Inhaled Insulin Afrezza Shows Promise for Children with Diabetes

      Inhaled insulin represents a breakthrough in diabetes management, offering a less invasive alternative to traditional injections. The Phase 3 INHALE-1 trial has now provided promising evidence supporting the use of Afrezza, an inhaled insulin, in pediatric patients with type 1 or type 2 diabetes.

      This open-label, randomized clinical trial compared Afrezza combined with basal insulin to multiple daily injections of rapid-acting insulin analogs (insulin aspart, lispro, or glulisine) over 26 weeks. The study included 230 children and adolescents aged 4 to 18 years.

      Results demonstrated that Afrezza achieved non-inferiority to multiple daily injections in reducing HbA1c levels from baseline to week 26. The difference in mean HbA1c change between the two groups stayed within the pre-specified non-inferiority margin of 0.4%. Importantly, no new safety concerns were identified with Afrezza compared to traditional rapid-acting insulin analogs.

      Initially approved by the FDA in 2014 for adults, Afrezza offers a promising alternative for pediatric diabetes care. Mannkind, the manufacturer, is conducting a 26-week extension phase of the trial, switching remaining participants on injection therapy to Afrezza to further evaluate its long-term safety and efficacy.

      These findings underline the potential of inhaled insulin to transform diabetes management in children, simplifying treatment and enhancing quality of life.