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| Name | Class |
|---|---|
| Mannkind Corporation | INDUSTRY |
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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.
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 hemoglobin A1c (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 HbA1c's. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Addition of mealtime Afrezza Inhalation Powder | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afrezza Inhalant Product | Drug | Mealtime Ultra-Rapid Acting Insulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Levin, MD | Senior Director of MODEL Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MODEL Clinical Research | Baltimore | Maryland | 21204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Addition of Mealtime Afrezza Inhalation Powder | 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 Afrezza Inhalant Product: Mealtime Ultra-Rapid Acting Insulin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Addition of Mealtime Afrezza Inhalation Powder | Adults with Type 2 diabetes on a variety of glucose-lowering regimens instructed to add mealtime Afrezza for 3 months and to follow a weekly treat-to-target BG testing regimen, making Afrezza dose changes according to an Afrezza Titration Algorithm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | change in percentage of HbA1c | Baseline to 3 months |
|
|
3.5 months
Adverse Events were collected/reviewed at every visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Addition of Mealtime Afrezza Inhalation Powder | Adults with Type 2 diabetes on a variety of glucose-lowering regimens instructed to add mealtime Afrezza for 3 months and to follow a weekly treat-to-target BG testing regimen, making Afrezza dose changes according to an Afrezza Titration Algorithm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip Levin, MD | MODEL Clinical Research LLC | 4102413438 | pal3420@yahoo.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2018 | Jun 14, 2022 | Prot_000.pdf |
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Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes.
| 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage of HbA1c |
|
| Percent of Time Blood glucose (BG) under 70 mg/dL on Continuous Glucose Monitoring System (CGMS) | Mean | Standard Deviation | percentage of time with glucose <70mg/dL |
|
| Participants |
|
|
| 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 | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent of time with glucose <70mg/dL | 3 months |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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