Introduction: Technosphere insulin (TI) is an inhaled dry powder ultra-rapid-acting insulin. This report describes the results of the first study of TI in children with type 1 diabetes (T1D).

Methods: Pharmacokinetics (PK) of TI and the effect of TI on circulating glucose concentrations were evaluated in a single-arm study that enrolled children ages 8-17 years with T1D for more than 1 year, on a stable multiple daily insulin injection (MDI) regimen, and meeting pre-defined pulmonary function testing criteria (at least 70% predicted). To assess PK, subjects received an individualized single preprandial dose of TI (4-12 U, in 4-U increments) via oral inhalation, based on their usual meal-time subcutaneously injected rapid-acting insulin dose and meal content. Serum insulin and blood glucose were measured at - 30 to 250 min relative to dosing.

Results: Twenty-seven children with T1D participated in this single-dose PK study. Mean subject age was 13.3 years (59% female; 81.5% White). Mean serum insulin C_max (maximum concentration) was 77.3, 119.15, and 207.7 µU/mL for doses of 4, 8, and 12 U, respectively. T_max occurred at 10.5, 13.9, and 14.6 min post-dose for 4, 8, and 12 U. Glucose lowering 30-60 min post-dose was consistent with the PK profile.

Conclusion: Serum insulin rapidly increased post-dose and returned to baseline by 120 min. The data suggests the PK of TI in youth with T1D ages 8-17 years was similar to that seen in previous adult studies.

Trial registration: ClinicalTrials.gov identifier, NCT02527265.