Open-label, single-arm, multiple-dose safety, titration, and pharmacokinetic study of AFREZZA® in pediatric subjects ages 4 to 17 years with type 1 diabetes mellitus

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Updated on 19 February 2024

Summary

The purpose of this research study is to measure how much of the study drug (Afrezza) gets into your blood
after a single dose and measure how well it works to control your blood sugar level. We also want to make sure
this study drug is safe for children and adolescents between 4 and 17 years old.

Details
Condition type 1 diabetes mellitus
Age 4years - 12years
Clinical Study IdentifierTX10301
Last Modified on19 February 2024

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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