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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this clinical research study is to assess the safety of, exposure to, and biological effects of BMS-512148 in stable Type 2 diabetic subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
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| 2 | Active Comparator |
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| 3 | Active Comparator |
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| 4 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-512148 | Drug | Capsules, Oral, 100 mg, Once daily, 14 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects | Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin | Exposure to BMS-512148 and BMS-511926 | 14 days |
| To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis |
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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 | Fort Lauderdale | Florida | 33301 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19129749 | Result | Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7. |
| Label | URL |
|---|---|
| MB102-003 \_CSR\_synopsis | View source |
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| BMS-512148 | Drug | Capsules, Oral, 25 mg, Once daily, 14 days. |
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| BMS-512148 | Drug | Capsules, Oral, 5 mg, Once daily, 14 days. |
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| Placebo | Drug | Capsules, Oral, 0 mg, Once daily, 14 days. |
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Fasting and post-prandial serum glucose, serum fructosamine, serum insulin, and serum C-peptide and urinary glucose and urinary calcium |
| 14 days |
| To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine | calcium, magnesium, sodium, potassium, phosphate, chloride, uric acid, oxalate, citrate, total protein, albumin, osmolality, deoxypyridinoline (D-pyr) cross-links, C-telopetide (CTX), N-acetyl-β- D-glucoasaminidase (NAG), and β2-microglubulin (β2-MG) | 14 days |
| To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on the following safety markers in serum | Serum osteocalcin, parathyroid hormone (PTH), 25-Vitamin D, and 1,25-Vitamin D | 14 days |
| To assess the effect of BMS-512148 administered alone or concomitantly with metformin on the percent inhibition of renal glucose reabsorption | Percent inhibition of renal glucose resorption over each 0-4 h, 4-8 h, and 8-12 h post-dose interval calculated from the amount of renally filtered glucose and the amount of glucose excreted in the urine for each collection interval. | 14 days |
| To assess the effects of BMS-512148 on the PK of metformin in diabetic subjects. | Exposure to metformin | 14 days |
| To identify potential biomarkers in both urine and blood | Serum and urine for metabonomic assessment | 14 days |
| Miami |
| Florida |
| 33169 |
| United States |
| Local Institution | Orlando | Florida | 32809 | United States |
| Local Institution | New Orleans | Louisiana | 70119 | United States |
| Local Institution | San Antonio | Texas | 78229-3894 | United States |
| 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 |
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