Afrezza success in Type 2 Diabetes trial

Study 175 was a double-blind, placebo-controlled study involving 353 patients with Type 2 Diabetes whose disease was inadequately controlled on metformin with or without a second or third oral medication. After a six-week run-in period during which all patients received dietary counselling and initiated blood glucose monitoring while continuing their oral medications, patients entered a 24-week treatment period in which they were randomized to one of two groups where, in addition to their oral medication, they received either: Afrezza Inhalation Powder from Mankind Corporation,, administered using the Gen2 inhaler (177 patients); or Technosphere Inhalation Powder (placebo), administered using the Gen2 inhaler (176 patients). The treatment period consisted of 12 weeks of prandial insulin titration followed by 12 weeks of relatively stable dosing. Subjects could not adjust or alter the doses of their oral medications during the study without discussion between the principal investigator and the medical monitor. There was also a safety follow-up visit four weeks after completion of the treatment period, during which all subjects returned to oral therapy only.

The primary endpoint of the study was the mean change in A1c levels from baseline to week 24 between the two groups. Over the 24-week treatment period, mean A1c levels decreased by 0.82% in the Afrezza group compared to a decrease of 0.42% in the comparator oral-therapy group. The between-group difference in change in mean A1c levels was statistically significant (p<0.0001), thereby establishing the superiority of afrezza over the comparator oral-therapy treatment.>