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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.
The other study (study 175) is assessing AFREZZA using the next-generation inhaler in patients with type 2 diabetes whose disease is inadequately controlled on metformin with or without a second or third oral medication. After a run-in period during which the subjects remain on their oral medication, at least 328 patients will be randomized to additional treatment with AFREZZA or to Technosphere® inhalation powder (placebo). The study will also have a titration period, followed by a 12-week evaluation period to assess HbA1c levels.
“Completing patient recruitment is the initial element, and often the lengthiest, in the conduct of large scale Phase 3 clinical trials,” said Alfred Mann, Chairman and Chief Executive Officer. “Both studies are on track to be completed in the second quarter of 2013 and we expect to report top-line results next summer. Our objective is to resubmit the NDA for AFREZZA in the third quarter of next year.”