150-OR: BioChaperone Pramlintide Insulin (BCPramIns), a New Co-Formulation of Pramlintide (PRAM) and Human Insulin (INS), Improves Postprandial Blood Glucose (BG) vs. Both Separate Injections of PRAM+INS and Insulin Lispro (LIS) in Subjects with T1D

Abstract

BCPramIns is developed to leverage the beneficial effects of PRAM on post-prandial BG control in a convenient co-formulation with INS. This double-blind, randomized cross-over study investigated pharmacodynamics, pharmacokinetics and safety of BCPramIns in 24 subjects with T1DM [mean±SD age 41±10 years; BMI 25±2.3 kg/m²; HbA1c 7.2±0.6%] who received fixed doses of 7.5 IU INS and 45 µg PRAM either as a single injection of BCPramIns or separate injections (PRAM+INS) before a mixed meal tolerance test in comparison to 7.5 U insulin lispro (LIS) with BCPramIns, BG excursions in the first 2 hours post-meal were reduced by 97% (p<0.0001) and 82% (NS) compared to LIS and PRAM+INS, respectively (Table). Time to maximum BG was prolonged by BCPramIns compared to LIS and slightly delayed compared to PRAM+INS, (5.00h vs. 3.00h and 4.25h respectively, Table). Insulin exposure was similar between BCPramIns and PRAM+INS (AUCINS_0-6h 87 vs. 86 mU*h/L), indicating no impairment in insulin absorption with BCPramIns. Six adverse events occurred with BCPramIns, 4 with PRAM+INS and 3 with LIS. Hypoglycemia during dosing visit days were balanced between the three treatment groups (4-3-3). In conclusion, BCPramIns was well tolerated and improved postprandial BG versus LIS. Disclosure G. Meiffren: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. C. Seroussi: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. A. Ranson: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. R. Charvet: None. M. Gaudier: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. G. Andersen: None. E. Zijlstra: Speaker's Bureau; Self; Novo Nordisk A/S. J. DeVries: Advisory Panel; Self; Novo Nordisk A/S. Employee; Self; Profil Institute for Metabolic Research. Research Support; Self; Medtronic. Speaker's Bureau; Self; Novo Nordisk A/S. T. Heise: Advisory Panel; Self; Mylan. Research Support; Self; ADOCIA, Boehringer Ingelheim International GmbH, Dance Biopharm Holdings Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Johnson & Johnson, MedImmune, Mylan, Nordic Bioscience, Novo Nordisk A/S, Pfizer Inc., Poxel, Saniona, Sanofi, Wockhardt, Zealand Pharma A/S. Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. R. Soula: Board Member; Self; Cellnovo. Employee; Self; ADOCIA. O. Soula: Board Member; Self; ADOCIA. Employee; Spouse/Partner; ADOCIA. Employee; Self; ADOCIA. Stock/Shareholder; Spouse/Partner; ADOCIA. Stock/Shareholder; Self; ADOCIA.