Time–Action Profile of Technosphere Insulin in Children with Type 1 Diabetes
Open accessAbstract
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: 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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- Authors
- Haller, M. J., Jones, M. C., Bhavsar, S., & Kaiserman, K. B.
- Affiliations
- University of Florida (US)
- MannKind Corporation (United States) (US)
- Corresponding author
- Kaiserman, Kevin B.
- Venue
- Diabetes Therapy
- Published
- 2023-01-18
- Volume
- 14
- Issue
- 3
- Pages
- 611-617
- ISSN
- 1869-6953 (ISSN-L)
- 1869-6961
- PMC
- PMC9981820
- OpenAlex
- W4317208429
- Cited by
- 16
- References
- 17
- Citations by year
- 2026: 11 · 2025: 4 · 2024: 1
- FWCI
- 3.28
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Diabetes Therapy (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- MannKind Corporation
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Inhalation and Respiratory Drug Delivery
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- Technosphere insulin, inhaled insulin, type 1 diabetes, children, pharmacokinetics, ultra-rapid-acting insulin, serum insulin, blood glucose, lung function, multiple daily insulin injections, oral inhalation
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