MannKind has completed the Phase 3 clinical study of Afrezza (insulin human [rDNA origin]) in patients with type 1 diabetes and expects to release the data in the summer of 2013.
Administered using MannKind's next-generation inhaler, the investigational, ultra rapid-acting mealtime insulin therapy is being developed against type 1 or type 2 diabetes to control hyperglycemia.
All patients were optimized on their basal insulin regimen during the run-in period, after which 518 subjects were randomized to one of three arms for mealtime insulin.
Study 171's three arms include a control arm with injected rapid-acting insulin, two Afrezza arms one for MedTone inhaler and the other for the next-generation inhaler.
The primary outcome parameter is assessment of HbA1c levels during an observation period of 12 weeks on stable doses of the mealtime insulin subsequent to titration of the same.
The open-label study will also compare the safety profile of the two Afrezza treatment groups.
