Better Postprandial Glucose (PPG) Control with BioChaperone Combo (BC Combo) than with Lispro Mix25 (LMx) or Separate Glargine and Lispro (G+L) Administrations in Subjects with Type 2 Diabetes (T2DM)

Abstract

Pharmacokinetics oBC Combo showed an earlier onset of appearance (Early t 0.5max ) and higher early PK exposure in the first hour compared with LMx and G+L ( Fig. 1a & Table 2).o BC Combo reached similar maximum concentrations but significantly earlier than both LMx and G+L. AbstractBC 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 LisproMix (LMx). In this study the effects of BC Combo on PPG vs. LMx and Glargine + Lantus (G+L) were investigated. Thirty-nine T2DM subjects (mean ± SD age 60.8 ± 7.5 years and HbA1c 8.0 ± 0.6 %) received the three insulin combinations immediately before a standardised solid meal test (MMT, 20% protein 30% fat 50% carbohydrates) in a double-blind, double-dummy, randomised crossover design. The individual insulin dose was the same for each visit day (mean 0.62 U/kg). BC Combo improved early PPG compared to LMx (reduction ∆AUC BG_0-2h of 18%, p=0.0009) and G+L (reduction ∆AUC BG_0-2h of 10%, p=0.0450) (primary endpoint). The proportion of subjects experiencing symptomatic hypoglycaemic events (plasma glucose <70 mg/mL) over 24h was 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 fewer subjects experiencing symptomatic hypoglycaemia compared to both LMx and separate G+L.