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NCT05904743 · ClinicalTrials.gov registry record · Phase 4

INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

A Phase 4 study, sponsored by Mannkind Corporation.

Completed
Registry status
Phase 4
Development phase
141
Enrollment target

NCT05904743: Completed Phase 4 study, sponsored by Mannkind Corporation.

NCT05904743 is a Phase 4 study that has completed, run by Mannkind Corporation. The registered enrollment target is 141 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05904743, a Phase 4 study, has completed, sponsored by Mannkind Corporation.

COMPLETED
Registry status
Phase 4
Development phase
141 participants
Enrollment target

Study Summary

INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.

Primary Outcome

Change in HbA1c from baseline to 17 weeks (non-inferiority margin 0.4%)

Interventions

  • BIOLOGICAL Afrezza
  • BIOLOGICAL Rapid-acting Insulin Analog
  • BIOLOGICAL Basal Insulin
  • BIOLOGICAL insulin degludec

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2023-07-07
Est. Completion 2024-06-24
Phase Phase 4
Mannkind Corporation

42 total trials

What the finished NCT05904743 record still lists

NCT05904743 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 4 interventions - of which Afrezza is the first listed.

NCT05904743 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05904743 about?

NCT05904743 is a clinical study titled "INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes". INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to ...

What is the current status of trial NCT05904743?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 141 participants. The study started on 2023-07-07. Estimated completion is 2024-06-24.

What interventions are being tested in trial NCT05904743?

The interventions under investigation include: Afrezza (BIOLOGICAL), Rapid-acting Insulin Analog (BIOLOGICAL), Basal Insulin (BIOLOGICAL), insulin degludec (BIOLOGICAL).

Who is sponsoring clinical trial NCT05904743?

This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05904743's enrollment target sits among peer trials

141 580th of 2000 higher than 1,420 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05904743, the US trial registry maintained by the National Library of Medicine. NCT05904743 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.