| Trial ID: | L2141 |
| Source ID: | NCT04125082
|
| Associated Drug: |
Afrezza Inhalant Product
|
| Title: |
A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Treated With Insulin
|
| Interventions: |
DRUG: Afrezza Inhalant Product
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Diabetes and Glandular Disease Clinic | Collaborators: Mannkind Corporation|DexCom, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
29
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-02-27
|
| Completion Date: |
2020-03-15
|
| Results First Posted: |
|
| Last Update Posted: |
2020-01-30
|
| Locations: |
Diabetes and Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04125082
|
