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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Mealtime Ultra-Rapid Acting Insulin
MODEL Clinical Research
Baltimore, Maryland, United States
Change in Percentage of HbA1c From Baseline to 3 Months
Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower
Time frame: Baseline to 3 months
Percentage of Patients With HbA1c Under 7% at 3 Months
Percentage of patients with uncontrolled type 2 diabetes with HbA1c that is under 7% at 3 months
Time frame: 3 months
Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS
Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes.
Time frame: 3 months
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