Background and aims Ultra Rapid Lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion.
Materials and methods This 2-site, randomised, 2-period crossover, double-blind study evaluated the pharmacokinetics and glucodynamics during a liquid test meal, after a single 0.2 U / kg SC dose of URLi or Lispro in 13 children, 14 adolescents, 15 adults with Type 1 Diabetes (T1D).
Results Onset of insulin appearance was faster with URLi vs Lispro in children (1.1 vs 6.5 min; p= 0.0002), adolescents (1.9 vs 6.4 min; p = 0.001), and adults (0.9 vs 4.8 min; p = 0.004). Early exposure (AUC0-15min) was greater with URLi vs Lispro: 7-fold (p< 0.0001) in children, 4 fold (p = 0.0003) in adolescents, 5-fold (p < 0.0001) in adults; late exposure (AUC3-7h) was reduced by 58 % (p< 0.0001) in children, 40 % (p = 0.013) in adolescents, 37 % (p = 0.021) in adults. Total exposure was similar in URLi and Lispro. At 1 hour vs Lispro, URLi reduced PPG by 2.3 mmol / L (p = 0.008) in children, 1.1 mmol / L (p = 0.195) in adolescents, 1.9 mmol / L (p = 0.018) in adults. At 2 hours vs Lispro, URLi reduced the PPG by 1.8 mmol / L (p = 0.11) in children, 2.2 mmol / L (p = 0.051) in adolescents and was not statistically different in adults. URLi was well tolerated in all age groups.
Conclusion In summary, URLi accelerated insulin lispro absorption, reduced late exposure and early PPG following a test meal vs Lispro in children, adolescents, and adults with T1 D.
