Abstract
Background and Aims
Technosphere Insulin (TI), an ultra-rapid, short-acting inhaled insulin, provides glycemic control in patients with diabetes. This ongoing, 2-part, open-label, interventional study (NCT02527265) aims to assess efficacy and safety of TI in children aged 4 to 17 years with type 1 diabetes (T1D) who are receiving a stable regimen of basal-bolus insulin.
Methods
Part 1, a single-arm study, includes evaluation of insulin pharmacokinetics (PK) after a single prandial dose of TI (4, 8, or 12 U), followed by a 4-week titration period. Approximately 46 patients will be enrolled across 3 cohorts: cohorts 1 (13-17 years), 2 (8-12 years), and 3 (4-7 years).
Results
Initial PK results from cohort 1 demonstrated insulin metabolism similar to that in adult patients receiving TI. Insulin concentrations rapidly increased in the first 30 minutes after TI treatment and returned to baseline by 120 minutes for the 4-, 8-, and 12-U doses. Mean postprandial glucose levels decreased within 1-hour postdose for the 8- and 12-U doses. Seven patients developed treatment-related cough of mild (6 events) or moderate (1 event) severity; 7 patients experienced a total of 41 hypoglycemic events; no patients required the assistance of another person to administer corrective carbohydrates. No clinically relevant declines in pulmonary function were reported. Two patients discontinued because of adverse events (cough, diabetic ketoacidosis).
Conclusions
These data will help determine the appropriate age range for inclusion and recommended dosing for part 2, which will be a 1-year efficacy and safety study.