A 13-Week Single-Arm Evaluation of Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes

Abstract

Background: Inhaled technosphere insulin (TI, Afrezza®) has a more rapid onset of action than rapid-acting insulin analogs (RAA). Methods: Forty-nine adults with type 1 diabetes (T1D) initiated a regimen of TI plus insulin degludec for 13 weeks after completing 17 weeks in the usual-care control group of a randomized trial. The initial TI dose, based on bioequivalence, was approximately two times the RAA dose being used. The primary outcome was noninferiority for daytime time-in-range (TIR) 70-180 mg/dL at 13 weeks. Results: During the preceding 17-week period (baseline), 41% of the 49 participants were using automated insulin delivery (AID), 6% a predictive-low-glucose-suspend pump, 4% a sensor-augmented pump (SAP), and 49% multiple daily injections (MDI) plus continuous glucose monitoring. Daytime TIR increased from 50% ± 17% at baseline to 55% ± 20% after 13 weeks (mean change 5.1%, 95% confidence interval [CI]: 0.3% to 9.8%, noninferiority P < 0.001, superiority P = 0.04), with an increase of 8.6% compared with baseline MDI/SAP and no change compared with baseline AID. Mean HbA1c change from baseline was -0.23% (95% CI: -0.42% to -0.04%, noninferiority P < 0.001, superiority P = 0.02), with mean change of -0.36% compared with MDI/SAP and 0.0% compared with AID. Participants meeting the HbA1c target of <7.0% increased from 14% to 31% (P = 0.02). Among baseline AID users, overnight TIR decreased by 15.6% when switched to TI-degludec, whereas among baseline MDI/SAP users, overnight TIR increased by 2.0%. Mean time <54 mg/dL was 0.5% ± 0.7% at baseline and 0.7% ± 0.8% after 13 weeks (mean change 0.2%, 95% CI: -0.1% to 0.5%). After 13 weeks, 40% of participants indicated a desire to continue using TI. Conclusions: In adults with T1D, glycemic outcomes were comparable or slightly better with TI-degludec after switching from AID or MDI. TI should be considered as an option for individuals who want an alternative to using an insulin pump or MDI for insulin delivery.

Keywords: adults; hyperglycemia; inhaled insulin; postprandial.