| Outcome Measures: |
Primary: 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 | Secondary: 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, 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
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| Locations: |
Local Institution, Fort Lauderdale, Florida, 33301, United States|Local Institution, 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
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