Pediatric Endocrinologist Discusses INHALE-1 Study and the Approval of Afrezza in Kids
Drs. Steve Edelman and Jeremy Pettus talk with pediatric endocrinologist Dr. Jamie Wood about the INHALE-1 study, from trial design to efficacy and safety results.
Drs. Steve Edelman and Jeremy Pettus, adult endocrinologists with type 1 diabetes (T1D), in conversation with Dr. Jamie Wood, pediatric endocrinologist and INHALE-1 investigator.
Mealtime bolusing remains one of the most stubborn gaps in pediatric type 1 diabetes (T1D) management, and data has long pointed to adolescents and young adults as the group struggling the most to reach A1C targets. The barriers include needle aversion, the social stigma of dosing in front of peers, and during sports and social events. In addition there is a narrow pre-meal timing window that a school day rarely accommodates. With a pediatric indication now extending inhaled rapid-acting insulin down to age six, prescribers have a new option to weigh to help their pediatric patients better manage their diabetes throughout the day. In this episode, an INHALE-1 trial investigator walks us through the study design, which includes the titration approach from subcutaneous insulin, the primary endpoints and the pulmonary safety data.
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Hear from Dr. Edelman on how Afrezza can help your pediatric patients!
INHALE-1 STUDY STATS
~230 participants
Ages 4 to 17 were recruited for the pediatric Inhale-1 trial, with 50% randomized to inhaled insulin and the other half stayed on the multiple daily injections (MDI).
After 26 Weeks
The children who were in the MDI group switched to the inhaled insulin and the study was extended to 52 weeks.
Non-inferiority in A1C
Reported when the rapid-acting injected insulin group was compared to the MDI control group (A modified intention to treat analysis (MITT).
Lower weight gain and BMI increase
In the inhaled-insulin group, a statistically significant difference sustained through 52 weeks.
FEV1 pulmonary function tests
Were unchanged and comparable in both arms. Enrollment required a normal baseline FEV1 and excluded subjects with a history of asthma, smoking, vaping, or significant secondhand-smoke exposure.
17% reported
A dry transient, mild cough as the most common adverse event.
FACTS About The Topic
- Appropriate timing of the pre-meal insulin dose is an unmet need in pediatric T1D. Optimal pre-bolusing of injected rapid-acting insulin is 10 to 20 minutes before the meal, which is often difficult to do for any person taking mealtime insulin, and is not feasible within a 20-minute school lunch period.
- Set-dose cartridges shift the dosing conversation. Fixed increments can allow for small, medium, and large meal dosing rather than carb counting, which some patients find liberating.
- Unit-for-unit conversion does not apply. Cumulative adult and pediatric experience points to roughly a 2:1 conversion to subcutaneous insulin, and sometimes 3:1
- Pulmonary monitoring at baseline and at periodic times is important to monitor safety.
- The rapid-on, rapid-off profile will help around activity and post-meal excursions. Specialists are interested in reduced insulin-on-board ahead of exercise like after school sports leading to less delayed hypoglycemia.
- Inhaled insulin can be used as an additive tool, not a full switch. Many anticipate mix-and-match use in practice, including inhaled insulin for corrections, select meals, or as an adjunct alongside automated insulin delivery (AID).
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