Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
Public ClinicalTrials.gov record NCT02527265. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02527265
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 27, 2017
- Primary completion
- Mar 16, 2020
- Completion
- Jun 24, 2020
- Last update posted
- Apr 5, 2021
2017 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | — |
| Yale University Hospital | New Haven | Connecticut | 06510 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| USF Diabetes Center | Tampa | Florida | 33612 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| Van Meter Pediatric Endocrinology, P.C. | Atlanta | Georgia | 30318 | — |
| Emory University Children's Center | Atlanta | Georgia | 30322 | — |
| Indiana University, Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Barry J. Reiner, MD, LLC | Baltimore | Maryland | 21229 | — |
| Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) | Las Vegas | Nevada | 89113 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02527265, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02527265 live on ClinicalTrials.gov.