MannKind announced top-level 30-week results from its Phase 4 INHALE-3 study comparing inhaled insulin to traditional delivery methods.
The Danbury, Connecticut-based company designed Afrezza, a rapid-acting inhaled human insulin, to improve glycemic control in adults with type 1 diabetes mellitus. The INHALE-3 study looks at Afrezza against usual care.
Mannkind defines usual care as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation. The study utilized a higher initial conversion dose from mealtime injectable insulin to inhaled insulin.
Results showed that additional participants with type 1 diabetes achieved target A1c levels during the extension Phase. The computer analysis included all people on inhaled insulin, evaluated in two separate groups. One utilized Afrezza (plus basal insulin) over 30 weeks. The other switched to Affreza at week 17 from usual care.
MannKind reported continued improvement in the Afrezza (plus degludec)-treated group. Subjects in that group achieved A1c less than 7% at 30 weeks, marking a 100% increase from baseline. Switching from usual care Afrezza at week 17 allowed more subjects to achieve that level of A1c at week 30 compared to the number at week 17.
“The data from the extension phase of this study showed that more people living with T1D are able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care – whether they are using multiple daily injections or pumps,” said Michael Castagna, CEO for MannKind. “We believe this data demonstrates to healthcare practitioners that Afrezza is an effective tool for their patients who want to improve their glycemic control.”