MannKind announces initial meal challenge data from INHALE-3 study

MannKind Corporation announced initial meal challenge data from INHALE-3 that was presented by Dr. Irl B. Hirsch at the 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence on March 8th. INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin vs. standard of care. The statistically significant findings included: Subjects utilizing inhaled insulin experienced significantly reduced post-meal hyperglycemia, compared with those who used subcutaneous rapid-acting analogues delivered by MDI or pumps; Area under the curve was reduced by 20%; Inhaled insulin subjects demonstrated significantly lower glucose excursions from baseline; Mean glucose excursions were reduced by 22%; In the inhaled insulin group, mean glucose levels peaked 15 minutes sooner than in the standard of care group despite inhaled insulin being given at start of the meal vs. RAA being administered 5-15 minutes prior to the meal. The 17-week endpoint results from INHALE-3 will be presented Saturday, June 22, during a symposium at the American Diabetes Association’s 84th Scientific Sessions in Orlando. INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study, which enrolled 141 patient, assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses. Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label. Both arms utilized continuous glucose monitoring to assess glucose control. A1c levels were obtained at baseline, 17 and 30-weeks. For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal whereas those using usual care used RAA 5-15 minutes prior to the meal.