Ambulatory glucose profiles were evaluated in 269 (22%) patients (pts) in PRONTO-T1D assigned to double-blind URLi (n=97) or lispro (n=99) given at start of the meal, or open-label URLi (n=73) given 20 min after the meal (URLi +20). Primary endpoint was incremental AUC0-2h (iAUC) after breakfast. Blinded CGM (Dexcom G4 Platinum) was worn for 14 days before baseline and week 26. Pts reflected main study population: mean A1C at week 26 was 7.15% - URLi, 7.12% - lispro, 7.35% - URLi+20.
Compared to lispro, URLi had significantly smaller breakfast iAUC0-2h with estimated treatment difference (ETD) -28.1 mg.h/dL, p=0.048; more daytime TIR (71-180 mg/dL) ETD +43.6 min, p=0.020; and similar nighttime TIR. Time <50 mg/dL and >180 mg/dL were both numerically lower with URLi in daytime, with less time <50 mg/dL at nighttime vs. lispro: 7.0 vs. 12.6 min, p=0.023.
PPG control in pts who marked meal times improved with URLi, while URLi +20 showed greater PPG variability (Figure). Glucose variability via CV and SD metrics was similar between groups, but less glucose variability was noticeable in CGM profiles of pts treated with URLi.
When injected at the start of the meal, URLi resulted in significantly better PPG control and increased daytime TIR vs. lispro without increasing time in hypoglycemia. CGM results augment findings from PRONTO-T1D.
B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. D. Cao: Employee; Self; Eli Lilly and Company. R. Liu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. T. Hardy: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company.
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