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Insulin

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

Phase 3
Waitlist Available
Research Sponsored by Mannkind Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) per the Investigator and have been using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
Basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
Must not have
An episode of DKA requiring hospitalization within the last 90 days prior to screening
Recent history of asthma (defined as using any medications to treat within the last year), any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights

Summary

This trial is testing the efficacy and safety of Afrezza, a inhaled insulin, in children with type 1 or 2 diabetes. The trial has a screening and run-in period of up to 5 weeks, followed by a 26-week randomized treatment period, during which subjects will receive either Afrezza or a rapid-acting insulin injection. All subjects will then enter a 26-week treatment extension, during which they will receive Afrezza. The trial will conclude with a 4-week follow-up period.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Afrezza may cause coughing, throat pain or irritation when inhaled. Both Afrezza and injected insulins can lead to low blood sugar levels (hypoglycemia), which might be serious. Other possible side effects include weight gain and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have diabetes and have been using insulin for the required time.
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I am using insulin glargine, degludec, or detemir for my diabetes.
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I am between 4 and 17 years old.
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I have been on a basal-bolus insulin regimen with multiple daily injections for at least 2 weeks.
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I only use rapid-acting insulins like lispro, aspart, or glulisine.
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I take 2 or more units of insulin with each meal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was hospitalized for diabetic ketoacidosis within the last 3 months.
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I have asthma or another serious lung or heart condition.
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I am taking medication that affects my adrenaline levels.
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I have serious diabetes complications like vision problems or nerve damage.
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I am under 8 and cannot perform the FVC breathing test properly.
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I am unable or unwilling to follow the study's required procedures.
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All my illnesses except diabetes are under control with stable treatment.
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My lung function tests are below the required levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Fasting Plasma Glucose (FPG)
Event rate of pooled level 2 and level 3 hypoglycemia
Other outcome measures
Change in FPG
Change in HbA1c
Change in percent Time Above Range (glucose >180 mg/dL)
+19 more

Side effects data

From 2020 Phase 2 trial • 30 Patients • NCT02527265
67%
Hypoglycemia
47%
Cough
13%
Dysmenorrhea
7%
Throat irritation
7%
Gastroenteritis
7%
Diabetic ketoacidosis
7%
Constipation
7%
Upper respiratory tract infection
7%
Urine cotinine test positive
7%
Diarrhoea
7%
Arthralgia
7%
Headache
7%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Afrezza Cohort 1 (Ages 13-17)
Afrezza Cohort 2 (Ages 8-12)

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Basal Insulin
2013
Completed Phase 3
~1500
Afrezza
2017
Completed Phase 2
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Type 1 Diabetes involve insulin therapy, which is essential due to the lack of endogenous insulin production in these patients. Rapid-acting insulins, such as those delivered via inhalation like Afrezza, work by quickly entering the bloodstream to manage postprandial blood glucose levels. This rapid onset and short duration of action help to mimic the body's natural insulin response to meals. Inhaled insulin offers a non-invasive alternative to injections, potentially improving adherence and quality of life, especially in pediatric patients, by reducing the burden of multiple daily injections.

Find a Location

Who is running the clinical trial?

Mannkind CorporationLead Sponsor
57 Previous Clinical Trials
7,995 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
154 Previous Clinical Trials
34,780 Total Patients Enrolled
Kevin KaisermanStudy DirectorMannkind Corporation

Media Library

Afrezza (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT04974528 — Phase 3
Type 1 Diabetes Research Study Groups: Afrezza (Technosphere Insulin) + Basal Insulin, RAA Injection + Basal Insulin
Type 1 Diabetes Clinical Trial 2023: Afrezza Highlights & Side Effects. Trial Name: NCT04974528 — Phase 3
Afrezza (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04974528 — Phase 3
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT04974528 — Phase 3
~9 spots leftby Sep 2024