MannKind said that Afrezza inhalation powder is a well-tolerated, ultra rapid acting insulin, provide glucose control similar to standard insulin therapy along with weight loss and reduced incidence of hypoglycemia in patients with type 1 diabetes and poorly controlled blood sugar levels.
MannKind claimed that Afrezza is a drug-device combination product, consisting of Afrezza Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use Afrezza Inhaler. Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the blood stream.
Findings from a prospective, multisite parallel-group study comparing the efficacy and safety of Afrezza versus usual diabetes care in patients with diabetes mellitus and inadequate glycemic control (HbA1c >6.6% and <12.0%) despite subcutaneous insulin therapy were evaluated based on prespecified secondary safety endpoints.
Endpoints included change in HbA1c, change in body weight and frequency of defined mild, moderate and severe hypoglycemia. Patients were followed for a total of up to two years and were randomly assigned to a treatment regimen of either Afrezza plus subcutaneous basal insulin or usual diabetes treatment regimens of any insulin.
Reportedly, of the 538 type 1 patients in the study, 267 subjects received Afrezza along with subcutaneous basal insulin and 271 subjects received usual antidiabetic regimen.
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). There was a lower incidence of hypoglycemic events in the Afrezza group (61.8% versus 66.05% for the usual care group).
Philip Raskin, Clifton and Betsy Robinson chair in Biomedical Research of southwestern medical school at University of Texas, said: “Standard mealtime insulin therapies are effective in managing blood sugars in patients with type 1 diabetes, but are known to cause weight gain and severely low blood sugar levels.
“Our study shows that treatment regimens incorporating Afrezza offer glycemic control comparable to conventional regimens, with the added benefits of weight loss and less incidence of hypoglycemia, making Afrezza a potentially important and useful new treatment option in the diabetes space.”