SAFETY AND PHARMACOKINETICS OF TECHNOSPHERE INSULIN IN PEDIATRIC PATIENTS

Session Name
NEW INSULIN DELIVERY SYSTEMS: INHALED, TRANSDERMA, IMPLANTED DEVICES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:34 - 09:35
Presenter
  • David Kendall, United States of America
Authors
  • Mashall Grant, United States of America
  • John Krueger, United States of America
  • Mark Fineman, United States of America
  • Gaurav Sharma, United States of America
  • Frank Pompilio, United States of America
  • David Kendall, United States of America

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.

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