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Published on: May 10, 2018
Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes
Michael J Haller1, Marisa C Jones2, Sunil Bhavsar2
1University of Florida, Gainesville, FL, USA.
Insights
Technosphere insulin (TI), an inhaled ultra-rapid-acting insulin, showed rapid absorption and glucose-lowering effects in children with type 1 diabetes (T1D). Its pharmacokinetic profile in youth aged 8-17 years was comparable to that observed in adults.
Area of Science:
- Pharmacology and Endocrinology
- Pediatric Endocrinology
- Diabetes Mellitus Research
Background:
- Technosphere insulin (TI) is an inhaled dry powder ultra-rapid-acting insulin.
- This study presents the first investigation of TI in pediatric patients diagnosed with type 1 diabetes (T1D).
Purpose of the Study:
- To evaluate the pharmacokinetics (PK) and glucose-lowering effects of TI in children with T1D.
- To compare the PK profile of TI in pediatric patients to that observed in adult studies.
Main Methods:
- A single-arm study involving 27 children (ages 8-17) with T1D on stable multiple daily insulin injection (MDI) regimens.
- Participants received individualized preprandial doses of TI (4-12 U) via oral inhalation.
- Serum insulin and blood glucose levels were monitored for 250 minutes post-dose.
Main Results:
- Mean Cmax (maximum insulin concentration) ranged from 77.3 to 207.7 µU/mL for TI doses of 4-12 U.
- Tmax (time to maximum concentration) occurred rapidly, between 10.5 and 14.6 minutes post-dose.
- Glucose-lowering effects observed between 30-60 minutes post-dose correlated with the insulin PK profile.
Conclusions:
- Serum insulin levels increased rapidly after TI inhalation and returned to baseline within 120 minutes.
- The pharmacokinetic profile of TI in children aged 8-17 years with T1D was similar to that previously reported in adult studies.
- TI demonstrates a rapid absorption and action profile suitable for preprandial glucose management in pediatric T1D.
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 Cmax (maximum concentration) was 77.3, 119.15, and 207.7 µU/mL for doses of 4, 8, and 12 U, respectively. Tmax 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.
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