The study followed patients for a total of up to two years. The patients were randomly assigned to a treatment regimen of either AFREZZA plus subcutaneous basal insulin or usual diabetes treatment regimens of any insulin. At the end of two years, there was a comparable reduction in HbA1c levels (by 0.29% and 0.31% in the AFREZZA and usual care groups, respectively). Additionally, AFREZZA resulted in weight loss, while standard diabetes care resulted in weight gain (-0.59 versus +1.38kg, respectively; p=0.0007). There was a lower incidence of hypoglycemic events in the AFREZZA group (61.8% versus 66.05% for the usual care group).
AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder