Inhaled Insulin Demonstrates Comparable Safety, Lung Function, and Efficacy to Injectable Insulin in Type 1 Diabetes

In the open-label, randomized, phase 3 INHALE-1 clinical trial (NCT04974528), an insulin human inhalation powder (Afrezza; MannKind) demonstrated safe and effective replacement for rapid-acting meal insulin in children with type 1 diabetes (T1D). The study authors, who previously shared their findings at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, said inhaled insulin is safe and effective in this pediatric patient population and demonstrates comparable glycemic control to injected rapid-acting insulin.^1,2

“Inhaled insulin is the fastest-acting insulin available and is a valuable alternative to injected analog insulin. Afrezza should be available as an option to all children and adults with type 1 diabetes,” Michael J. Haller, MD, MS-CI, professor and chief of pediatric endocrinology, University of Florida, and lead author of the study, said in the news release.¹

How Does Afrezza Support Children With Type 1 Diabetes?

As a human-inhaled man-made insulin, Afrezza is indicated to rapidly improve glycemic control in adults with diabetes and recently demonstrated improvements for children with diabetes, providing an additional treatment option for the nearly 304,000 children and adolescents with T1D. These patients typically rely on continuous insulin therapy to manage their blood glucose levels, including daily injections or insulin pumps. However, there is increasing interest in next-generation, personalized treatment options.^1,3

Afrezza is breathed in through the lungs and is administered using a single inhalation per cartridge at the beginning of a meal as an individualized dose, available in 4 units and 8 units. However, the study authors said the medication should not be used as a substitute for long-acting insulin and must be combined with it in patients with T1D.^3,4

Notably, dosage adjustments for Afrezza may be necessary when switching from another insulin, and insulin-naive patients are recommended to start with the 4-unit dose at each meal. Additionally, for patients who previously used subcutaneous mealtime insulin, the appropriate dose should be determined using a conversation table. For those switching from premixed insulin, half of their total daily dose should be divided equally among 3 meals and converted to an Afrezza dose, while the remaining half should be given as basal insulin. However, the dose should be adjusted based on individual metabolic needs, blood glucose results, and treatment goals, considering factors like physical activity, diet, kidney or liver function, and illness.⁴

What Is The Clinical Trial Data Supporting Afrezza’s Use in Children?

The INHALE-1 clinical trial assessed the safety and efficacy of Afrezza among children and adolescents with T1D, including a total of 230 patients aged 4 to 17 years. Researchers used basal injected insulin and randomly assigned inhaled insulin or rapid-acting analogue for meals, evaluating the change in A1c levels at 26 weeks. After completing 26 weeks of randomly assigned treatment with either Afrezza or rapid-acting insulin injections combined with basal insulin, participants continued receiving the inhaled insulin until week 52 for an extension phase to evaluate the safety and effectiveness of Afrezza with continued use.^1,2

Initial results from the pre-extension phase revealed that over the 26-week treatment period, there were no differences in lung function between the Afrezza and multiple daily injections (MDI) treatment groups; Afrezza-treated patients had similar Forced Expiratory Volume in 1 (FEV1) values at baseline and week 26, as did those treated with MDI. Additionally, safety outcomes, including hypoglycemia rates, showed no significant concerns or differences between the 2 groups.⁵

Researchers presented the extension phase results at ADA in their session “Future Ready—Breakthroughs in Pediatric Type 1 Diabetes Care,” highlighting Afrezza’s positive findings among pediatric patients. The results demonstrated that glycemic control with inhaled insulin was like injected rapid-acting insulin and related to less weight gain and higher patient and parent preference scores.¹

“These results will help clinicians better tailor treatment plans, ultimately improving patient satisfaction and overall outcomes,” Haller concluded.¹

REFERENCES

1. Inhaled Insulin Shown as a Safe and Effective Replacement for Standard-of-Care in Children with Type 1 Diabetes. 85th Scientific Sessions of the American Diabetes Association (ADA). News release. June 22, 2025. Accessed October 10, 2025. https://diabetes.org/newsroom/press-releases/inhaled-insulin-shown-safe-and-effective-replacement-standard-care-children

2. Afrezza® INHALE-1 Study in Pediatrics (INHALE-1). National Library of Medicine. Updated May 6, 2025. Accessed October 10, 2025. https://www.clinicaltrials.gov/study/NCT04974528

3. Mayo Clinic. Insulin human inhaled (inhalation route). Updated October 1, 2025. Accessed October 10, 2025. https://www.mayoclinic.org/drugs-supplements/insulin-human-inhaled-inhalation-route/description/drg-20110270

4. AFFREZZA® (insulin human) Inhalation Powder. FDA package insert. Accessed October 10, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf

5. MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza®). Mannkind. News release. December 16, 2024. Accessed October 10, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-six-month-results-phase-3-inhale-1-pediatric