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Diabetes Mellitus, Type 1Phase 3INHALE-1NCT04974528

Afrezza® INHALE-1 Study in Pediatrics

A Phase 3 study testing Afrezza, Rapid-acting Insulin Analog and Basal Insulin in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Mannkind Corporation at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog [RAA] injection… Read more about this study

Who is it for?
Ages 4 to 17 years
What is being tested?
Afrezza, Rapid-acting Insulin Analog and Basal Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
39 sitesUnited States
Study dates
29 Sep 2021to 29 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian, as required by both state and federal laws and the local Institutional Review Board (IRB)
  • Subjects ≥4 and <18 years of age
  • Clinical diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) per the Investigator and have been using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
  • Treatment with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
  • Bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
  • Basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
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  • Access to stable WiFi connection
  • HbA1c ≥7.0% and ≤11%
  • Average prandial dose of insulin ≥2 units per meal
  • Utilized CGM for ≥70% of the time over a consecutive 14-day period preceding randomization

Who cannot join

  • History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements
  • Recent history of asthma (defined as using any medications to treat within the last year), any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
  • History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy), or likely need for specific treatment for diabetic retinopathy (laser photocoagulation, vitrectomy, other) in the next year
  • FEV1 and FEV1/forced vital capacity (FVC) ≤80% of predicted Global Lung Function Initiative (GLI) value
  • Inability to achieve an acceptable FEV1 and FVC reading for subjects ≥8 years of age would make the subject ineligible
  • For subjects <8 years of age who are unable to achieve an acceptable FVC reading, FEV1 only may be assessed; inability to achieve an acceptable FEV1 would make the subject ineligible
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  • Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
  • Inability or unwillingness to perform study procedures
  • Exposure to any investigational product(s), including drugs or devices, in the past 30 days
  • Any disease other than diabetes or exposure to any medication that, in the judgment of the Investigator, may impact glucose metabolism and current or anticipated acute uses of glucocorticoids or weight loss medications, with the exception of metformin and/or GLP-1 agonists (if GLP-1 agonists used for at least the 3 months prior to enrollment) in subjects with T2DM
  • Use of antiadrenergic drugs (e.g., clonidine)
  • Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
  • Current uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)
  • Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the Investigator or the Sponsor, would make the subject an unsuitable candidate for participation in the study
  • Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months and/or positive urine cotinine test
  • Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential, sexually active and not using adequate contraceptive methods as required by local regulation or practice
  • An event of severe hypoglycemia, as judged by the Investigator, within the last 90 days prior to screening
  • An episode of DKA requiring hospitalization within the last 90 days prior to screening

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Emory University, Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329

  • Dr. Barry J. Reiner

    Baltimore, Maryland, 21229

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee, 38133

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • UBMD Pediatrics Buffalo

    Buffalo, New York, 14203

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • UT Southwestern

    Dallas, Texas, 75390

  • DHR Health

    Edinburg, Texas, 78539

  • University of Florida

    Gainesville, Florida, 32610

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • Children's Mercy Hospital

    Kansas City, Missouri, 64111

  • The DOCS

    Las Vegas, Nevada, 89113

  • Michigan Pediatric Endocrine and Diabetes Services

    Livonia, Michigan, 48152

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of Louisville, Norton Children's Hospital

    Louisville, Kentucky, 40202

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53201

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Atlantic Health

    Morristown, New Jersey, 07960

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

  • NYU Langone, Hassenfeld Children's Hospital

    New York, New York, 10016

  • Oklahoma Children's Hospital

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Advent Health Orlando

    Orlando, Florida, 32803

  • Stanford University

    Palo Alto, California, 94304

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Sutter Institute for Medical Research (formerly Center of Excellence in Diabetes and Endocrinology)

    Sacramento, California, 95821

  • Diabetes & Glandular Disease Clinic, DGD

    San Antonio, Texas, 78229

  • University of California San Diego, Rady Children's Hospital

    San Diego, California, 92123

  • University of California San Francisco

    San Francisco, California, 94158

  • Seattle Children's

    Seattle, Washington, 98105

  • University of South Florida

    Tampa, Florida, 33612

  • Iowa Diabetes Research, IDR

    West Des Moines, Iowa, 50265

  • Nemours Children's Hospital, Delaware

    Wilmington, Delaware, 19803

Other trials in United States

About this study

Official 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

INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog [RAA] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza.

Pediatric subjects ≥4 and <18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group.

Read more

The study is composed of:

  • Up to 5-week screening/run-in period
  • 26 week randomized treatment period
  • 26-week treatment extension
  • 4-week follow-up period
Being tested
Afrezza, Rapid-acting Insulin Analog, Basal Insulin
Keywords
Diabetes Mellitus, Insulin, Inhaled, Afrezza, Technosphere, Pediatric
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfrezzaBiological

    Also called Technosphere Insulin

    Pharmaceutical form: powder

    Route of administration: inhalation

  • Rapid-acting Insulin AnalogBiological

    Also called insulin aspart, insulin lispro, insulin glulisine, Novolog®

    Pharmaceutical form: clear and colorless solution for injection

    Route of administration: subcutaneous

  • Basal InsulinBiological

    Also called insulin glargine, insulin degludec, insulin detemir, Lantus®

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

Study groups in NCT04974528
Study groupRoleWhat they receive
Afrezza (Technosphere Insulin) + Basal InsulinExperimentalIndividualized dose of Afrezza (Technosphere Insulin) for each patient before each meal (breakfast, lunch, and dinner) for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient.
Receives: Biological: Afrezza; Biological: Basal Insulin
RAA Injection + Basal InsulinActive comparatorIndividualized dose of RAA injection (insulin aspart, insulin lispro or insulin glulisine) for each patient for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient.
Receives: Biological: Rapid-acting Insulin Analog; Biological: Basal Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change in HbA1c from baseline to Week 26, for noninferiority assessment

    Measured: 26 weeks

Secondary outcomes (3)

  1. Change in Fasting Plasma Glucose (FPG)

    Change in FPG from baseline to Week 26, for superiority assessment

    Measured: 26 weeks

  2. Event rate of pooled level 2 and level 3 hypoglycemia

    Event rate of pooled level 2 and level 3 hypoglycemia (SMBG < 54 mg/dL and/or severe hypoglycemic events reported on the adverse event CRF) during the 26 -week randomized treatment period, for superiority assessment.

    Measured: 26 weeks

  3. Change in HbA1c

    Change in HbA1c from baseline to Week 26, for superiority assessment

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start29 Sep 2021
  3. Primary completion3 Oct 2024
  4. Study completion29 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974528
Sponsor's protocol ID
MKC-TI-155 Part 2
Acronym
INHALE-1
Status last verified
May 2025
First submitted
22 Jun 2021
Last updated
6 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Afrezza, Rapid-acting Insulin Analog and Basal Insulin in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Mannkind Corporation at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04974528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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