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 evaluated Afrezza against usual care — defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation. It utilized a higher initial conversion dose from mealtime injectable insulin to inhaled insulin.
Investigators for the trial presented the outcomes at the American Diabetes Association Scientific Sessions in Orlando, Florida. The study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group.
More about the MannKind INHALE-3 study
Key sub-analysis findings included that more subjects utilizing inhaled insulin achieved their glycemic targets. Outcomes on that front included:
- 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group.
- 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7%.
- 24% of the Afrezza group and 13% of the usual care group achieved TIR above 70% with no increased hypoglycemia in the inhaled insulin group.
According to a MannKind news release, investigators found no difference in CGM-measured hypoglycemia between the groups. The study also helped establish a titrated basal-bolus ratio of approximately 70/30 inhaled insulin to basal vs. 50/50 for usual care.
While more people met their A1c target with Afrezza, the study saw some subjects worsen when switching from usual care to inhaled insulin. Investigators chalked this up to potentially missing doses of inhaled insulin during the day and/or underdosing going into bedtime.
Additionally, more than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza.
“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,” said Dr. Kevin Kaiserman, SVP, clinical development and medical affairs for MannKind Corporation. “Our data continues to show the importance of Afrezza as a safe and effective tool for managing diabetes.”
