Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT02527265
- Lead Sponsor
- Mannkind Corporation
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Insulin Maximum Observed Concentration (Cmax) 250 minutes post-dose Insulin Cmax after a dose of Afrezza
- Secondary Outcome Measures
Name Time Method Insulin Time to Reach Cmax (Tmax) 250 minutes post-dose Insulin Tmax after a dose of Afrezza
Insulin Area Under Concentration Time Curve (AUC) 250 minutes post-dose Insulin AUC after a dose of Afrezza
Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2) Using PK data collected over 250 minutes post-dose of Afrezza FDKP (inert carrier excipient) calculated half life t1/2
Trial Locations
- Locations (13)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, United States
Yale University Hospital
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
USF Diabetes Center
🇺🇸Tampa, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Van Meter Pediatric Endocrinology, P.C.
🇺🇸Atlanta, Georgia, United States
Emory University Children's Center
🇺🇸Atlanta, Georgia, United States
Indiana University, Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Barry J. Reiner, MD, LLC
🇺🇸Baltimore, Maryland, United States
Scroll for more (3 remaining)Children's Hospital Los Angeles🇺🇸Los Angeles, California, United States