INHALE-1 Findings Support Inhaled Insulin as a Viable Option for Pediatric Patients: Kevin Kaiserman, MD

Inhaled insulin (Afrezza; MannKind Corporation) continues to build a case for broader adoption in pediatric diabetes care. After its FDA approval for children aged 6 and older in May 2026, new data presented at the 86th Scientific Sessions of the American Diabetes Association (ADA) show the therapy holds up across multiple patient populations. In youth with well-controlled diabetes (HbA1c ≤ 9.5%), the drug matched rapid-acting analogs in mean HbA1c and time-in-range over 26 weeks. Among those who achieved HbA1c below 8%, both adolescents and parents reported statistically greater treatment satisfaction compared with standard therapy.

As the 2026 ADA Standards of Care place greater emphasis on individualized therapy and shared decision-making, inhaled insulin is drawing renewed clinical attention. Kevin Kaiserman, MD, senior vice president and therapeutic area head for diabetes at MannKind Corporation, spoke with The American Journal of Managed Care® about data presented across 9 posters at the meeting, including findings from the INHALE-1 (NCT04974528) pediatric trial and real-world analyses of long-term pulmonary safety.

Kaiserman framed patient selection less as a clinical determination and more as a shared conversation. "It's not really what the clinician necessarily thinks, but actually a conversation with both patient and clinician to determine what's going to work best for them," he said. The 2026 ADA Standards of Care update, which emphasizes individualized therapy and optionality, aligns with that approach.

Kaiserman highlighted several findings consistent across adult and pediatric trials, including stable efficacy and safety data, mealtime dosing flexibility, and the option to administer a correction dose as soon as 60 minutes after the initial dose. He emphasized the drug's rapid pharmacokinetic profile as a key clinical differentiator, noting that the ability to more closely align insulin delivery with food absorption is central to its potential utility in diverse patient populations.

On pulmonary safety in pediatrics specifically, Kaiserman cited what he described as the most notable finding across this year's presentations: no difference in pulmonary function testing between pediatric patients using inhaled insulin and those using subcutaneous insulin in the INHALE-1 trial.

Looking ahead, Kaiserman pointed to the FDA's pediatric review and an ADA poster on inhaled insulin use in gestational diabetes as evidence supporting the therapy's utility across a broad patient spectrum. He suggested the primary obstacle to wider adoption is no longer the volume of data but dissemination, including getting existing evidence in front of clinicians and patients who remain unaware of inhaled insulin as an option.

Reference

Data at ADA 2026 highlights key findings from clinical and real‑world studies of MannKind’s Afrezza (inhaled insulin) across pediatric care, pregnancy, and use with automated insulin delivery (AID) systems. News release. MannKind. June 5, 2026. Accessed June 5, 2026.