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| ID | Type | Description | Link |
|---|---|---|---|
| U54RR014616 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sitagliptin 100 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100 mg by mouth once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) Change From Baseline | Baseline, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months | 4 months | |
| Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year | 1 year | |
| Number of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Hsia, MD | Charles Drew University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Drew University of Medicine and Science | Los Angeles | California | 90059 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21550951 | Derived | Hsia SH, Navar MD, Duran P, Shaheen M, Davidson MB. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract. 2011 Sep-Oct;17(5):691-8. doi: 10.4158/EP10405.OR. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin Treatment | Sitagliptin 100 mg orally once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin Treatment | Sitagliptin 100 mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Hemoglobin A1c (HbA1c) Change From Baseline | Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months) | Posted | Mean | Standard Deviation | percentage | Baseline, 4 months |
|
|
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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 | Sitagliptin Treatment | Sitagliptin 100 mg once daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stanley H. Hsia, MD | Charles R. Drew University of Medicine and Science | 323-357-3633 | stanleyhsia@cdrewu.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 1 year |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months | Posted | Number | participants | 4 months |
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|
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| Secondary | Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year | Posted | Number | participants | 1 year |
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| Secondary | Number of Adverse Events | Posted | Number | Adverse event | 1 year |
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|
|
| 0 |
| 108 |
| 0 |
| 108 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |