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

摘要

OBJECTIVETo compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes.RESEARCH DESIGN AND METHODSThis 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).RESULTSMean 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) <7.0% (53.0 mmol/mol) (30.7% vs. 18.3%). TI patients had a small weight loss (-0.4 kg) compared with a gain (+0.9 kg) for aspart patients (P = 0.0102). TI patients had a lower hypoglycemia event rate than aspart patients (9.8 vs. 14.0 events/patient-month, P < 0.0001). Cough (generally mild) was the most frequent adverse event (31.6% with TI, 2.3% with aspart), leading to discontinuation in 5.7% of patients. Treatment group difference for mean change from baseline in forced expiratory volume in 1 s was small (40 mL) and disappeared upon TI discontinuation.CONCLUSIONSIn patients with type 1 diabetes receiving basal insulin, HbA(1c) reduction with TI was noninferior to that of aspart, with less hypoglycemia and less weight gain but increased incidence of cough.