Total and Severe Hypoglycemia Is Reduced with Use of Inhaled Technosphere Insulin (TI, Afrezza®) Relative to Insulin Aspart in Type 1 Diabetes

Hypoglycemia (HG) and fear of HG limit effective insulin therapy and contribute to suboptimal glycemic control. Ultra-short acting insulins reduce HG risk by providing their glucose-lowering effect early and reducing the risk of late postprandial HG. AFFINITY-1, a treat-to-target study in T1D on multiple daily injection therapy, demonstrated one such ultra-short acting insulin, TI (Afrezza®), was non-inferior to SC aspart in A1C reduction (Bode et al, Diabetes Care 2015). Consistent with its action profile, a lower rate of HG was observed in TI users overall, particularly in the 2-5 h post-meal interval and in those achieving target A1C In this post-hoc analysis of patients with reported A1C values at end of treatment, mean rates for all HG and severe HG obtained from combined SMBG and AE reporting were significantly lower with TI than with aspart (Figure). A negative binomial regression including treatment, region, type of basal insulin, and A1C at end of treatment yielded an LS-mean HG rate for patients on TI 26% lower than comparable patients on aspart across the entire A1C range (mean ratio:0.74, 95% CI: 0.68-0.81). TI’s rapid onset and ultra-short action provide insulin when needed at meals and between meals. This profile improves overall and prandial glucose control and, as demonstrated in AFFINITY-1, has the potential to reduce the risk of late post-meal HG. Disclosure L. Blonde: Other Relationship; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; Lexicon Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Other Relationship; Self; Janssen Scientific Affairs, LLC.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Merck & Co., Inc., Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Other Relationship; Self; Novo Nordisk Inc., Sanofi. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi US. F. Pompilio: Employee; Self; MannKind Corporation. Stock/Shareholder; Self; MannKind Corporation, Amgen Inc. S.R. Bruce: Consultant; Self; MannKind Corporation, Oramed Pharmaceuticals, Inc. M.L. Grant: Employee; Self; MannKind Corporation. Stock/Shareholder; Self; MannKind Corporation. D.M. Kendall: Employee; Self; MannKind Corporation. Employee; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.