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New inhaled insulin combo aims to simplify diabetes care for teens

NCT ID NCT07224321

Disease control Sponsor: Mannkind Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests a new approach for teens (ages 10-17) recently diagnosed with type 1 diabetes. They will use an inhaled insulin called Afrezza along with a long-acting injected insulin. The goal is to see if this combination helps keep blood sugar in a healthy range and is safe and satisfying for patients and families. The main part lasts 13 weeks, with an optional extension up to 26 weeks.

Why investors are watching

MannKind is testing Afrezza, its inhaled insulin, in children and teens newly diagnosed with type 1 diabetes. The trial combines Afrezza with a standard injected basal insulin, and it measures both blood sugar control and patient satisfaction. For a small company whose product is already approved in adults, a positive result in this younger, newly diagnosed group could open a much larger and earlier-use patient population.

If it works: A successful readout could support expanding Afrezza's label to include youth, giving MannKind a new revenue stream and a foothold in early-stage diabetes care. It could also strengthen the case for Afrezza as a first-line option rather than a later-stage add-on.

If it fails: The trial could fail to show adequate safety or efficacy in children, or the small single-arm design may produce results regulators find unconvincing. Trials in this age group often face recruitment and adherence challenges, and a delay or negative outcome would set back the company's expansion plans without any guarantee of recovery.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 6 to \<18 years of age * Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria * Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose) * Forced Expiratory Volume in One Second (FEV1) \>80.0% of predicted Global Lung Function Initiative (GLI) value * Investigator believes that participant can be expected to follow the study protocol * No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study Exclusion Criteria: * Prior insulin treatment for stage 2 T1D * In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia) * Allergy or known hypersensitivity to human regular insulin * Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for smoking * Positive urine pregnancy test for female subjects of childbearing potential

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Insulin Resistance Respiratory Aspiration type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barbara Davis Center for Diabetes Young Adult Clinic

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Florida

    RECRUITING

    Gainsville, Florida, 32610, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States

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Other studies related to the condition(s) this trial covers.