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NCT07224321 · ClinicalTrials.gov registry record · Phase 2

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Mannkind Corporation.

Recruiting
Registry status
Phase 2
Development phase
100
Enrollment target
2
Study locations

NCT07224321 is a Phase 2 study of Type 1 Diabetes Mellitus that is actively recruiting participants, run by Mannkind Corporation. The registered enrollment target is 100 participants, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (28% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT07224321, a Phase 2 study of Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by Mannkind Corporation.

RECRUITING
Registry status
Phase 2
Development phase
100 participants
Enrollment target
2
Study locations

Study Summary

INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to \<18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent/legally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.

Conditions Studied

Type 1 Diabetes Mellitus

Interventions

  • DRUG Technosphere Insulin
  • DRUG Basal insulin

Study Locations (2)

Colorado

  • Barbara Davis Center for Diabetes Young Adult Clinic - Aurora

Massachusetts

  • Joslin Diabetes Center - Boston

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2026-02
Est. Completion 2027-07
Phase Phase 2

Sponsor

Mannkind Corporation

42 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07224321

The ClinicalTrials.gov registry entry for NCT07224321 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (28% lower). The listed sponsor is Mannkind Corporation, which has 42 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Technosphere Insulin is the first listed.

NCT07224321 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07224321 about?

NCT07224321 is a clinical study titled "INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes". INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to \<18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of...

What is the current status of trial NCT07224321?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2026-02. Estimated completion is 2027-07.

What conditions does trial NCT07224321 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.

What interventions are being tested in trial NCT07224321?

The interventions under investigation include: Technosphere Insulin (DRUG), Basal insulin (DRUG).

Who is sponsoring clinical trial NCT07224321?

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

Where is trial NCT07224321 being conducted?

This trial has 2 study locations across Colorado, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.