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

NCT ID: NCT07224321

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Technosphere Insulin

Intervention Type: DRUG

2 unit

Technosphere Insulin

Intervention Type: DRUG

4, 8, 12 units

Basal insulin

Intervention Type: DRUG

subcutaneously-injected basal insulin

Interventions

Technosphere Insulin

2 unit

Intervention Type: DRUG

Technosphere Insulin

4, 8, 12 units

Intervention Type: DRUG

Basal insulin

subcutaneously-injected basal insulin

Intervention Type: DRUG

Other Intervention Names

Afrezza; Afrezza

Eligibility Criteria

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 10 days following T1D diagnosis (day 1 is based on the first insulin injection) if not hospitalized with diabetic ketoacidosis (DKA) and within 10 days of hospital discharge if hospitalized with DKA
• 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
• 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) in the judgment of the investigator
• 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barbara Davis Center for Diabetes Young Adult Clinic

Aurora, Colorado, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Jennifer Pleitez

Role: CONTACT

jpleitez@mannkindcorp.com

818-661-5032

Facility Contacts

Cari Berget

Role: primary

cari.berget@cuanschutz.edu

303-724-8977

Kerry Milaszewski

Role: primary

Kerry.Milaszewski@joslin.harvard.edu

617-732-2603

Other Identifiers

MKC-TI-196

Identifier Type: -

Identifier Source: org_study_id