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Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

Type 1 Diabetes Mellitus Clinical Trial

Official title:
Open-label, Single-arm, Multiple-dose Safety, Titration, and Pharmacokinetic Trial of Afrezza® in Pediatric Patients Ages 4 to 17 Years With Type 1 Diabetes Mellitus

Clinical Trial Summary

Primary Objective: -To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM). Secondary Objectives: - To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal. - To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM.

Clinical Trial Description

The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02527265
Study type Interventional
Source Mannkind Corporation
Contact
Status Completed
Phase Phase 2
Start date September 28, 2017
Completion date June 25, 2020
View Details
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