Afrezza® Dosing Optimization Study
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Afrezza Dose 1; Afrezza Dose 2
Intervention description: The first dose of Afrezza will be based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.; The second dose of Afrezza will be based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Afrezza; Dosing; Technosphere; Inhaled; Insulin; Diabetes

Summary:

      MKC-TI-191 is a Phase 4, single-arm, multicenter, proof-of-concept clinical trial evaluating
      the efficacy and safety of Afrezza, administered according to the current Afrezza prescribing
      information (PI) compared to a titrated dose, in combination with a basal insulin in adult
      subjects (≥18 years of age) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus
      (T2DM). Eligible subjects will be on a stable regimen consisting of a basal bolus insulin
      therapy prior to screening. The study is composed of up to 4 clinic visits (screening, 2
      treatment visits, and a follow-up visit). Two individual doses of Afrezza will be
      administered during a meal challenge at Visits 2 and 3. The duration of each subject's
      participation in the trial is expected to be approximately 2 weeks.
    

Eligibility criteria:

        Subjects will be asked to provide a recent negative COVID-19 test (if available), confirm
        they have no symptoms of COVID-19, or provide evidence of COVID-19 vaccination.

        Inclusion Criteria:

          1. Subjects ≥18 years of age at the time of signing the informed consent form

          2. Clinical diagnosis of T1DM or T2DM (per the Investigator) and on a stable basal-bolus
             insulin regimen

        Exclusion Criteria:

          1. History of asthma, chronic obstructive pulmonary disease, or any other clinically
             important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia), use
             of any medications to treat such conditions within the last year, or significant
             congenital or acquired cardiopulmonary disease

          2. History of serious complications of diabetes (e.g., active proliferative retinopathy
             or symptomatic autonomic neuropathy)

          3. On dialysis

          4. Respiratory tract infection within 14 days before screening (subject may return 14
             days after resolution of symptoms for rescreening)

          5. Treatment with any investigational drug in the past 30 days or an investigational
             device in the past 2 weeks

          6. Any disease other than diabetes or initiation of any new medication that, in the
             judgment of the Investigator, could have a direct impact on glycemic control during
             the study

          7. Use of antiadrenergic drugs (e.g., beta blockers and clonidine)

          8. Any concurrent illness (other than diabetes mellitus) not controlled by a stable
             therapeutic regimen

          9. History of a significant eating disorder (e.g., anorexia or bulimia nervosa)

         10. Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the
             opinion of the Investigator or the Sponsor, would make the subject an unsuitable
             candidate for participation in the study

         11. History of smoking (includes cigarettes, cigars, pipes, vaping devices, and marijuana)
             in the 6 months before screening

         12. Female subject who is pregnant, breastfeeding, intends to become pregnant, or is of
             child-bearing potential and not using adequate contraceptive methods as required by
             local regulation or practice (may include sexual abstinence)

         13. An event of severe hypoglycemia, as judged by the Investigator, within the 90 days
             before screening

         14. An episode of diabetic ketoacidosis (DKA) requiring hospitalization within the 90 days
             before screening

         15. Exposure to Afrezza in the 30 days before screening