Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump

Background:SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro(U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products has been demonstrated in a hyperinsulinemic euglycemic clamp study. The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps).Methods:This was a randomized, open-label, 2 × 4-week, two-arm crossover studyin 27 patients with type 1 diabetes mellitus (NCT02603510). The main outcome was the incidence of infusion set occlusions (ISOs), defined as failure to correct hyperglycemia (plasma glucose ≥≥ 300 mg/dl) by 50 mg/dl within 60 minutes by insulin bolus via the pump. Secondary outcomes included intervals between infusion set changes, treatment-emergent adverse events (TEAEs) including infusion site, hypersensitivity reactions and hypoglycemic events, and safety.Results:The number of patients reporting at least one ISO was small: 6/25 patients on...