MannKind Corporation announced initial meal challenge data from INHALE-3 that was presented by Dr. Irl B. Hirsch at the 17thInternational Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 8th. INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) 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 (RAA) delivered by MDI or pumps Area under the curve (AUC; 180 mg/dL) 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 patients (123 randomized), 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 (mealtime and corrections). 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 (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal.

Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.