An AllTrials project

NCT04974528: An overdue trial by Mannkind Corporation

This trial is overdue. It was due to report 2 months, 1 week ago.

Think we've made a mistake? Before contacting us, review the criteria in our paper. In particular, bear in mind the following:

  • We can only rely on the structured data that sponsors put into the registry: they may enter incorrect or incomplete data.
  • Reporting in a journal is not enough. The FDAAA rules state that the trial must be reported on ClinicalTrials.gov.
  • Terminated trials are required to report results. Only withdrawn trials (which never recruited a single patient) are not.

Full data

Full entry on ClinicalTrials.gov NCT04974528
Title INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus
Results Status Overdue
ACT or pACT? This is what FDAAA officially calls an "Applicable Clinical Trial"
Start date Sept. 29, 2021
Completion date Oct. 3, 2024
Required reporting date Oct. 3, 2025, midnight
Actual reporting date None
Date last checked at ClinicalTrials.gov Dec. 12, 2025
Days late 70