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MannKind Closes Phase 3 Study of AFREZZA for Type 1 Diabetes

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MannKind Corporation (Nasdaq: MNKD) today announced that all follow-up visits have been completed for the patients enrolled in Study 171, a Phase 3 clinical study of AFREZZA^® (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind's next-generation inhaler. MannKind expects to release data from this study later this summer.

Study 171 is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients were optimized on their basal insulin regimen, 518 subjects were randomized to one of three arms for mealtime insulin: a control arm, in which patients utilize injected rapid-acting insulin, or one of two AFREZZA arms, one for the MedTone inhaler and the other for the next-generation inhaler. After the mealtime insulin was titrated, there was a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter. Another objective of this study is to compare the safety profile of the two AFREZZA treatment groups.

Posted-In: News FDA


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