Afrezza + Basal Insulin for Type 1 Diabetes

(INHALE-1st Trial)

Not yet recruiting at 1 trial location

Overseen By Jennifer Pleitez

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Mannkind Corporation

Must be taking: Basal insulin

Disqualifiers: Chronic lung disease, Smoking, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of Afrezza, an inhaled insulin, when combined with basal insulin (a long-acting insulin) for children newly diagnosed with stage 3 type 1 diabetes. The researchers aim to assess how this combination affects blood sugar control and the satisfaction of participants and their families with the treatment. It targets children recently diagnosed with type 1 diabetes who can begin this treatment plan soon after diagnosis, provided they have no chronic lung issues like asthma. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that using Afrezza (inhaled insulin) with basal insulin is generally safe for people with type 1 diabetes. One study found no new safety concerns with Afrezza, indicating it is well-tolerated. Another study demonstrated that inhaled insulin effectively controls blood sugar in children, similar to standard treatments, without new safety issues. Additionally, other research confirms that Afrezza has a known safety record. While any medication can have side effects, extensive studies of Afrezza combined with basal insulin have not revealed unexpected problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Unlike the standard treatments for Type 1 diabetes, which often rely on injected insulin, Afrezza stands out because it is an inhalable insulin. This unique delivery method allows for rapid absorption, meaning it can start working faster to control blood sugar levels compared to traditional insulin injections. Researchers are excited about its potential to provide more convenient and flexible management of blood sugar, especially around meal times, offering a promising alternative for those looking to avoid frequent injections.

What evidence suggests that Afrezza plus basal insulin might be an effective treatment for type 1 diabetes?

Research has shown that Afrezza, an inhaled insulin, helps people with type 1 diabetes control their blood sugar levels. Studies have found that Afrezza effectively manages blood sugar after meals. It performs as well as rapid-acting insulin (RAI) in lowering A1C levels, an important measure of long-term blood sugar control. One study found that Afrezza is safe and effective for children with diabetes, with only a slight increase in HbA1c levels over 26 weeks. This trial will evaluate the combination of Afrezza with basal insulin, which could be a promising option for managing type 1 diabetes in young people when used with long-acting insulin. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

The INHALE-1st trial is for young people aged 10 to under 18 who have recently been diagnosed with stage 3 type 1 diabetes. Participants must be willing to use Afrezza, an inhaled insulin, alongside a long-acting injected basal insulin for at least 13 weeks, with the option to continue up to half a year.

Inclusion Criteria

Forced Expiratory Volume in One Second (FEV1) >80.0% of predicted Global Lung Function Initiative (GLI) value

Investigator believes that participant can be expected to follow the study protocol

I am between 10 and 17 years old.

Exclusion Criteria

Allergy or known hypersensitivity to human regular insulin

Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for smoking

I have taken insulin for stage 2 Type 1 Diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an individualized dose of Afrezza (Technosphere Insulin) and basal insulin before each meal for 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Optional extension phase for participants continuing to use Afrezza in combination with basal insulin

Up to 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Afrezza
• Basal insulin

Trial Overview This Phase 2 study tests the safety and effectiveness of Afrezza (inhaled insulin) combined with a basal insulin injection in managing blood sugar levels in youths with new-onset type 1 diabetes. It also looks into how satisfied patients and their caregivers are with this treatment approach.

How Is the Trial Designed?

Group I: Afrezza (Technosphere Insulin) + Basal Insulin Experimental Treatment 2 Interventions

Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.

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/study-shows-promising-results-inhaled-insulin-treatment-type-1-diabetes

Study Shows Promising Results for Inhaled Insulin as ... Findings Reveal Efficacy of Novel Inhaler to Improve Glycemic Control for Patients with Type 1 Diabetes. Today, findings from INHALE-3, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317946/

Safety and Efficacy of Inhaled Technosphere® Insulin in the ... This study investigated whether a higher modified dose conversion of TI results in greater improvement in postprandial glycemic management ...

3. afrezzahcp.com afrezzahcp.com/efficacy/

Afrezza HCP » Efficacy AFREZZA provided less A1C reduction than RAI, satisfied the non-inferiority margin of 0.4%, and the difference was statistically significant.

4. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/833-P/160214/833-P-Efficacy-and-Safety-of-Prandial-Technosphere

833-P: Efficacy and Safety of Prandial Technosphere Inhaled ... 833-P: Efficacy and Safety of Prandial Technosphere Inhaled Insulin (Afrezza) Compared with Placebo in Adult Individuals with T2DM—Results ...

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

Inhaled insulin safe, effective for children with diabetes The primary outcome was HbA1c at 26 weeks. The technosphere insulin group had an increase in HbA1c from 8.22% at baseline to 8.41% at 26 weeks.

6. diabetesjournals.org diabetesjournals.org/care/article/48/3/353/157574/A-Randomized-Trial-Comparing-Inhaled-Insulin-Plus

A Randomized Trial Comparing Inhaled Insulin Plus Basal ... To evaluate the efficacy and safety of TI, we conducted a randomized controlled trial (RCT) in adults with type 1 diabetes. The trial compared a ...

7. 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 ... The findings indicate that inhaled insulin is safe and effective in children with type 1 diabetes, demonstrating glycemic control comparable to ...

8. afrezzahcp.com afrezzahcp.com/inhale-3-data/

INHALE-3 Data The AFREZZA and AID groups achieved comparable glycemic goals (A1C <7% and TIR >70%). Demonstrated established safety profile.

9. 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 ...