MannKind Enrolls The First Patient In INHALE-1ST Clinical Study Evaluating Afrezza (Insulin Human) Inhalation Powder Shortly After Type 1 Diabetes Diagnosis In Pediatric Patients

INHALE-1ST is designed to assess the safety and efficacy of Afrezza used in combination with subcutaneously injected basal insulin once-daily in youth aged 10 to <18 years newly diagnosed with type 1 diabetes. The study will examine clinical outcomes as well as participant and caregiver satisfaction with use of Afrezza for management of mealtime glucose early in the course of treatment.

The first patient was enrolled at the Barbara Davis Center for Diabetes in Aurora, Colorado, one of about 10 clinical sites participating in the study of approximately 100 patients across the United States.

"Many of the innovations that transformed diabetes care—such as continuous glucose monitors (CGMs) and insulin pumps—proved their full value and impact once they became available to pediatric patients," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "With nearly a decade of safety and real-world adult experience behind Afrezza, INHALE-1ST gives us an important opportunity to assess use earlier in the treatment journey for youth at the time of diagnosis so patients can potentially improve management of their mealtime glucose."

The single-arm, multi-center, clinical study will follow participants for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with basal insulin for up to 26 weeks. The primary endpoint is the percentage of participants with a Continuous Glucose Meter (CGM)-who measured time in range (TIR) 70-180 mg/dL ≥70% during 14 days prior to the 13-week visit.