Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

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.

Timeline

Start

2017-09-28

Primary completion

2020-03-17

Completion

2020-06-25

Publications

• Haller MJ, Jones MC, Bhavsar S, Kaiserman KB. Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes. Diabetes Ther. 2023 Mar;14(3):611-617. doi: 10.1007/s13300-023-01368-7. Epub 2023 Jan 18.

Drugs

Indications