197-OR: ADO09, a Coformulation of Insulin A21G and Pramlintide (Pram), Improves Blood Glucose Control and Reduces Body Weight in Subjects with T1D

Abstract

ADO09 is a co-formulation of Pram and insulin A21G developed to deliver the positive effects of Pram without additional injections. This double-blind randomized cross-over trial investigated the effects of pre-meal ADO09 vs. insulin aspart (ASP) on mixed meal tolerance tests (MMTT) and CGM over 24 days in 16 T1D subjects (BMI 30.5 ± 3.1 kg/m²) using daily prandial insulin doses of 45-75 U. ADO09 reduced incremental AUC glucose 0-4h during MMTT by 69% (p=0.006) and deltaPG 1h by 82 mg/dL (p<0.001) vs. ASP (figure). Post-meal glucagon levels were lowered by up to 85% and speed of gastric emptying (acetaminophen absorption) reduced by >50% with ADO09. CGM over the final 3 weeks showed higher time in range (+58 min), lower time >180 mg/dL (-71 min) and slightly higher time <70 mg/dL (+13mins) with ADO09. Body weight decreased by 1.6 kg with ADO09 (p=0.007) as did daily prandial insulin doses (-12 U vs. ASP, median 35.0 U vs. 47.3; p=0.0004). Slightly more hypoglycemic episodes were noted with ADO09 (n=96 vs. 79) with no difference in nocturnal hypoglycemia. While more adverse events (AEs) occurred with ADO09 (22 vs. 10), most AEs were mild and of gastro-intestinal nature (nausea, decreased appetite).In conclusion, ADO09 improved blood glucose control and reduced both body weight and prandial insulin doses vs. insulin aspart in T1D subjects with high prandial insulin needs.View largeDownload slideView largeDownload slide DisclosureG. Meiffren: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. J. Devries: Advisory Panel; Self; ADOCIA, Novo Nordisk Inc., Zealand Pharma A/S, Speaker’s Bureau; Self; Novo Nordisk Inc. T. Heise: Advisory Panel; Self; Novo Nordisk A/S, Valbiotis, Research Support; Self; ADOCIA, Afon Technology Ltd., AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Gan & Lee Pharmaceuticals, Johnson & Johnson, Julphar, Mylan N. V., Nestlé, Neuraly, Nordic Bioscience, Novo Nordisk, Sanofi, Zealand Pharma A/S, Speaker’s Bureau; Self; Novo Nordisk A/S. G. Andersen: None. R. Eloy: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. C. Mégret: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. S. Famulla: None. C. Seroussi: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. Y. Chan: Employee; Self; ADOCIA. M. Gaudier: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. O. Soula: Employee; Self; ADOCIA, Employee; Spouse/Partner; ADOCIA, Stock/Shareholder; Self; ADOCIA, Stock/Shareholder; Spouse/Partner; ADOCIA.