Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Biological: Afrezza
- 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
- Arm && Interventions
Group Intervention Description Afrezza (Technosphere Insulin) Afrezza Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days. During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day.
- 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)
Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS)
🇺🇸Las Vegas, Nevada, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Emory University Children's Center
🇺🇸Atlanta, Georgia, United States
Indiana University, Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Yale University Hospital
🇺🇸New Haven, Connecticut, United States
Barry J. Reiner, MD, LLC
🇺🇸Baltimore, Maryland, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, 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