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To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index hemoglobin A1c (HbA1c) between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1c's. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
MODEL Clinical Research
Baltimore, Maryland, United States
Start Date
October 16, 2017
Primary Completion Date
June 10, 2020
Completion Date
June 10, 2020
Last Updated
June 26, 2024
20
ACTUAL participants
Afrezza Inhalant Product
DRUG
Lead Sponsor
Model Clinical Research LLC
Collaborators
NCT04564391
NCT03851627
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