MannKind Corporation has announced that it has positive preliminary results from two Phase 3 clinical studies of Afrezza, inhaled ultra rapid-acting mealtime insulin.
The first study 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. During the 24 week study the patients were randomized to one of two groups where, in addition to their oral medication, they received either Afrezza Inhalation Powder, administered using the Gen2 inhaler or Technosphere Inhalation Powder (placebo), administered using the Gen2 inhaler.
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. A significantly greater percentage of patients in the Afrezza group also reached specified A1c target levels than in the comparator oral-therapy group. After 24 weeks of treatment, 37.7% of patients in the Afrezza group achieved A1c levels below 7.0% compared to only 19.0% of patients in the comparator oral-therapy group, and 15.9% of patients in the Afrezza group achieved A1c levels below 6.5% compared to only 4.2% of the patients receiving only oral therapy.
The second study was an open-label study involving 518 type 1 diabetes patients on basal/bolus insulin therapy. During the 24-week treatment period in which patients were randomized in one of three groups. The first continuing on subcutaneous insulin aspart in combination with a basal insulin, the second continued to use their basal insulin but switched to Afrezza administered using the Gen2 inhaler and the third continued to use their basal insulin while switching to Afrezza administered using the MedTone inhaler in combination with their basal insulin.
Over the 24-week treatment period of this study, no significant difference was found between the three groups but there was a significant difference in fasting blood glucose (FBG) levels in the Afrezza Gen2 group compared to the insulin aspart group. In the Afrezza-Gen2 group, mean FBG levels decreased by 25.3 mg/dL by the end of the treatment period whereas the insulin aspart group experienced an increase of 10.2 mg/dL in FBG levels over the same period (p=0.0027). After the four-week follow-up period, during which all patients received insulin aspart and a basal insulin, there was no longer any difference in FBG levels between the treatment groups, demonstrating that this effect on FBG levels was attributable to Afrezza therapy.
There was also significantly less total hypoglycemia in the Afrezza-Gen2 group compared to the insulin aspart group.