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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - 89
Updated:4/21/2016
Start Date:October 2010
End Date:February 2013

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can
improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled
hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin
Receptor Blocker (ARB).The safety of this treatment will also be studied


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
We found this trial at
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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3801 N. Fairfax Drive
Arlington, Virginia 22203
703-527-8100
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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3924 9th Avenue West
Bradenton, Florida 34205
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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303 Williams Ave
Huntsville, Alabama 35801
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1800 SW 1 ST #208
Miami, Florida 33135
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5430 Fredericksburg Road
San Antonio, Texas 78229
210-377-2873
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500 Chase Parkway
Waterbury, Connecticut 06708
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