806-P: Once Weekly (QW) Basal Insulin Fc (BIF) and Daily Degludec (DEG) Achieve Comparable Glycemic Control in Three Patient Populations Studied during Phase 2—Clinical Insights from CGM Assessments

Abstract

BIF is a fusion protein combining a novel single chain insulin variant with a human IgG Fc domain. Three randomized, open-label, treat-to-target phase 2 studies of 26 or 32 week duration assessed 912 people with T2D previously treated with basal insulin (T2D-Switch) or new to insulin therapy (T2D-Naïve), or T1D on multiple daily injections (T1D). Studies assessed QW BIF vs once daily DEG. Key results were previously disclosed and met the primary endpoint of non-inferiority in HbA1c change from baseline (non-inferiority margin=0.4%). Two studies had CGM during entire study and T2D-Naïve had blinded, intermittent CGM using 14-day sessions. Patients had baseline HbA1c of 8.1, 8.0, and 7.5% for T2D-Switch, T2D-Naïve, and T1D respectively. Figure shows average hourly mean glucose at endpoint and time in range (inset). Glucose profiles appeared comparable between treatments with 24-hour average glucose for BIF vs DEG in T2D-Naïve: 137 vs 127 mg/dL p=.042 and T1D: 175 vs 169 p=.075 (T2D-Switch not available). Average duration of hypoglycemia, <70mg/dL (min) per patient for BIF vs DEG: T2D-Switch 31 vs 35 p=NS, T2D-Naïve 51 vs 91 p<.001, and T1D 35 vs 35 p=NS. QW BIF achieved similar glycemic control vs DEG as seen in several CGM derived measures providing useful and reassuring insights into the use of QW BIF in these patient populations. Disclosure C.M.Kazda: Employee; Eli Lilly and Company. J.M.Bue-valleskey: Employee; Eli Lilly and Company. Q.Zhang: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A.Haupt: Employee; Lilly, Stock/Shareholder; Lilly. J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. D.Dahl: Research Support; Lilly, Novo Nordisk, Eli Lilly and Company, Boehringer Ingelheim Inc., Amgen Inc. Funding Eli Lilly and Company