| Trial ID: | L1998 |
| Source ID: | NCT03324776
|
| Associated Drug: |
Afrezza Inhalant Product
|
| Title: |
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03324776/results
|
| Conditions: |
Type2 Diabetes
|
| Interventions: |
DRUG: Afrezza Inhalant Product
|
| Outcome Measures: |
Primary: Change in Percentage of HbA1c From Baseline to 3 Months, Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower, Baseline to 3 months | Secondary: Percentage of Patients With HbA1c Under 7% at 3 Months, Percentage of patients with uncontrolled type 2 diabetes with HbA1c that is under 7% at 3 months, 3 months|Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS, Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes., 3 months
|
| Sponsor/Collaborators: |
Sponsor: Model Clinical Research LLC | Collaborators: Mannkind Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-10-16
|
| Completion Date: |
2020-06-10
|
| Results First Posted: |
2024-06-26
|
| Last Update Posted: |
2024-06-26
|
| Locations: |
MODEL Clinical Research, Baltimore, Maryland, 21204, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03324776
|
