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

MannKind

Status and phase: Enrolling; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Technosphere Insulin; Drug: Basal insulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07224321

MKC-TI-196

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Afrezza (Technosphere Insulin) + Basal Insulin

Experimental group

Description:

Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.

Treatment:

Drug: Technosphere Insulin

Drug: Basal insulin

Drug: Technosphere Insulin