Today, MannKind announced it has finalized the recruitment of patients for two Phase 3 clinical studies of AFREZZA (insulin human [rDNA origin]), which is an investigational, ultra rapid-acting mealtime insulin therapy administered through the company's soon-to-be-marketed next-generation inhaler.
Study 171, the first of the two studies, is an open-label study in patients with type 1 diabetes. Following a run-in period, in which all patients will be optimized on their basal insulin regimens, at least 471 subjects will be randomized to one of three arms for mealtime insulin: a control arm, in which patients use injection rapid-acting insulin; or one of two AFREZZA arms - one for the MedTone inhaler and the other for the next-generation inhaler. Once mealtime insulin is titrated, there will be a 12-week observation period on stable doses of the mealtime insulin in order to assess HbA1c levels, which is the main outcome parameter. Another of the study's objectives is comparing the safety profile of the AFREZZA treatment groups.
Study 175, the second study, will assess AFREZZA using the next-generation inhaler in patients who have type 2 diabetes that is inadequately controlled on metformin, with or without a second or third oral medication. Following a run-in period in which subjects will remain on their oral medications, at least 328 patients will be randomized to additional treatment with AFREZZA or to Technosphere inhalation powder (placebo). This study will additionally have a titration period followed by a 12-week evaluation period to assess HbA1c levels.
Now that patient recruitment - the initial and often lengthiest element in conducting a large-scale Phase 3 clinical trial - is completed, both studies are on track to be completed in the second quarter of 2013. Topline results are expected next summer. After that, the company's objective is to resubmit the NDA for AFREZZA in the third quarter of 2013.
MannKind is a biopharmaceutical company engaged in the discovery, development, and commercialization of therapeutic products for patients with diseases like diabetes and cancer. The company's lead product, AFREZZA, is in late-stage clinical investigation for treating adults with type 1 or type 2 diabetes for the control of hyperglycemia.
For more information on the company, visit www.mannkindcorp.com
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