To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in persons with type 1 diabetes on continuous subcutaneous insulin infusion (CSII).
This was a phase 3, 16-week, treat-to-target study in patients randomised to double-blind URLi (N=215) or lispro (N=217). Primary endpoint was change from baseline HbA1c (noninferiority margin 4.4 mmol/mol [0.4%]), with multiplicity-adjusted objectives for postprandial glucose (PPG) levels during a meal test, and time spent in target range 70-180 mg/dL (TIR).
URLi was noninferior to lispro for change in HbA1c, with least squares mean (LSM) difference of 0.3 mmol/mol (95% confidence interval [CI] -0.6, 1.2) or 0.02% (95% CI -0.06, 0.11). URLi was superior to lispro in controlling 1- and 2-hour PPG levels after the meal test: LSM difference -1.34 mmol/L (95% CI -2.00, -0.68) or -24.1 mg/dL (95% CI -36.0, -12.2) at 1-hour and -1.54 mmol/L (95% CI -2.37, -0.72) or -27.8 mg/dL(95% CI -42.6, -13.0) at 2-h; both p<0.001. TIR and time in hyperglycaemia were similar between groups but URLi resulted in significantly less time in hypoglycaemia (3.0 mmol/L [<54 mg/dL]) over the daytime, nighttime, and 24-hour period: LSM difference -0.41%, -0.97%, and -0.52% respectively, all p<0.05. The incidence of treatment-emergent adverse events was higher with URLi (60.5% vs. 44.7%), driven by infusion site reaction and infusion site pain which were mostly mild or moderate. Rates of severe hypoglycaemia and diabetic ketoacidosis were similar between groups.
URLi was efficacious, providing superior PPG control and less time in hypoglycaemia but with more frequent infusion site reactions compared to lispro when administered by CSII. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.