At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Afrezzabiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Afrezza for Type 1 Diabetes Mellitus. Completed, enrolled 30 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2017
Primary CompletionMar 2020
Study CompletionJun 2020
TodayJul 2026
First PostedAug 18, 2015
Enrollment StartSep 28, 2017
Primary CompletionMar 17, 2020
Study CompletionJun 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.9 years ago
Interventions
Afrezzabiological
Pharmaceutical form: powder Route of administration: inhalation