Improved Postprandial Blood Glucose (PPBG) Excursions with Technosphere Inhaled Insulin (TI) Compared with Aspart in T1D Patients—STAT Study

Abstract

Post-prandial hyperglycemia is difficult to control due to lack of an ideal prandial insulin. TI (Afrezza®) has the most rapid onset of action, lasts for 2 hours. Sixty patients with T1D on multiple daily injections (MDI) were randomized in a multi-center study, stratified by baseline A1c values (<8.5% or ≥ 8.5%) to the control group using aspart (n=34) vs. TI group (n=26). The TI arm was advised to take extra inhalations at 1 and 2 hours after meals based on PPBG. Baseline characteristics were similar (Figure 1a). Forced Expiratory Volume did not differ at all times. We used intent-to-treat analysis, and examined outcomes over a 4-week period using linear regression with repeated measures. Mean CGM glucose, SD, time in range (70-180 mg/dL), % time in hyper- (>180 mg/dL) or hypoglycemia (<70, <60, or <50 mg/dL) were similar in both groups. PPBG at 1 hour was lower in the TI group (mean ± SE PPBG difference -31.7±6.6 mg/dL, p<0.0001). PPBG was numerically lower at 2 hours (mean ± SE PPBG -13.0±7.1 mg/dL, p=0.07) with no difference at 3 and 4 hours (Figure 1b). The TI group increased bolus insulin dose (mean ± SD of 47.8 ± 23.9 U/day) compared to the control group (23.0 ± 9.8 U/day; p<0.0001) in week 1. Bolus insulin dose in the TI group was higher (28.2 U/day; p<0.0001), and did not differ by study week (p=0.25). We conclude that TI improves PPBG when treat-to-target algorithms are used in patients with T1D on MDI. Disclosure H.K. Akturk: None. J.K. Snell-Bergeon: Stock/Shareholder; Self; Abbott. Research Support; Self; Roche Diagnostics Corporation. A. Rewers: None. L.J. Klaff: Research Support; Self; Abbott, Intarcia Therapeutics, Inc., MannKind Corporation, Dexcom, Inc., Novartis Pharmaceuticals Corporation, Gelesis, Novo Nordisk Inc., Eli Lilly and Company, Medtronic, Sanofi. A. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical. Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Eli Lilly and Company, Insulin Algorithms, JDRF, Lexicon Pharmaceuticals, Inc., Livongo Health. Research Support; Self; MannKind Corporation. Other Relationship; Self; Medscape. Advisory Panel; Self; Merck & Co., Inc.. Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc., Omada Health, Inc., Optum Rx, Inc., Sanofi. Research Support; Self; T1D Exchange. Advisory Panel; Self; The Endocrine Society. Research Support; Self; The Leona M. and Harry B. Helmsley Charitable Trust. Advisory Panel; Spouse/Partner; Johnson & Johnson Diabetes Institute, LLC. B.W. Bode: Research Support; Self; Abbott. Advisory Panel; Self; ADOCIA. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Medtronic MiniMed, Inc., Novo Nordisk Inc., Diasome Pharmaceuticals, Inc., Sanofi US, Eli Lilly and Company, MannKind Corporation, Dexcom, Inc., OmniPod, Senseonics. T.S. Bailey: Research Support; Self; Abbott. Consultant; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Ambra BioScience, Ascensia Diabetes Care, Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical. Consultant; Self; Calibra Medical. Research Support; Self; Companion Medical, Dexcom, Inc., Glooko, Inc., GlySens Incorporated, Lexicon Pharmaceuticals, Inc., Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; Medtronic MiniMed, Inc.. Consultant; Self; Medtronic MiniMed, Inc.. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Senseonics. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Versartis, Inc., Xeris Pharmaceuticals, Inc., MannKind Corporation. S.K. Garg: Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Sanofi US. Advisory Panel; Self; Sanofi US. Research Support; Self; MannKind Corporation, Diasome Pharmaceuticals, Inc., Labstyle Innovations, Lexicon Pharmaceuticals, Inc., Medtronic. Advisory Panel; Self; Novo Nordisk A/S.