Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117

Inclusion Criteria:

• Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
• Fasting plasma glucose: 126 - 240 mg/dL
• Hemoglobin A1c: 6 - 10%
• Estimated CrCl ≥ 60 mL/min
• ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN
• Stable and well controlled hypertension and/or dyslipidemia
• Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks

Exclusion Criteria:

• Women of childbearing potential
• Symptomatic diabetes with polyuria and/or polydipsia
• History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
• History of renal disease including diabetic nephropathy