Positive Phase 3 Results for Insulin Inhalation Powder (Afrezza) in Type 1 Diabetes
Study demonstrates product’s non-inferiority versus insulin aspart (August 14)
Positive preliminary results have been reported from a phase 3 study of Afrezza (insulin human [rDNA origin]) inhalation powder (MannKind Corp.), an investigational, rapid-acting mealtime insulin therapy administered with an inhaler, in patients with type 1 diabetes.
Study 171 was an open-label trial involving 518 patients with type 1 diabetes receiving basal/bolus insulin therapy. After a 4-week run-in period to optimize their basal insulin, the patients entered a 24-week treatment period in which their therapy was randomly assigned 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 4 weeks after completion of the 24-week treatment period.
After 24 weeks of therapy, hemoglobin 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 study’s primary endpoint.
Source: MannKind Corp.; August 14, 2013.