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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: Recruiting Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Mannkind Corporation.
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 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (42% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-02 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT07224321 shows while recruiting
NCT07224321 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (42% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07224321's enrollment target sits among peer trials
100 33rd of 112 higher than 80 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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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