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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014308-79 | EudraCT Number |
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The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-770767 ± metformin (Treatment A) | Experimental |
| |
| BMS-770767 ± metformin (Treatment B) | Experimental |
| |
| BMS-770767 ± metformin (Treatment C) | Experimental |
| |
| BMS-770767 ± metformin (Treatment D) | Experimental |
| |
| Placebo ± metformin (Treatment E) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-770767 | Drug | Capsule, Oral, 15mg, Active, Daily, 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose Improvement | Within seven days following dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily glucose (3-day 7 pt-fingerstick) | Within 28 days following dosing | |
| Four (4)-hour post-prandial glucose AUC | Within 28 days following dosing | |
| HbA1C |
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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 |
|---|---|---|---|---|---|---|
| Marina Raikhel, Md | Lomita | California | 90717 | United States | ||
| Nevada Alliance Against Diabetes |
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| BMS-770767 |
| Drug |
Capsule, Oral, 50mg, Active, Daily, 28 days |
|
| BMS-770767 | Drug | Capsule, Oral, 150mg, Active, Daily, 28 days |
|
| BMS-770767 | Drug | Capsule, Oral, 50mg BID, Active, Daily, 28 days |
|
| Placebo | Drug | Capsule, Oral, 0mg, Daily, 28 days |
|
| Metformin | Drug | Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days |
|
| Within 28 days following dosing |
| Lipid profiles | Within 28 days following dosing |
| Las Vegas |
| Nevada |
| 89101 |
| United States |
| Local Institution | Caboolture | Queensland | 4510 | Australia |
| Local Institution | Meadowbrook | Queensland | 4131 | Australia |
| Local Institution | Daw Park | South Australia | 5041 | Australia |
| Local Institution | Geelong | Victoria | 3220 | Australia |
| Local Institution | Nedlands | Western Australia | 6009 | Australia |
| Local Institution | Winnipeg | Manitoba | R3P 1R9 | Canada |
| Local Institution | Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| Local Institution | Brampton | Ontario | L6T 3J1 | Canada |
| Local Institution | Toronto | Ontario | M4G 3E8 | Canada |
| Local Institution | Charlottetown | Prince Edward Island | C1A 5Y9 | Canada |
| Local Institution | Drummondville | Quebec | J2B 7T1 | Canada |
| Local Institution | Lachine | Quebec | H8S 2E4 | Canada |
| Local Institution | Laval | Quebec | H7T 2P5 | Canada |
| Local Institution | Montreal | Quebec | H3J 2V5 | Canada |
| Local Institution | Incheon | 405-760 | South Korea |
| Local Institution | Suwon | 443-721 | South Korea |
| 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 |
|---|---|
| C000625006 | BMS-770767 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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