Inhaled Insulin for Diabetes in Children

(INHALE-1 Trial)

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

319 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 2 3 7 9}

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.

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.

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. United States pubmed.ncbi.nlm.nih.gov

Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion: a randomized study in type 1 diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients with type 2 diabetes. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro mix25 and insulin lispro mix50. Mix50 Study Group. [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Faster aspart insulin (FIASP®)]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Biphasic insulin aspart 30: literature review of adverse events associated with treatment. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of preprandial or postprandial Humalog Mix75/25 versus glyburide in patients 60 to 80 years of age with type 2 diabetes mellitus. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on insulin aspart in type 1 and 2 diabetes mellitus. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Time-action profile and patient assessment of inhaled insulin via the Exubera device in comparison with subcutaneously injected insulin aspart via the FlexPen device. [2013]