Inhaled Insulin for Diabetes in Children

(INHALE-1 Trial)

Recruiting at 58 trial locations

Overseen By Steven Willi, MD

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.

Research Team

Kevin Kaiserman

Principal Investigator

Mannkind Corporation

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.

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.

Treatment Details

Interventions

• Afrezza (Insulin)
• Basal Insulin (Insulin)
• Insulin Aspart (Insulin)
• Insulin Glulisine (Insulin)
• Insulin Lispro (Insulin)

Trial Overview 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.

Participant Groups

Group I: Afrezza (Technosphere Insulin) + Basal Insulin Experimental Treatment 2 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 Insulin Active Control 2 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.

Who Is Running the Clinical Trial?

Mannkind Corporation

Lead Sponsor

Trials

61

Recruited

8,400+

Michael E. Castagna

Mannkind Corporation

Chief Executive Officer since 2017

PharmD from Massachusetts College of Pharmacy & Sciences, MBA from The Wharton School of Business at the University of Pennsylvania

Burkhard Blank

Mannkind Corporation

Chief Medical Officer since 2021

MD

Jaeb Center for Health Research

Collaborator

Trials

162

Recruited

36,200+