Afrezza non inferior to insulin aspart in Type 1 Diabetes

MannKind Corporation announced positive preliminary results from Study 171, a Phase III clinical study of Afrezza (insulin human [rDNA origin]) Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind�s next-generation (Gen2) inhaler (also known as the Dreamboat inhaler), in patients with Type 1 Diabetes.

Study 171 was an open-label study involving 518 patients with Type 1 Diabetes on basal/bolus insulin therapy. After a four-week run-in period to optimize their basal insulin, patients entered a 24-week treatment period in which they were randomized in one of three ways: -Continuing on subcutaneous insulin aspart in combination with a basal insulin (170 patients); -Switching to Afrezza administered using the Gen2 inhaler in combination with their basal insulin (174 patients); or -Switching to Afrezza administered using the MedTone inhaler in combination with their basal insulin (174 patients).

The treatment period consisted of 12 weeks of prandial insulin optimization with continued basal titration followed by a 12-week period during which subjects maintained stable doses of insulin (prandial and basal). There was also a follow-up visit four weeks after completion of the treatment period. Over the 24-week treatment period of this study, A1c levels decreased comparably in the Afrezza-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The 95% confidence interval (0.02% to 0.36%) of the between-group difference did not exceed the predetermined threshold of 0.40%, thereby establishing non-inferiority between Afrezza-Gen2 and insulin aspart, which was the primary endpoint of the study,