Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

• The change in estimated glomerular filtration rate (marker of kidney function) [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
• The change in estimated creatinine clearance (marker of kidney function) [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
• The change in fasting plasma glucose [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
• The change in body weight [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

• The change in estimated glomerular filtration rate (marker of kidney function) [ Time Frame: after 52 weeks ]
• The change in estimated creatinine clearance (marker of kidney function) [ Time Frame: after 52 weeks ]
• The change in fasting plasma glucose [ Time Frame: after 24 weeks ]
• The change in body weight [ Time Frame: after 24 weeks ]

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

• Drug: Dapagliflozin
  Tablets, Oral, 10 mg, Once Daily, 104 weeks
  Other Name: BMS-512148
• Drug: Dapagliflozin
  Tablets, Oral, 5 mg, Once Daily, 104 weeks
  Other Name: BMS-512148
• Drug: Placebo
  Tablets, Oral, 0 mg, Once Daily, 104 weeks

• Active Comparator: Dapagliflozin (10 mg)
  Intervention: Drug: Dapagliflozin
• Active Comparator: Dapagliflozin (5 mg)
  Intervention: Drug: Dapagliflozin
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
• Clinical diagnosis of moderate renal impairment

Exclusion Criteria:

• AST and /or ALT > 3.0 times the upper limit of normal
• Serum total bilirubin > 1.5 times ULN
• Symptoms of severely uncontrolled diabetes
• Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases