MannKind Corporation announced that it recently presented initial data from a meal challenge that was part of the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics. Afrezza was approved by the FDA for the treatment of Type 1 and Type 2 diabetes in adults in 2014. The company said that it will present results for the primary endpoint, change in HbA1c from baseline to 17 weeks, at the upcoming American Diabetes Association’s 84th Scientific Sessions.
The recently presented data from the INHALE-3 trial show a 20% reduction in hyperglycemia after meals for patients using Afrezza compared to patients using multiple daily injections or an insulin pump. The Afrezza group also had a decrease of 22% in mean glucose excursions compared to the standard of care group.
MannKind Senior VP, Clinical Development and Medical Affairs, Kevin Kaiserman commented, “One of the challenges of inhaled insulin adoption has been under-dosing when converting from injectable insulin, which causes patients to experience hyperglycemia. In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
Read the MannKind Corporation press release.
