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Study finds MannKind inhaled insulin safe, effective for children

June 22, 2025 By Sean Whooley

MannKind afrezza inhaled insulin in use
A person uses Afrezza inhaled insulin powder. [Image courtesy of MannKind]
New study results demonstrated the safety and efficacy of the MannKind Afrezza inhaled insulin offering for children with type 1 diabetes.

Investigators presented findings from the INHALE-1 study as a symposium at the American Diabetes Association’s 85th Scientific Sessions. The data showed that inhaled insulin offers a safe and effective replacement for rapid-acting meal insulin in children with type 1.

INHALE-1 evaluated the Afrezza insulin regimen in 230 patients between age 4-17 using basal injected insulin. It randomized subjects to either inhaled insulin or rapid-acting analogue for meals, according to an ADA news release. The study had a primary endpoint of the change in A1C at 26 weeks.

Findings indicate that inhaled insulin delivers glycemic control comparable to injected rapid-acting insulin. Inhaled insulin was also associated with less weight gain and slightly higher patient and parent preference scores. These findings add to outcomes shared from INHALE 1 late last year.

Based on the findings of the inhaled insulin study, MannKind looks to seek FDA approval to expand Afrezza’s indication to children. The company also aims to evaluate inhaled insulin at diagnosis and in automated insulin delivery systems in additional studies.

“Inhaled insulin is the fastest acting insulin available and is a valuable alternative to injected analogue insulin. Afrezza should be available as an option to all children and adults with type 1 diabetes,” said Dr. Michael J. Haller, professor and chief of pediatric endocrinology, University of Florida, and lead author of the study. “These results will help clinicians better tailor treatment plans, ultimately improving patient satisfaction and overall outcomes.”

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations Tagged With: ADA 2025, mannkind

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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