Ultra‐rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double‐blind phase 3 study

Abstract

AbstractAimsTo investigate the efficacy and safety of ultra‐rapid lispro (URLi) versus insulin lispro in predominantly Chinese patients with type 1 diabetes (T1D) in a prospective, randomized, double‐blind, treat‐to‐target, phase 3 study.Materials and MethodsFollowing a lead‐in period, during which insulin glargine U‐100 or insulin degludec U‐100 was optimized, patients were randomly assigned (1:1) to URLi (n = 176) or insulin lispro (n = 178). The primary objective was to test the noninferiority of URLi to insulin lispro in glycaemic control (noninferiority margin = 0.4% for glycated haemoglobin [HbA1c] change from baseline to week 26), with testing for the superiority of URLi to insulin lispro with regard to 1‐ and 2‐hour postprandial glucose (PPG) excursions during a mixed‐meal tolerance test and HbA1c change at week 26 as the multiplicity‐adjusted objectives.ResultsFrom baseline to week 26, HbA1c decreased by 0.21% and 0.28% with URLi and insulin lispro, respectively, with a least squares mean treatment difference of 0.07% (95% confidence interval −0.11 to 0.24; P = 0.467). URLi demonstrated smaller 1‐ and 2‐hour PPG excursions at week 26 with least squares mean treatment differences of −1.0 mmol/L (−17.8 mg/dL) and −1.4 mmol/L (−25.5 mg/dL), respectively (p < 0.005 for both) versus insulin lispro. The safety profiles of URLi and insulin lispro were similar.ConclusionsIn this study, URLi administered in a basal‐bolus regimen demonstrated superiority to insulin lispro in controlling PPG excursions, with noninferiority of HbA1c control in predominantly Chinese patients with T1D.