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Aim To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro (Humalog®) in people with type 1 diabetes on continuous subcutaneous insulin infusion (CSII). Materials and Methods This was a phase 3, 16‐week, treat‐to‐target study in patients randomized to double‐blind URLi (N = 215) or lispro (N = 217). The primary endpoint was change from baseline HbA1c (non‐inferiority margin 4.4 mmol/mol [0.4%]), with multiplicity‐adjusted objectives for postprandial glucose (PPG) levels during a meal test, and time spent in the target range 70–180 mg/dL (TIR). Results URLi was non‐inferior to lispro for change in HbA1c, with a 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‐h 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 h 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

Aims To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26‐week, treat‐to‐target, phase 3 trial. Materials and methods After an 8‐week lead‐in to optimize basal insulin glargine or degludec, patients were randomized to double‐blind mealtime URLi (n = 451) or lispro (n = 442), or open‐label post‐meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non‐inferiority margin 0.4%), with multiplicity‐adjusted objectives for postprandial glucose (PPG) excursions after a meal test. Results Both mealtime and post‐meal URLi demonstrated non‐inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi −0.08% [95% confidence interval (CI) −0.16, 0.00] and for post‐meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post‐meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1‐ and 2‐hour PPG excursions during the meal test: ETD −1.55 mmol/L (95% CI −1.96, −1.14) at 1 hour and − 1.73 mmol/L (95% CI −2.28, −1.18) at 2 hours (both P 4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post‐meal URLi, and 0.2% on lispro. Overall, the incidence of treatment‐emergent adverse events was similar between treatments. Conclusions The results showed that URLi provided good glycaemic control, with non‐inferiority to lispro confirmed for both mealtime and post‐meal URLi, while superior PPG control was demonstrated with mealtime dosing.