A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication

Inclusion Criteria:

- Written informed consent

- Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic
control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure
(SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105

- Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory
Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit

- Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for
Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in
combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1
additional antihypertensive medication for at least 4 weeks

- C-peptide ≥ 0.8 ng/mL

- Body Mass Index ≤ 45.0 kg/m2

- Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

- Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0*upper
limit of normal (ULN)

- Serum total bilirubin ≥ 1.5*ULN

- Creatinine kinase > 3*ULN

- Symptoms of severely uncontrolled diabetes

- History of malignant or accelerated hypertension

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