Afrezza® Dosing Optimization Study

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT04849845

Run by

Mannkind Corporation

People needed

20

Starts

2021-04-09

Expected to finish

2021-05-28

Last updated by the study team

2023-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects ≥18 years of age at the time of signing the informed consent form
• Clinical diagnosis of T1DM or T2DM (per the Investigator) and on a stable basal-bolus insulin regimen

You may not qualify if…

• 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
• History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy)
• On dialysis
• Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
• Treatment with any investigational drug in the past 30 days or an investigational device in the past 2 weeks
• 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
• Use of antiadrenergic drugs (e.g., beta blockers and clonidine)
• Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
• History of a significant eating disorder (e.g., anorexia or bulimia nervosa)
• 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
• History of smoking (includes cigarettes, cigars, pipes, vaping devices, and marijuana) in the 6 months before screening
• 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)
• An event of severe hypoglycemia, as judged by the Investigator, within the 90 days before screening
• An episode of diabetic ketoacidosis (DKA) requiring hospitalization within the 90 days before screening
• Exposure to Afrezza in the 30 days before screening

Where it is running

• AMCR Institute — Escondido, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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