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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Experimental |
| |
| Arm 5 | Experimental |
| |
| Arm 6 | Placebo Comparator |
| |
| Arm 7 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin | Drug | Tablets, Oral, 2.5 mg, Once daily, 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in HbA1c compared to placebo. | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion | at Weeks 6 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Bayou La Batre | Alabama | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27461213 | Derived | Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3. | |
| 26894924 | Derived |
| Label | URL |
|---|---|
| MB102-008 \_CSR\_synopsis | View source |
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| dapagliflozin |
| Drug |
Tablets, Oral, 5 mg, Once daily, 12 weeks. |
|
| dapagliflozin | Drug | Tablets, Oral, 10 mg, Once daily, 12 weeks. |
|
| dapagliflozin | Drug | Tablets, Oral, 20 mg, Once daily, 12 weeks. |
|
| dapagliflozin | Drug | Tablets, Oral, 50 mg, Once daily, 12 weeks. |
|
| placebo | Drug | Tablets, Oral, 0 mg, Once daily, 12 weeks. |
|
| metformin | Drug | Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks. |
|
| Birmingham |
| Alabama |
| United States |
| Local Institution | Huntsville | Alabama | United States |
| Local Institution | Mobile | Alabama | United States |
| Local Institution | Chandler | Arizona | United States |
| Local Institution | Tucson | Arizona | United States |
| Local Institution | Fayetteville | Arkansas | United States |
| Local Institution | Hot Springs | Arkansas | United States |
| Local Institution | Beverly Hills | California | United States |
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| Local Institution | Orange | California | United States |
| Local Institution | Redondo Beach | California | United States |
| Local Institution | San Diego | California | United States |
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| Local Institution | Colorado Springs | Colorado | United States |
| Local Institution | Denver | Colorado | United States |
| Local Institution | Boynton Beach | Florida | United States |
| Local Institution | Brandon | Florida | United States |
| Local Institution | Delray Beach | Florida | United States |
| Local Institution | Holly Hill | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Instiuttion | Jacksonville | Florida | United States |
| Local Institution | New Port Richey | Florida | United States |
| Local Institution | Orlando | Florida | United States |
| Local Institution | Ormond Beach | Florida | United States |
| Local Institution | Augusta | Georgia | United States |
| Local Institution | Blue Ridge | Georgia | United States |
| Local Institution | Honolulu | Hawaii | United States |
| Local Institution | Indianapolis | Indiana | United States |
| Local Institution | Lafayette | Indiana | United States |
| Local Institution | Arkansas City | Kansas | United States |
| Local Institution | Baton Rouge | Louisiana | United States |
| Local Institution | Columbia | Maryland | United States |
| Local Institution | Elkton | Maryland | United States |
| Local Institution | Sudbury | Massachusetts | United States |
| Local Institution | Worcester | Massachusetts | United States |
| Local Institution | Dearborn | Michigan | United States |
| Local Institution | Royal Oak | Michigan | United States |
| Local Institution | Brooklyn Center | Minnesota | United States |
| Local Insitution | Edina | Minnesota | United States |
| Local Institution | Minneapolis | Minnesota | United States |
| Local Institution | Hattiesburg | Mississippi | United States |
| Local Institution | Jackson | Mississippi | United States |
| Local Institution | Chesterfield | Missouri | United States |
| Local Institution | Kansas City | Missouri | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | Scottsbluff | Nebraska | United States |
| Local Institution | North Las Vegas | Nevada | United States |
| Local Institution | Albuquerque | New Mexico | United States |
| Local Institution | Los Alamos | New Mexico | United States |
| Local Institution | Albany | New York | United States |
| Local Institution | Bronxville | New York | United States |
| Local Institution | Camillus | New York | United States |
| Local Institution | Cooperstown | New York | United States |
| Local Instiution | New Hyde Park | New York | United States |
| Local Institution | West Seneca | New York | United States |
| Local Institution | Charlotte | North Carolina | United States |
| Local Institution | High Point | North Carolina | United States |
| Local Institution | Morehead City | North Carolina | United States |
| Local Institution | Raleigh | North Carolina | United States |
| Local Institution | Wilmington | North Carolina | United States |
