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

NCT07224321 | Recruiting Phase 2 FDA Drug

• 1 other identifier: MKC-TI-196
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus; Insulin; Inhaled; Afrezza; Technosphere; Pediatric; Inhaled Insulin; Type 1 Diabetes; Newly diagnosed type 1 diabetes; Technosphere Insulin; rapid-acting inhaled insulin; Meal-time inhaled insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Mean Continuous Glucose Monitoring (CGM) glucose

  13 weeks

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

  13 weeks

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

  13 weeks

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

  13 weeks

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

  13 weeks

Study Arms (1)

Afrezza (Technosphere Insulin) + Basal Insulin

EXPERIMENTAL

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; Drug: Basal insulin

Interventions

Technosphere Insulin DRUG

2 unit

Also known as: Afrezza

Afrezza (Technosphere Insulin) + Basal Insulin

Basal insulin DRUG

subcutaneously-injected basal insulin

Afrezza (Technosphere Insulin) + Basal Insulin

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mannkind Corporation: lead
• Jaeb Center for Health Research: collaborator

Study Sites (10)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

NOT YET RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

NOT YET RECRUITING

Barbara Davis Center for Diabetes Young Adult Clinic

Aurora, Colorado, 80045, United States

RECRUITING

Yale University

New Haven, Connecticut, 06511, United States

NOT YET RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

NOT YET RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance; Respiratory Aspiration

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jennifer Pleitez

CONTACT

818-661-5032; jpleitez@mannkindcorp.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (10)