MannKind Corporation reported positive results from its Phase 3 trial of Afresa (insulin human [rDNA origin]) inhalation powder evaluating its effects on glycemic control and pulmonary function over a four-year period in patients with type 2 diabetes. Results from the Phase 3, open-label, controlled study conducted in patients who had previously completed two Phase 2, three-month, randomized clinical trials and continued open-label Afresa as their exclusive prandial insulin regimen showed that patients treated with Afresa therapy experienced glycemic control for at least four years. Mean A1C levels were 7.97% at baseline and remained steady with a slight decline through month 48 (6.45%).
Additionally, the study showed minimal mean change in forced expiratory volume in one second (FEV1) over a four-year period for those treated with Afresa. Annualized change in FEV1 was -0.048 ± 0.006 liters/year, and in diffusing capacity of the lung for carbon monoxide was -0.332 ± 0.085 mL/min/mmHg after four years of Afresa therapy.
Afresa is a novel, ultra rapid acting mealtime insulin therapy being studied for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia.
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