Afrezza: Phase III data

Preliminary data from the open-label, international Phase III AFFINITY 1 trial (Study 171) in 518 Type I diabetics showed that Afrezza administered via MannKind's next-generation Dreamboat inhaler met the primary endpoint of non-inferiority to subcutaneous NovoLog insulin aspart in reducing HbA1c from baseline to week 24 (0.21% vs. 0.40%, 95% CI: 0.02%, 0.36%). The 95% CI of the between-group difference was below 0.40%, the pre-determined threshold for non-inferiority. The proportion of patients achieving HbA1c target levels of <=7% or <=6.5% at 24 weeks was smaller in the Afrezza via Dreamboat group vs. insulin aspart.

On secondary endpoints at 24 weeks, Afrezza via Dreamboat led to a reduction in mean fasting blood glucose of 25.3 mg/dL vs. an increase of 10.2 mg/dL with insulin aspart (p=0.0027). Patients receiving Afrezza via Dreamboat lost an average of 0.39 kg vs. an average gain of 0.93 kg in the injected insulin group (p=0.0102). Furthermore, Afrezza via Dreamboat lowered the rate of severe hypoglycemia vs. insulin aspart (9.8 vs. 13.97 events per subject-month; p<0.0001). Afrezza via Dreamboat non-significantly lowered the rate of severe hypoglycemia vs. insulin aspart (8.05 vs. 14.45 events per 100 subject-months p=0.1022). ...