Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07224321

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 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10 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

Treatment and study plan

Technosphere Insulin

Drug

2 unit

Other names: Afrezza

Basal Insulin

Drug

subcutaneously-injected basal insulin

Primary outcomes

  1. Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%

    Time frame: 13 weeks

    Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit

Secondary outcomes

  1. Mean Continuous Glucose Monitoring (CGM) glucose

    Time frame: 13 weeks

    Mean CGM glucose from baseline to 13 weeks

  2. Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL

    Time frame: 13 weeks

    Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL from baseline to 13 weeks

  3. Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL

    Time frame: 13 weeks

    CGM-measured percent time with glucose > 180 mg/dL from baseline to 13 weeks

  4. Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL

    Time frame: 13 weeks

    Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL from baseline to 13 weeks

  5. Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL

    Time frame: 13 weeks

    Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL from baseline to 13 weeks

  6. Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL

    Time frame: 13 weeks

    Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL from baseline to 13 weeks

  7. Continuous Glucose Monitoring (CGM) measured coefficient of variation

    Time frame: 13 weeks

    CGM-measured coefficient of variation from baseline to 13 weeks

  8. Change in glycated hemoglobin (HbA1c)

    Time frame: 13 weeks

    Change in HbA1c from baseline to 13 weeks

  9. Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver

    Time frame: 13 weeks

    Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16; now listed as 1-5) and Delivery System subscale (items 17-22; now listed as 6-11) and one additional item added by study team (#12). Higher scores indicate less treatment satisfaction.

  10. Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant

    Time frame: 13 weeks

    Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16) and Delivery System subscale (items 17-22). Higher scores indicate less treatment satisfaction.

  11. Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver

    Time frame: 39 weeks

    Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16; now listed as 1-5) and Delivery System subscale (items 17-22; now listed as 6-11) and one additional item added by study team (#12) Higher scores indicate less treatment satisfaction.

  12. Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant

    Time frame: 39 weeks

    Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16) and Delivery System subscale (items 17-22) Higher scores indicate less treatment satisfaction.

  13. Percentage of participants using Afrezza and basal insulin (Afrezza-BI) regimen

    Time frame: At 13 weeks

    Percentage of participants using Afrezza-BI regimen at time of 13-week visit

  14. Percentage of participants that continue on the Afrezza and basal insulin (Afrezza-BI) regimen

    Time frame: After 13 weeks

    Percentage of participants that continue on Afrezza-BI after 13-week visit

  15. Incidence of Adverse Events of Special Interest (AESIs)

    Time frame: 13 weeks

    Incidence and severity of AESIs which include the following events: acute bronchospasm, clinically relevant decline in pulmonary function (>15% decline from baseline percent predicted FEV1 accompanied by respiratory symptoms), hypersensitivity reactions, including anaphylaxis, hospitalization for asthma, use of corticosteroid bursts for diagnosis of asthma, diagnosis of asthma, diabetic ketoacidosis, severe hypoglycemia

  16. Incidence of Adverse Events of Special Interest (AESIs)

    Time frame: 39 weeks

    Incidence and severity of AESIs which include the following events: acute bronchospasm, clinically relevant decline in pulmonary function (>15% decline from baseline percent predicted FEV1 accompanied by respiratory symptoms), hypersensitivity reactions, including anaphylaxis, hospitalization for asthma, use of corticosteroid bursts for diagnosis of asthma, diagnosis of asthma, diabetic ketoacidosis, severe hypoglycemia

  17. Change in percent predicted FEV1

    Time frame: 13 weeks

    Change in percent predicted FEV1 from baseline to Week 13

  18. Change in percent predicted FEV1

    Time frame: 39 weeks

    Change in percent predicted FEV1 from baseline to Week 39

  19. Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 13 weeks

    Incidence and severity of TEAEs and SAEs

  20. Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 39 weeks

    Incidence and severity of TEAEs and SAEs

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Pleitez

CONTACT

[email protected]

818-661-5032

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Collaborators

  • Jaeb Center for Health Research

Registry information

Official study title

INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes

Acronym: INHALE-1st

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.