A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections

Study Overview
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Brief Summary
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The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data

Official Title
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A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections

Conditions
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Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Drug: Afrezza Inhalant Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections Screening A1c 7.5 % - 11.5% inclusive Willing and able to wear CGM system during the study Willing to use only inhaled insulin (Afrezza®) at meals and for correction Able to understand, speak, read and write English Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy Exclusion Criteria: Diagnosed with COPD Is an active smoker , or has smoked in the past 6 months Diagnosed with asthma Pregnancy, breast-feeding or planning to become pregnant during study period Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study Use of oral or injected corticosteroid within 6 weeks of study enrollment Enrollment in another investigational trial at the time of screening

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: Type 2 Diabetics<br>Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks. Participants will attend study visits at Day 0, Weeks 1, 2, 3, 4, 8, 12 and 16, where insulin titration may be performed based on CGM readings. Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments. Participants will wear CMG throughout the study. At final study visit, CGM system will be collected. A1c, FEV1 and Quality of Life Questionnaires will be collected. Pregnancy test will be collected for all females of child-bearing potential. Participants will be transitioned back to Multiple Daily Injections plus basal or may choose to continue on commercial Afrezza® inhaled insulin plus basal | Drug: Afrezza Inhalant Product<br>* Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time In Range | Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®). | Week 2 to End of Study | 
| Hypoglycemia | Incidence of significant hypoglycemic events | Week 2 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Evaluation of A1c from visit week 2 baseline to final study visit | Week 2 to Week 16 | 
| Quality of Life Questionnaires | Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit. | Screening to Week 16 |