Inhaled Insulin for Diabetes in Children

(INHALE-1 Trial)

No longer recruiting at 58 trial locations

Overseen By Steven Willi, MD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Mannkind Corporation

Must be taking: Basal-bolus insulin

Must not be taking: Antiadrenergic drugs

Disqualifiers: Asthma, Pulmonary disease, Retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of inhaled insulin, called Afrezza, for children with type 1 or type 2 diabetes. Researchers aim to determine if Afrezza, when used with a long-acting insulin, matches the effectiveness and safety of other fast-acting insulin injections. Children who have used insulin for at least three to six months and manage diabetes daily may qualify for this study. Participants will use either Afrezza or another fast-acting insulin with a long-acting one for 26 weeks, then switch to Afrezza for another 26 weeks to assess long-term effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking diabetes treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that inhaled insulin, such as Afrezza, is safe for children with diabetes. Studies suggest it could serve as a good alternative to traditional insulin shots taken at meal times. In these studies, children handled Afrezza well, and researchers found no serious safety issues. Some children might experience mild problems, like a cough, but these are usually not serious. Overall, Afrezza is considered a safe and effective way to manage diabetes in children. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about inhaled insulin, specifically Afrezza, for managing diabetes in children because it offers a unique delivery method. Unlike traditional insulin injections, Afrezza is inhaled, potentially making it less painful and more convenient for young patients. This method allows insulin to enter the bloodstream more rapidly, which can help better control blood sugar spikes after meals. Additionally, this treatment may improve adherence to insulin therapy in children, making diabetes management less of a hassle for both kids and their caregivers.

What evidence suggests that this trial's treatments could be effective for diabetes in children?

Research has shown that Afrezza, an inhaled insulin, is a safe and effective option for children with diabetes who need fast-acting insulin. In this trial, some participants will receive Afrezza alongside basal insulin. Studies have found that Afrezza can reliably replace injected fast-acting insulin for children with type 1 diabetes. It works quickly to control blood sugar levels after meals. Afrezza offers a new method for children to receive insulin without injections, simplifying diabetes management and reducing pain. Overall, evidence supports Afrezza as a promising treatment for young people with diabetes. ^{1 3 4 6 7}

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

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.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 weeks

Treatment

Participants receive either Afrezza or RAA injection combined with a basal insulin for 26 weeks

26 weeks

Treatment Extension

All subjects receive Afrezza to assess safety and efficacy with continued use until Week 52

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Afrezza
• Basal Insulin
• Insulin Aspart
• Insulin Glulisine
• Insulin Lispro

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.

How Is the Trial Designed?

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+

Citations

1. diabetes.org diabetes.org/newsroom/press-releases/inhaled-insulin-shown-safe-and-effective-replacement-standard-care-children

Inhaled Insulin Shown as a Safe and Effective ... Today, a new study demonstrates inhaled insulin as a safe and effective replacement for rapid-acting meal insulin in children with type 1 ...

2. investors.mannkindcorp.com investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-six-month-results-phase-3-inhale-1-pediatric

MannKind Announces Six-Month Results From Phase 3 ... The six-month results are clinically meaningful and show Afrezza as a potential future treatment option for a growing pediatric population living with type 1 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9981820/

Time–Action Profile of Technosphere Insulin in Children with ... This report describes the results of the first study of TI in children with type 1 diabetes (T1D). Methods. Pharmacokinetics (PK) of TI and the effect of TI on ...

4. healio.com healio.com/news/endocrinology/20250622/inhaled-insulin-safe-effective-for-children-with-diabetes

Inhaled insulin safe, effective for children with diabetes Inhaled insulin is an “important alternative” to injected rapid-acting analog insulin for children and teens with diabetes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5035370/

Improving Efficacy of Inhaled Technosphere Insulin ... Background: Technosphere® insulin (TI), an inhaled human insulin with a fast onset of action, provides a novel option for the control of prandial glucose.

6. investors.mannkindcorp.com investors.mannkindcorp.com/news-releases/news-release-details/mannkind-highlight-data-recent-pediatric-and-adult-studies

Release Details Dr. Haller is the Chair for MannKind's Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age).

7. contemporarypediatrics.com contemporarypediatrics.com/view/michael-haller-md-discusses-inhaled-insulin-and-afrezza-data-for-type-1-diabetes

Michael Haller, MD, discusses inhaled insulin and Afrezza ... Michael Haller, MD, discusses inhaled insulin and Afrezza data for type 1 diabetes ... inhaled insulin is safe and effective in children with T1D.