Inhaled Insulin for Diabetes in Children
(INHALE-1 Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you have been using certain types of insulin for a while. You should discuss your current medications with the study team to see if they fit the trial's requirements.
Is inhaled insulin safe for children with diabetes?
The studies reviewed focus on the safety of different insulin formulations in adults with type 1 and type 2 diabetes, showing that these insulins are generally safe and effective for managing blood sugar levels. However, specific safety data for inhaled insulin in children is not provided in these studies.12345
How is inhaled insulin for diabetes in children different from other diabetes drugs?
Inhaled insulin, like Afrezza, offers a unique way to manage diabetes by allowing insulin to be absorbed through the lungs, providing a faster onset of action compared to traditional subcutaneous injections. This can lead to improved blood sugar control after meals and may be more convenient for children who are uncomfortable with injections.13678
What data supports the effectiveness of the drug Afrezza and other insulins for diabetes in children?
Research shows that insulin aspart and insulin lispro, which are components of the treatment, are effective in controlling blood sugar levels in people with diabetes. Studies have demonstrated that these insulins can improve blood sugar control after meals and reduce the risk of low blood sugar at night.12379
Who Is on the Research Team?
Kevin Kaiserman
Principal Investigator
Mannkind Corporation
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Afrezza or RAA injection combined with a basal insulin for 26 weeks
Treatment Extension
All subjects receive Afrezza to assess safety and efficacy with continued use until Week 52
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Afrezza
- Basal Insulin
- Insulin Aspart
- Insulin Glulisine
- Insulin Lispro
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mannkind Corporation
Lead Sponsor
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