Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naı̈ve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents

TI significantly reduced HbA1c by20.8% (29.0 mmol/mol) from a baseline of 8.3% (66.8 mmol/mol) compared with TP 20.4% (24.6 mmol/mol) (treatment difference 20.4% [95% CI 20.57, 20.23]; P < 0.0001). More TI-treated subjects achieved an HbA1c £7.0% (53.0 mmol/mol) (38% vs. 19%; P = 0.002). Mean fasting plasma glucosewas similarly reduced in both groups. Postprandial hyperglycemia, based on 7-point glucose profiles, was effectively controlled by TI. Mean weight change was 0.5 kg for TI and21.1 kg for the TP group (P < 0.0001). Mild, transient dry coughwas themost common adverse event, occurring similarly in both groups (TI, 23.7%; TP, 19.9%) and led to discontinuation in only 1.1% of TI-treated and 3.4% of TP-treated subjects. There was a small decline in forced expiratory volume in 1 s in both groups, with a slightly larger decline in the group receiving TI (TI, 20.13 L; TP 20.04 L). The difference resolved after treatment discontinuation.