NCT02527265

Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Afrezza	Pharmaceutical form: powder Route of administration: inhalation

Timeline

• Start date: 2017-09-28
• Primary completion: 2020-03-17
• Completion: 2020-06-25
• First posted: 2015-08-18
• Last updated: 2021-04-06
• Results posted: 2021-04-06

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study