112-LB: ADO09, a Coformulation of Pramlintide (PRAM) and Insulin A21G, Improves Postprandial Glucose vs. Novolog in Type 1 Diabetes (T1D)

ADO09 is a co-formulation of PRAM and insulin A21G developed to leverage the beneficial effects of PRAM on post-prandial glucose without additional injections. This double-blind randomized cross-over trial studied pre-meal ADO09 vs. Novolog® over 24 days with degludec as basal insulin. Mixed meal tolerance test data (MMTTs) and CGM metrics of 21 T1D subjects were analyzed. Incremental plasma glucose MMTT-AUCs with ADO09 on day 24 were reduced by >100% after 1h and 2h (both p<0.001) and by 39% after 4h (not significant) vs. Novolog. Similarly, ∆PGmax was reduced by 19 mg/dL (p=0.01) and ∆PG_1h by 70 mg/dL (p<0.001)(Fig. 1). ADO09 showed improved CGM-metrics with higher 24h-time in range (TIR 70-180 mg/dL, + 51 min, p=0.01), time in tight range (80-140mg/dL, +70 min, p=0.002). Time <70 mg/dL was slightly higher (+9.6 min, p=0.046) as were hypoglycemic events (142 vs. 115) in the outpatient period. ADO09 significantly reduced body weight (-0.7kg vs. baseline, p=0.01). On the last outpatient day, mean daily bolus doses were 4 U lower with ADO09 (-21%, p=0.05). Both treatments were well tolerated with more gastrointestinal adverse events (24 vs. 6) observed with ADO09, consistent with typical effect of PRAM. In conclusion, ADO09 significantly improved CGM metrics including TIR, weight control and bolus insulin needs vs. Novolog over 24 days of use. Disclosure G. Meiffren: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. G. Andersen: Employee; Self; Profil Institute for Clinical Research. R. Eloy: Employee; Self; ADOCIA. C. Seroussi: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. C. Mégret: None. S. Famulla: None. Y. Chan: Employee; Self; ADOCIA. M. Gaudier: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. O. Soula: Board Member; Self; ADOCIA. Employee; Self; ADOCIA. Employee; Spouse/Partner; ADOCIA. Stock/Shareholder; Spouse/Partner; ADOCIA. Stock/Shareholder; Self; ADOCIA. J. DeVries: Advisory Panel; Self; Novo Nordisk A/S, Zealand Pharma A/S. Consultant; Self; Metronom Health. Employee; Self; Profil Institute for Clinical Research. T. Heise: Advisory Panel; Self; Mylan, Novo Nordisk A/S. Research Support; Self; ADOCIA, Aerami, Becton, Dickinson and Company, Biocon, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Gan & Lee Pharmaceuticals, MedImmune, Merck KGaA, Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Sanofi, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S.