MannKind Corporation announced that the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics met its primary endpoint, with 30% of participants using Afrezza achieving an HbA1c level of less than 7% at 17 weeks compared to 17% of the usual care group. The company, which announced some data from the INHALE-3 trial in March 2024, said that it would present data from Week 30 at future conferences.
Although the Afrezza group included a greater number of people who reduced A1c to less than 7%, the company said that some participants who used the insulin DPI instead of their usual care (automated insulin pumps or multiple injections for most participants) actually increased their A1c levels, possibly due to missed doses. MannKind said that more half of the participants “expressed an interest in continuing to use Afrezza.”
MannKind Senior VP, Clinical Development and Medical Affairs, Kevin Kaiserman said, “INHALE-3 adds to the body of evidence that when combined with basal insulin, inhaled insulin’s effect on HbA1c/TIR is similar to that of the usual care, inclusive of AID pumps, with no new safety concerns. Our data continues to show the importance of Afrezza as a safe and effective tool for managing diabetes.”
Read the MannKind Corporation press release.
