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.


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.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.