AST and /or ALT \> 2.5 times the upper limit of normal

Serum total bilirubin \> 2 mg/dL (34.2 µmol/L)

Creatinine kinase \> 3.0 times the upper limit of normal

Symptoms of severely uncontrolled diabetes

Serum creatinine ≥ 2.0 mg/dL

Calculated Cr-Clearance \< 50 ml/min (calculated by Cockroft-Gault formula)

Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Add-on to Thiazolidinedione (TZD) Failures