Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial

OBJECTIVE To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS This open-label noninferiority trial compared the change in HbA 1c from baseline to week 24 of prandial TI ( n = 174) with that of subcutaneous aspart ( n = 171), both with basal insulin, in patients with type 1 diabetes and HbA 1c 7.5–10.0% (56.8–86.0 mmol/mol). RESULTS Mean change in HbA 1c in TI patients (–0.21% [–2.3 mmol/mol]) from baseline (7.94% [63.3 mmol/mol]) was noninferior to that in aspart patients (–0.40% [–4.4 mmol/mol]) from baseline (7.92% [63.1 mmol/mol]). The between-group difference was 0.19% (2.1 mmol/mol) (95% CI 0.02–0.36), satisfying the noninferiority margin of 0.4%. However, more aspart patients achieved HbA 1c P = 0.0102). TI patients had a lower hypoglycemia event rate than aspart patients (9.8 vs. 14.0 events/patient-month, P CONCLUSIONS In patients with type 1 diabetes receiving basal insulin, HbA 1c reduction with TI was noninferior to that of aspart, with less hypoglycemia, less weight gain, but increased incidence of cough.