| Local Institution | Akron | Ohio | United States |
| Local Institution | Beachwood | Ohio | United States |
| Local Institution | Cincinnati | Ohio | United States |
| Local Institution | Cleveland | Ohio | United States |
| Local Institution | Dayton | Ohio | United States |
| Local Institution | Mogadore | Ohio | United States |
| Local Institution | Newark | Ohio | United States |
| Local Institution | Zanesville | Ohio | United States |
| Local Institution | Bethany | Oklahoma | United States |
| Local Institution | Yukon | Oklahoma | United States |
| Local Institution | Bend | Oregon | United States |
| Local Institution | Eugene | Oregon | United States |
| Local Institution | Hillsboro | Oregon | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Bensalem | Pennsylvania | United States |
| Local Institution | Feasterville | Pennsylvania | United States |
| Local Institution | Levittown | Pennsylvania | United States |
| Local Institution | Morrisville | Pennsylvania | United States |
| Local Institution | Reading | Pennsylvania | United States |
| Local Institution | Cumberland | Rhode Island | United States |
| Local Institution | Johnston | Rhode Island | United States |
| Local Institution | Anderson | South Carolina | United States |
| Local Institution | Simpsonville | South Carolina | United States |
| Local Institution | Summerville | South Carolina | United States |
| Local Institution | Taylors | South Carolina | United States |
| Local Institution | Rapid City | South Dakota | United States |
| Local Institution | Memphis | Tennessee | United States |
| Local Institution | Nashville | Tennessee | United States |
| Local Institution | Selmer | Tennessee | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Bellaire | Texas | United States |
| Local Institution | Bryan | Texas | United States |
| Local Institution | El Paso | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Irving | Texas | United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | Salt Lake City | Utah | United States |
| Local Institution | Burke | Virginia | United States |
| Local Institution | Hampton | Virginia | United States |
| Local Institution | Norfolk | Virginia | United States |
| Local Institution | Richmond | Virginia | United States |
| Local Institution | Virginia Beach | Virginia | United States |
| Local Institution | Edmonds | Washington | United States |
| Local Institution | Renton | Washington | United States |
| Local Institution | Spokane | Washington | United States |
| Local Institution | Vancouver | Washington | United States |
| Local Institution | Milwaukee | Wisconsin | United States |
| Local Institution | West Allis | Wisconsin | United States |
| Local Institution | Calgary | Alberta | Canada |
| Local Institution | Edmonton | Alberta | Canada |
| Local Institution | Langley | British Columbia | Canada |
| Local Institution | Surrey | British Columbia | Canada |
| Local Institution | Vancouver | British Columbia | Canada |
| Local Institution | Winnipeg | Manitoba | Canada |
| Local institution | Bathurst | New Brunswick | Canada |
| Local Institution | Moncton | New Brunswick | Canada |
| Local Institution | Saint John's | New Brunswick | Canada |
| Local Institution | St. John's | Newfoundland and Labrador | Canada |
| Local Institution | Corunna | Ontario | Canada |
| Local Institution | Etobicoke | Ontario | Canada |
| Local Institution | Kitchener | Ontario | Canada |
| Local Institution | Newmarket | Ontario | Canada |
| Local Institution | Sarnia | Ontario | Canada |
| Local Institution | Toronto | Ontario | Canada |
| Local Institution | Charlottetown | Prince Edward Island | Canada |
| Local Institution | Drummondville | Quebec | Canada |
| Local Institution | Granby | Quebec | Canada |
| Local Institution | Greenfield Park | Quebec | Canada |
| Local Institution | Rimouski | Quebec | Canada |
| Local Institution | Saint-Léonard | Quebec | Canada |
| Local Institution | Ste-Foy | Quebec | Canada |
| Local Institution | Saskatoon | Saskatchewan | Canada |
| Local Institution | Aguascalientes | Aguascalientes | Mexico |
| Local Institution | Durango | Durango | Mexico |
| Local Institution | Guadalajara | Jalisco | Mexico |
| Local Institution | Zapopan | Jalisco | Mexico |
| Local Institution | Cuernavaca | Morelos | Mexico |
| Local Institution | Monterrey | Nuevo León | Mexico |
| Local Institution | Caguas | Puerto Rico |
| Local Institution | Manati | Puerto Rico |
| Local Institution | San Juan | Puerto Rico |
| Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19. |
| 19114612 | Derived | List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009 Apr;32(4):650-7. doi: 10.2337/dc08-1863. Epub 2008 Dec 29. |
| 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 |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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