2. For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer, Metaglipr , or Avandametr) plus a serum creatinine greater than 1.5 mg/dL (133 μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study.