Ultra-rapid BioChaperone Lispro ameliorates postprandial blood glucose (PPBG) in a group with diabetes mellitus

Research Question:

BioChaperone Lispro (BCLIS) is an ultra-rapid insulin lispro (LIS) formulation designed to better mimic the physiological timing of prandial insulin action. The primary objective of this study was to compare the PPBG after administration of BCLIS and LIS in subjects with type 1 diabetes.

Methodology:

In this double-blind cross-over study, 38 subjects with type 1 diabetes (mean ± SD duration: 23 ± 9yrs; age: 44 ± 13yrs; BMI: 25 ± 2 kg/m²; HbA1c: 7.4 ± 0.9%) received a single subcutaneous dose (0.2 U/kg) of BCLIS or LIS at the start of a standardized liquid meal ingestion (600 kcal; 80 g carbohydrates; 25 g proteins; 20 g fat). Pre-meal BG was controlled at 100 mg/dL.

Findings:

Compared to LIS, BCLIS exhibited a statistically significant higher early insulin exposure post-dosing (Least square means ratio [95% CI] AUC_{0 – 30 min}: 2.68 [2.18; 3.30]; AUC_{0 – 1h}: 1.52 [1.37; 1.68]), a lower late exposure (AUC_{2 – 8h}: 0.79 [0.72; 0.87]) and earlier time to early and late 50% T_max (T_{0.5 max early}: 0.63 [0.57; 0.71]; T_{0.5 max late}= 0.85 [0.79; 0.91]) and T_max (0.75 [0.69; 0.83]). Compared to LIS, BCLIS significantly reduced the mean PPBG value 1h (BG_1h) and 2h (BG_2h) by 42 and 27 mg/dL, respectively and also decreased the incremental AUC_BG over the 2 first hours (ΔAUC_{BG 0 – 2h}) by 61%, thus significantly controlling PPBG. The number of hypoglycemic events after each medication was similar and there were no safety or local tolerance issue.

Conclusion:

In conclusion, ultra-rapid BCLIS is more rapidly absorbed and improves PPBG control in comparison to LIS.