INHALE-1: A Multicenter Randomized Trial of Inhaled Technosphere Insulin in Children With Type 1 Diabetes

Area of Science:

• Pediatric Endocrinology
• Diabetes Management
• Pharmacology

Background:

• Type 1 diabetes is a chronic condition requiring lifelong insulin therapy.
• Optimizing insulin delivery methods is crucial for improving glycemic control and patient quality of life.
• Inhaled insulin presents a potential alternative to injectable insulin formulations.

Purpose of the Study:

• To assess the efficacy and safety of inhaled technosphere insulin (TI) compared to rapid-acting analog (RAA) insulin in pediatric patients with diabetes.
• To evaluate TI's impact on glycemic control, specifically HbA1c levels and time in range (TIR).
• To determine the safety profile of TI, including pulmonary function and adverse events.

Main Methods:

• A randomized controlled trial involving 230 youth (4-17 years) with type 1 diabetes.
• Participants were assigned to receive either TI or RAA insulin for 26 weeks, alongside basal insulin and continuous glucose monitoring (CGM).
• The primary outcome was the change in HbA1c, with noninferiority testing against a 0.4% margin.

Main Results:

• The primary analysis did not achieve noninferiority for HbA1c change between TI and RAA groups (P = 0.091).
• CGM-measured time in range (70-180 mg/dL) showed no significant difference between the groups (P = 0.38).
• The TI group reported higher treatment satisfaction (P = 0.004) and experienced less weight and BMI percentile gain (P = 0.009).

Conclusions:

• Inhaled technosphere insulin did not meet the noninferiority criteria for HbA1c in pediatric patients with diabetes.
• TI demonstrated a favorable safety profile over 26 weeks, with no adverse effects on pulmonary function.
• TI offers a potentially valuable treatment option for select pediatric patients with type 1 diabetes, enhancing satisfaction and mitigating weight gain.