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| Name | Class |
|---|---|
| Mannkind Corporation | INDUSTRY |
| DexCom, Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetics | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afrezza Inhalant Product | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kipnes, M.D. | Diabetes and Glandular Disease Clinic, P.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes and Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | United States |
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| Screening to Week 16 |