BC Combo is a co-formulation of prandial insulin lispro (25%) and basal insulin glargine (75%) with a rapid “prandial“ insulin component and prolonged flat “basal“ component compared to LMx. In this study the effects of BC Combo on PPG vs. LMx and G+L were investigated. Thirty-nine T2DM subjects (mean±SD age 60.8±7.5 years and HbA1c 7.97±0.6%) were randomized to receive the three insulin combinations immediately before a standardized solid meal test (MMT, 20% protein 30% fat 50% carbohydrates) in a double-blind, double-dummy, cross-over design. The individual insulin dose was the same for each visit day (mean 0.62 U/kg). BC Combo demonstrated improved PPG compared to LMx (Figure, reduction ∆AUCBG,0-2h of 18%, p=0.0009) and G+L (reduction ∆AUCBG,0-2h of 10%, p=0.0450). The proportion of subjects experiencing documented symptomatic hypoglycemic events (plasma glucose <70 mg/mL) over 24h was numerically lower with BC Combo (15.8%) vs. LMx (32.4%) and G+L (21.6%). The total insulin PK profile of BC Combo showed a faster time to insulin peak and a lower exposure in the late prandial phase (2-6 h) than LMx and G+L.
In conclusion, BC Combo demonstrated superior PPG control in T2DM subjects with numerically fewer subjects experiencing symptomatic hypoglycemia compared to both LMx and separate G+L.
T. Heise: Research Support; Self; ADOCIA, Boehringer Ingelheim GmbH, Dance Biopharm, Eli Lilly and Company, Janssen Research & Development, MedImmune, Merck Sharp & Dohme Corp., Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Roche Diagnostics Corporation, Saniona, Sanofi, Senseonics, Zealand Pharma A/S. Advisory Panel; Self; Novo Nordisk A/S, Mylan. Speaker's Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk A/S, Sanofi. L. Plum-Moerschel: None. C. Mégret: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. T. Herbrand: None. V. Vacher: Employee; Self; ADOCIA. E. Anastassiadis: None. O. Klein: None. M. Gaudier: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. O. Soula: Board Member; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. Employee; Spouse/Partner; ADOCIA. S. Glezer: Stock/Shareholder; Self; Sanofi. Stock/Shareholder; Spouse/Partner; Sanofi. Employee; Self; ADOCIA, Novo Nordisk Inc.. Employee; Spouse/Partner; Pfizer Inc., Teva Pharmaceutical Industries Ltd.. Stock/Shareholder; Spouse/Partner; Teva Pharmaceutical Industries Ltd.. B. Alluis: None. G. Meiffren: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA.