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

INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin 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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Technosphere Insulin; Drug: Technosphere Insulin; Drug: Basal insulin

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jennifer Pleitez; Phone Number: 818-661-5032; Email: jpleitez@mannkindcorp.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Not yet recruiting
      • Children's Hospital Los Angeles
      • Contact: Pamela Parcon; Phone Number: 323-203-8744; Email: pparcon@chla.usc.edu
      • Principal Investigator: Roshi Monzavi, MD
    • San Francisco, California, United States, 94158
      • Not yet recruiting
      • University of California San Francisco
      • Principal Investigator: Laya Ekhlaspour, MD
      • Contact: Avani Narayan; Phone Number: 415-530-8047; Email: Avani.Narayan@ucsf.edu
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Barbara Davis Center for Diabetes Young Adult Clinic
      • Principal Investigator: Gregory Forlenza, MD
      • Contact: Cari Berget; Phone Number: 303-724-8977; Email: cari.berget@cuanschutz.edu
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Not yet recruiting
      • Yale University
      • Principal Investigator: Jennifer Sherr, MD
      • Contact: Amy Steffen, BSN; Phone Number: 203-737-8852; Email: Amy.steffen@yale.edu
  • Florida
    • Gainesville, Florida, United States, 32610
      • Not yet recruiting
      • University of Florida
      • Contact: Sarah Peeling; Phone Number: 352-273-5275; Email: smpeeling@peds.ufl.edu
      • Principal Investigator: Brittany Bruggeman, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Principal Investigator: Linda DiMeglio, MD
      • Contact: Sana Kalaji; Phone Number: 317-274-0306; Email: skalaji@iu.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Joslin Diabetes Center
      • Principal Investigator: Lori Laffel, MD
      • Contact: Kerry Milaszewski; Phone Number: 617-975-8209; Email: Kerry.Milaszewski@joslin.harvard.edu
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Not yet recruiting
      • University of Oklahoma Health Sciences Center
      • Principal Investigator: David Sparling, MD
      • Contact: Deidre Graham, RN; Phone Number: 34284 405-271-8001; Email: deidre-graham@ou.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Baylor College of Medicine
      • Principal Investigator: Daniel DeSalvo, MD
      • Contact: Anh Nguyen; Phone Number: 832-822-3870; Email: anh.nguyen2@bcm.edu
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Sara Prince; Phone Number: 434-320-5599; Email: SP4SA@uvahealth.org
      • Principal Investigator: Melissa Schoelwer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afrezza (Technosphere Insulin) + Basal Insulin; Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.	Drug: Technosphere Insulin; 2 unit; Other Names: Afrezza; Drug: Technosphere Insulin; 4, 8, 12 units; Other Names: Afrezza; Drug: Basal insulin; subcutaneously-injected basal insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%	Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Continuous Glucose Monitoring (CGM) glucose	Mean CGM glucose from baseline to 13 weeks	13 weeks
Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL	Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL from baseline to 13 weeks	13 weeks
Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL	CGM-measured percent time with glucose > 180 mg/dL from baseline to 13 weeks	13 weeks
Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL	Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL from baseline to 13 weeks	13 weeks
Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL	Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL from baseline to 13 weeks	13 weeks
Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL	Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL from baseline to 13 weeks	13 weeks
Continuous Glucose Monitoring (CGM) measured coefficient of variation	CGM-measured coefficient of variation from baseline to 13 weeks	13 weeks
Change in glycated hemoglobin (HbA1c)	Change in HbA1c from baseline to 13 weeks	13 weeks
Percentage of participants using Afrezza and basal insulin (Afrezza-BI) regimen	Percentage of participants using Afrezza-BI regimen at time of 13-week visit	At 13 weeks
Percentage of participants that continue on the Afrezza and basal insulin (Afrezza-BI) regimen	Percentage of participants that continue on Afrezza-BI after 13-week visit	After 13 weeks
Incidence of Adverse Events of Special Interest (AESIs)	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	13 weeks
Incidence of Adverse Events of Special Interest (AESIs)	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	39 weeks
Change in percent predicted FEV1	Change in percent predicted FEV1 from baseline to Week 13	13 weeks
Change in percent predicted FEV1	Change in percent predicted FEV1 from baseline to Week 39	39 weeks
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Incidence and severity of TEAEs and SAEs	13 weeks
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Incidence and severity of TEAEs and SAEs	39 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver	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.	13 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant	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 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver	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.	39 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant	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.	39 weeks

Collaborators and Investigators

• Sponsor: Mannkind Corporation
• Collaborators: Jaeb Center for Health Research

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Actual): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Insulin; Diabetes Mellitus; Pediatric; Type 1 Diabetes; Newly diagnosed type 1 diabetes; Inhaled; Afrezza; Technosphere; Inhaled Insulin; Technosphere Insulin; rapid-acting inhaled insulin; Meal-time inhaled insulin
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Respiration Disorders; Glucose Metabolism Disorders; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus; Respiratory Aspiration; Diabetes Mellitus, Type 1; Insulin Resistance; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Proinsulin; Insulin
• Other Study ID Numbers: MKC-TI-196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No