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Inhaled Insulin Dosing in a Randomized Trial in Adults With Type 1 Diabetes
Jennifer Rittenberry1, Joseph Sylvan1, Leah-Elena Mycue1
1MannKind Corporation, Westlake Village, California.
Objective:
Technosphere insulin (TI) is an ultrarapid-acting inhaled insulin available in 4, 8, and 12 U cartridges. The U.S. Prescribing Information recommends converting subcutaneous rapid-acting insulin analogs (RAAs) to TI by rounding up to the nearest 4-U increment. This study aimed to evaluate TI dosing patterns after initiating therapy at a higher conversion dose than in the U.S. Prescribing Information and characterize subsequent titration needs.
Methods:
In a multicenter, randomized trial, adults with type 1 diabetes were assigned to TI plus insulin degludec or usual care. TI was initiated at a 2:1 TI-to-RAA unit conversion, rounded down to the nearest cartridge and titrated to glycemic targets. Dosing data were collected at baseline, 17 weeks, and 30 weeks.
Results:
Across participants randomized to TI with no missing dosing data for 30 weeks (N = 35), mean total daily TI dose increased from 36 U at baseline to 48 U at 17 weeks (P = .002) and 52 U at 30 weeks (P < .001). By 30 weeks, the TI bolus/basal ratio shifted from ∼50%/50% prestudy RAA to ∼70%/30% TI (P < .001). At 17 weeks, 57% of participants increased their TI dose by >4 U; this increased to 74% at 30 weeks. No new safety signals were identified.
Conclusion:
Most participants who initiated TI at a higher conversion dose still required additional TI uptitration for glucose management. This study highlights the need for higher TI unit dosing requirements in clinical practice to support individualized titration to reach glycemic goals.
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