MannKind Corporation (MNKD) Completes Patient Recruitment in Two Phase 3 Clinical Studies of AFREZZA
10/5/2012 9:56:44 AM
VALENCIA, Calif.--(BUSINESS WIRE)--MannKind Corporation (Nasdaq: MNKD) today announced that it has completed recruiting patients for two Phase 3 clinical studies of AFREZZA® (insulin human [rDNA origin]), an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s to-be-marketed next-generation inhaler. The first of these studies (study 171) is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients are optimized on their basal insulin regimen, at least 471 subjects are to be 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 is titrated, there is 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.