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The INHALE-1 study is a 26-week, open-label clinical trial that randomized 230 subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing.

Results were as follows: * mITT analysis excludes one outlier from the primary ITT endpoint who failed to adhere to the study protocol An analysis of the full intent-to-treat population (ITT) found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol.



A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study.

Over 26 weeks of treatment, no difference in lung function parameters were seen between the treatment groups. The Afrezza-treated patients had a mean FEV1 of 2.901 liters (99.

6% of predicted) at baseline and 2.934 liters (96.6% of predicted) at 26 weeks.

MDI-treated patients had corresponding mean FEV1 values of 2.948 liters (102.3% of predicted) and 2.

957 liters (98% of predicted), respectively. Additional safety findings, including f.

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