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     153  0 Kommentare INHALE-3 Study Reveals Positive Readout in Head-to-Head Comparison of Inhaled Insulin vs. Usual Care in T1D; New Data Presented at American Diabetes Association’s 84th Scientific Sessions

    • Study proves inhaled insulin is as effective as usual care (primarily automated insulin delivery pumps or multiple daily injections) for adults living with T1D meeting the primary endpoint
    • Patients utilizing inhaled insulin reached target A1c (less than 7%) 30% of the time compared to 17% with usual care and 24% had time-in-range (TIR) above 70% with no increased hypoglycemia compared with 13% with usual care
    • More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza

    DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 22, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced positive 17-week results from the INHALE-3 study, a Phase 4 U.S. clinical trial evaluating Afrezza (plus basal insulin) vs. usual care (defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation) utilizing a higher initial conversion dose from mealtime injectable insulin to inhaled insulin. The study, which was presented by the INHALE-3 investigational team at the American Diabetes Association’s (ADA) 84th Scientific Sessions in Orlando, met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group.  

    Key sub-analysis findings included:

    • More subjects utilizing inhaled insulin achieved glycemic targets:
      • 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
    • No difference in CGM-measured hypoglycemia between the groups
    • Study helps to establish a titrated basal-bolus ratio that is approximately 70/30 inhaled insulin to basal vs. 50/50 for usual care
    • While more people met the glycemic target of A1c (less than 7%) with Afrezza, some subjects worsened when switching from usual care to inhaled insulin, potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime
    • More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza

    “Inhaled insulin demonstrated improved mealtime control, which is significant given how this continues to be a significant unmet need,” said Dr. Irl Hirsch, Professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington and the INHALE-3 Study Protocol Chair. “The INHALE-3 study delivered data that supports inhaled insulin being an important treatment option for adults living with diabetes.”

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    INHALE-3 Study Reveals Positive Readout in Head-to-Head Comparison of Inhaled Insulin vs. Usual Care in T1D; New Data Presented at American Diabetes Association’s 84th Scientific Sessions Study proves inhaled insulin is as effective as usual care (primarily automated insulin delivery pumps or multiple daily injections) for adults living with T1D meeting the primary endpointPatients utilizing inhaled insulin reached target A1c (less …