Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

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 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 HbA1cs. 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.

Inclusion Criteria:

- Adult type 2 diabetes patients age 18 or older

- HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication.
Treatment may include oral agents, basal insulin or GLP-1 in any combination.

- Patient and provider agree not to add additional diabetes medications during the 14
weeks of the study (unless rescue treatment is indicated).

Exclusion Criteria:

- History of asthma, COPD or smoking within 6 months

- FEV1 under 70% predicted

- Pregnancy

- Active malignancies and/or life expectancy of < 12 months

- Major surgery planned during study period

- Currently using rapid acting insulins - Novolog, Humalog, Apidra

- Prior use of Afrezza in the last 3 months

- Unwilling to test blood glucose before or after each meal

- Exposure to systemic glucocorticoids within 6 weeks of screening

- Severe hypoglycemia in last 6 months or hypoglycemia unawareness

- Any medical condition which, in the opinion of the PI, would interfere with ability to
understand or respond to the administration of inhaled insulin