Inhaled Insulin for Diabetes in Children
(INHALE-1 Trial)

Recruiting in Palo Alto (17 mi)

+58 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Mannkind Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests an inhalable insulin called Afrezza, combined with a long-acting insulin, in children and teenagers with diabetes. Afrezza helps lower blood sugar quickly after eating, and the long-acting insulin keeps it stable all day. The study aims to see if this combination is safe and effective.

Eligibility Criteria

This trial is for kids aged 4-17 with type 1 or type 2 diabetes who have been on insulin therapy and use a continuous glucose monitor (CGM) regularly. They need an HbA1c between 7% and 11%, take at least 2 units of insulin per meal, and have stable internet. Kids can't join if they've had severe hypoglycemia recently, uncontrolled eating disorders, significant lung problems, recent drug/alcohol abuse, or are pregnant.

Inclusion Criteria

I have diabetes and have been using insulin for the required time.

You have used continuous glucose monitoring for at least 70% of the time over a 14-day period before joining the study.

I am using insulin glargine, degludec, or detemir for my diabetes.

+7 more

Exclusion Criteria

I have asthma or another serious lung or heart condition.

Exposure to any investigational product(s), including drugs or devices, in the past 30 days

You had a very low blood sugar event in the last 90 days.

+15 more

Participant Groups

The INHALE-1 study tests Afrezza inhaled insulin combined with long-lasting basal insulin against standard rapid-acting injected insulins plus basal insulin in children. After a six-month comparison phase, all participants will switch to Afrezza for another six months to check its longer-term safety and effectiveness.

2Treatment groups

Experimental Treatment

Active Control

Group I: Afrezza (Technosphere Insulin) + Basal InsulinExperimental Treatment2 Interventions

Individualized dose of Afrezza (Technosphere Insulin) for each patient before each meal (breakfast, lunch, and dinner) for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient.

Group II: RAA Injection + Basal InsulinActive Control2 Interventions

Individualized dose of RAA injection (insulin aspart, insulin lispro or insulin glulisine) for each patient for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient.