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NEW DELHI, April 16, 2025 – A recent clinical trial suggests that inhaled insulin could offer a viable alternative to injections for managing blood sugar levels in children and adolescents with diabetes, potentially simplifying daily treatment regimens.
MannKind Corporation’s Afrezza Inhalation Powder, an inhaled form of human insulin, demonstrated positive results in the Phase 3 INHALE-1 study, positioning it as a potential future treatment option for pediatric patients aged 4 to 17 with type 1 or type 2 diabetes. Following these findings, MannKind Corporation is preparing to seek approval from the US Food and Drug Administration (FDA) for this expanded use.
The 26-week INHALE-1 study involved 230 participants within the specified age range. Patients were randomly assigned to one of two groups: one receiving pre-meal Afrezza inhaled insulin combined with basal insulin, and the other receiving traditional multiple daily injections (MDI) of rapid-acting insulin analog, also combined with basal insulin.
The primary objective of the trial was to show that the change in average blood sugar levels (measured by ) over 26 weeks in the inhaled insulin group was not worse than (non-inferior to) the change observed in the MDI group. The study successfully met this primary endpoint.
Crucially, the study also monitored lung function, a key consideration for inhaled medications. Results showed no significant differences between the two treatment groups. The average forced expiratory volume in 1 second (FEV1), a standard measure of lung function, remained stable in both groups throughout the 26 weeks.
- Afrezza Group: Baseline FEV1 was liters (99.6% of predicted), and liters (96.6% of predicted) at 26 weeks.
- MDI Group: Baseline FEV1 was liters (102.3% of predicted), and liters (98% of predicted) at 26 weeks.
Researchers concluded that the findings from the six-month study were clinically meaningful. They highlight the potential of Afrezza as a valuable and less invasive future treatment option for children and adolescents managing type 1 or type 2 diabetes. MannKind Corporation intends to request a meeting with the FDA to discuss a supplemental new drug application based on these results.
Disclaimer: This news article is based on information publicly available as of April 16, 2025, primarily from the provided source (Medscape). It is intended for informational purposes only and does not constitute medical advice. Consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.
