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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: Afrezza Inhalant Product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Afrezza Inhalant Product<br>Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm | Drug: Afrezza Inhalant Product<br>* Mealtime Ultra-Rapid Acting Insulin<br>* Other names: Afrezza Inhaled Insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline HbA1c | Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients having HbA1c under 7% | Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications. | 3 months | 
| Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS | Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhaled insulin