MannKind has completed patient recruitment in two phase three clinical studies of Afrezza (insulin human [rDNA origin]), a novel mealtime insulin therapy.
Afrezza, being developed for the treatment of adult patients with type one or type two diabetes for the control of hyperglycemia, is administered using MannKind’s to-be-marketed next-generation inhaler.
The drug-device combination product consists of Afrezza inhalation powder, pre-metered into single-use cartridges, and an inhaler.
MannKind chairman and chief executive officer Alfred Mann said that both studies are on track to be completed in the second quarter of 2013 and the company expects to report top-line results next summer.
“Our objective is to resubmit the NDA for Afrezza in the third quarter of next year,” Mann added.
The open-label study 171, being conducted in patients with type one diabetes, will randomise at least 471 subjects to one of three arms for mealtime insulin: a control arm, in which patients utilise injected rapid-acting insulin, or one of two Afrezza arms, one for the MedTone inhaler and the other for the next-generation inhaler.
The primary outcome parameter is a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, subsequent to the mealtime insulin titration.
The comparison of the safety profile of the two Afrezza treatment groups is another objective of the study.
Study 175 is designed to assess Afrezza using the next-generation inhaler in patients with type two diabetes whose disease is inadequately controlled on metformin, with or without a second or third oral medication.
The study, which will randomise at least 328 patients to additional treatment with Afrezza or to Technosphere inhalation powder (placebo) following a run-in period, will also have a titration period, followed by a 12-week evaluation period to measure HbA1c levels.