What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common side effects of rapid-acting insulins, including inhaled insulin like Afrezza, include hypoglycemia (low blood sugar), cough, throat pain or irritation, and potential lung function decline. Other side effects may include weight gain, headache, and allergic reactions at the injection or inhalation site. It is important for patients to monitor their blood glucose levels regularly and discuss any adverse effects with their healthcare provider.

What prior FDA approvals exist?

Afrezza is an FDA-approved rapid-acting inhaled insulin used to manage blood sugar levels in individuals with diabetes. It is unique in its delivery method, as it is inhaled rather than injected. Other FDA-approved rapid-acting insulins include insulin aspart, insulin lispro, and insulin glulisine, which are typically administered via injection. These insulins are used in combination with basal insulin to provide comprehensive blood sugar control. While Afrezza offers an alternative for those who prefer not to use injections, it is important to discuss with a healthcare provider to determine the most appropriate treatment plan.

What other types of research exist?

Promising novel alternatives to Afrezza for Type 1 Diabetes patients in 2024 include: 1) Faster-acting insulin aspart (Fiasp), which has a quicker onset of action compared to traditional insulin aspart. 2) Ultra-rapid lispro (URLi), designed to provide faster absorption and action. 3) Closed-loop insulin delivery systems (artificial pancreas), which automate insulin delivery based on continuous glucose monitoring. These alternatives offer improved glycemic control and convenience.

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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

Pivotal Trial

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Fasting Plasma Glucose (FPG)

Event rate of pooled level 2 and level 3 hypoglycemia

Other study objectives

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

Headache

Diabetic ketoacidosis

Gastroenteritis

Throat irritation

Constipation

Arthralgia

Urine cotinine test positive

Upper respiratory tract infection

Diarrhoea

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Afrezza Cohort 1 (Ages 13-17)

Afrezza Cohort 2 (Ages 8-12)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 4

~1640

Afrezza

2023

Completed Phase 4

~180

0 / 14Eligibility criteria met

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.