Status:
COMPLETED
Afrezza® Dosing Optimization Study
Lead Sponsor:
Mannkind Corporation
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 (...
Detailed Description
Screening (Visit 1): Informed consent and California Experimental Subjects Bill of Rights will be signed and eligibility confirmed. Eligible subjects will be enrolled at Visit 1. Subjects will come i...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04849845
Start Date
April 9 2021
End Date
May 28 2021
Last Update
September 18 2023
Active Locations (2)
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1
AMCR Institute
Escondido, California, United States, 92025
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598