EASD 2022: Efficacy and Safety of Ultra-Rapid Lispro Compared to Insulin Lispro in Adults with Type 1 Diabetes
A novel formulation of insulin Lispro, the ultra-rapid Lispro insulin (URLi) is a faster-acting insulin with a short duration of action causing more effective postprandial glucose reduction. The abstract presented by Zhou and colleagues demonstrates the efficacy and safety of URLi versus insulin lispro among type 1 diabetes patients in a phase 3 randomised, double-blind, multinational, multicentre, parallel, active-controlled study.
The study included 354 patients who were randomised to receive URLi (n = 176) or insulin lispro (n = 178) in combination with basal insulin glargine or insulin degludec. Efficacy of URLi versus insulin lispro at 26 weeks was assessed through a mixed-effect model repeated measure (MMRM) analysis of change from baseline in HbA1c (non-inferiority margin 0.4%). URLi group demonstrated least squares mean (LSMean) reduction of HbA1c by 0.21% while that by insulin lispro group was 0.28% with a LS Mean difference (95% CI) of 0.07% (-0.11, 0.24) [0.7 mmol/mol (-1.2, 2.7)] between the two groups. As compared to insulin lispro, there was a significantly lower PPG excursions with URLi at 1-hour (4.7 mmol/L vs. 5.7 mmol/L, p=0.003) and 2-hour (6.5 mmol/L vs. 7.9 mmol/L, p=0.001). URLi group also showed significantly larger reduction of SMBG values from baseline to Week 26 morning pre-meal (-0.57 mmol/L vs. 0.31 mmol/L, p<0.001), morning 1-hour post-meal (-1.13 mmol/L vs. -0.35 mmol/L, p=0.005), and morning 2-hour post meal (-1.36 mmol/L vs. -0.53 mmol/L, p=0.004).
The study has demonstrated that URLi is non-inferior to insulin lispro for glycemic control in type 1 diabetes patients when administered as prandial insulin, in combination with basal insulin and superior to insulin lispro in controlling 1-hour and 2-hour PPG excursions.
Abstract 706. European Association for the Study of Diabetes (EASD) International Congress 2022, 19th – 23rd Sept. 2022, Stockholm
