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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Saxagliptin |
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| 2 | Active Comparator | Metformin Extended Release |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | 5mg oral tablet once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Level From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Baseline to week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boaz Hirschberg, MD | AstraZeneca | Study Director |
| Vivian Fonseca, MD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Jonesboro | Arkansas | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22192246 | Derived | Fonseca V, Zhu T, Karyekar C, Hirshberg B. Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage. Diabetes Obes Metab. 2012 Apr;14(4):365-71. doi: 10.1111/j.1463-1326.2011.01553.x. Epub 2012 Jan 18. |
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Of the 393 subjects who entered the lead-in period, 111 subjects did not enter the randomized, double-blind treatment period. Thus, a total of 282 subjects were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin + Metformin | Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL) |
| FG001 | Metformin (DB) + Metformin (OL) | Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Metformin XR | Drug | 500mg oral tablet once daily |
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| Metformin XR | Drug | 750mg, 2 tablets once daily |
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| Baseline to week 18 |
| Change in FPG From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Baseline to week 18 |
| Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1) | Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set) | Week 18 (LOCF) |
| Anaheim |
| California |
| United States |
| Research Site | Fountain Valley | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Pasadena | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Wellington | Florida | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Springfield | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Salisbury | North Carolina | United States |
| Research Site | Wilmington | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Marion | Ohio | United States |
| Research Site | Simpsonville | South Carolina | United States |
| Research Site | Bristol | Tennessee | United States |
| Research Site | Alexandria | Virginia | United States |
| Research Site | Burke | Virginia | United States |
| Research Site | Manassas | Virginia | United States |
| Research Site | Barranquilla | Atlántico | Colombia |
| Research Site | Barranquilla | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | Curridabat | Provincia de San José | Costa Rica |
| Research Site | Los Yoses | Provincia de San José | Costa Rica |
| Research Site | Heredia | Costa Rica |
| Research Site | México | D.f. | Mexico |
| Research Site | Durango | Durango | Mexico |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Zapopan | Jalisco | Mexico |
| Research Site | Cuernavaca | Morelos | Mexico |
| Research Site | Querétaro City | Querétaro | Mexico |
| Research Site | Lima | Peru |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin + Metformin | Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL) |
| BG001 | Metformin (DB) + Metformin (OL) | Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 HbA1c Level From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Posted | Mean | Standard Error | Percent | Baseline to week 18 |
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| Secondary | Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Posted | Mean | Standard Error | mg/dL | Baseline to week 18 |
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| Secondary | Change in FPG From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Posted | Mean | Standard Error | mg/dL | Baseline to week 18 |
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| Secondary | Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1) | Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set) | Posted | Number | Percentage of Participants | Week 18 (LOCF) |
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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 | Saxagliptin + Metformin | Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL) | 0 | 138 | 21 | 138 | ||
| EG001 | Metformin (DB) + Metformin (OL) | Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL) | 3 | 144 | 16 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
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| Male |
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| Adjusted Change from Baseline to Week 18 |
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