A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin.

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Inclusion Criteria:

• Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
• Subjects receiving insulin and metformin and/or a thiazolidinedione
• Body Mass Index <=45.0 kg/m2
• Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
• No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)

Exclusion Criteria:

• History of type 1 diabetes
• AST and/or ALT >2.5 times the upper limit of normal
• Creatinine kinase ≥3 times the upper limit of normal
• Symptoms of severely uncontrolled diabetes
• History of hypoglycemic unawareness
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases