Phase 3 Results Announced for Inhalation Form of Insulin
MannKind Corporation announced positive preliminary results from Study 171, a Phase 3 clinical study of Afrezza (insulin human [rDNA origin]) Inhalation Powder in patients with type 1 diabetes administered via the company's Gen2 (Dreamboat) inhaler.
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 basal insulin, patients entered a 24-week treatment period in which they were randomized to either continue on subcutaneous insulin aspart in combination with a basal insulin (170 patients), switch to Afrezza administered using the Gen2 inhaler in combination with their basal insulin (174 patients), or switch 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).
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 (0.02–0.36%) 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. Compared to insulin aspart, Afreeza also demonstrated significantly less hypoglycemia, decreases in fasting blood glucose levels, and a weight advantage.
Afrezza is an investigational ultra rapid-acting mealtime insulin therapy being studied for the treatment of adult patients with type 1 or type 2 diabetes to control hyperglycemia.For more information visit www.mannkindcorp.com.