-value=0.607). Conclusions: Effect of DU treatment was associated with consistent safety and efficacy patterns for all patients regardless of their RF status at baseline. Disclosure L. Garcia-perez: Employee; Self; Eli Lilly and Company. J. M. Maldonado: Employee; Self; Eli Lilly and Company. K. T. Ranta: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. S. Raha: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company