Rapid-acting inhaled (Afrezza) and injected mealtime insulins are available for patients with type 2 diabetes who are also treated with basal insulin. In this interim analysis of a single-site, observational, investigator initiated study, time spent in glycemic goal range (70-180 mg/dL) without significant hypoglycemia (primary endpoint) was assessed in the intent-to-treat population of patients with type 2 diabetes (N=25; 60%M; age 62y; wt 95.7±4.4kg; A1c 8.3±0.2%). Patients were titrated from pre-meal insulin plus basal insulin to inhaled insulin plus basal insulin over 2 weeks and followed for 14 weeks. At Week 14, mean (±SE) times spent above (>180 mg/dL; -1.7±3.2 mins; P=0.60), in (70 180 mg/dL; -1.2±2.6 mins; P=0.65), and below (<70 mg/dL; +2.9±2.5 mins; P=0.26) glycemic goal range were not significantly different from baseline. However, A1c significantly decreased from baseline at Week 14 (-0.76%±0.18; P=0.0002). At Week 14, Quality of Life (QoL) Total score did not significantly change from baseline (+0.19±0.13; P=0.15). However, Useful (+0.46±0.20; P=0.03), Freeing (+0.92±0.24; P=0.0008), and Difficult ( 0.68±0.28; P=0.02) QoL subdomains significantly improved from baseline at Week 14. There were no deaths, no serious hypoglycemic events, but 4 patients discontinued (3 upper respiratory tract, 1 diarrhea). Five patients experienced cough, 2 patients chest mucus/congestion, and 2 patients cough/chest congestion. Most upper respiratory events were associated with use of >60 units/day inhaled insulin. Although this interim analysis did not achieve its primary endpoint of significant increase of time spent in glycemic goal range, possibly caused by patients not self-adjusting post-prandial dosing as instructed. Patients treated with inhaled insulin with background basal insulin for 14 weeks experienced significant reduction of A1c and significant improvements of Useful, Freeing, and Difficult QoL subdomains compared to baseline.
M. Kipnes: None. A. Salhin: None. T. Ryan: None. J. Vadakekalam: None. V. Pamar: None. F. Trigoso: None. F. Akhrass: None.