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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT01195662

Run by

AstraZeneca

People needed

2245

Starts

2010-10-01

Expected to finish

2013-02-01

Last updated by the study team

2016-12-29

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• Wilmax Clinical Research, Inc. — Mobile, Alabama, United States
• 43rd Medical Associates — Phoenix, Arizona, United States
• Central Phoenix Medical Center — Tempe, Arizona, United States
• Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc — Tempe, Arizona, United States
• Clinical Research Advantage/Desert Clinical Research — Tempe, Arizona, United States
• Visions Clinical Research - Tucson — Tucson, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• Aureus Research, Inc. — Little Rock, Arkansas, United States
• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
• Cmp Research — Anaheim, California, United States
• Catalina Research Institute, Llc — Chino, California, United States
• Southland Clinical Research Center, Inc. — Fountain Valley, California, United States
• Marin Endocrine Care & Research, Inc. — Greenbrae, California, United States
• Del Rosario Medical Clinic, Inc. — Huntington Park, California, United States
• Time Clinical Research Inc. — Huntington Park, California, United States
• Clinica Medica San Miguel — Los Angeles, California, United States
• American Institute Of Research — Los Angeles, California, United States
• Randall G. Shue, D.O. — Los Angeles, California, United States
• Mcs Clinical Trials — Los Angeles, California, United States
• National Research Inst — Los Angeles, California, United States
• Diabetes Medical Center Of California — Northridge, California, United States
• Valley Clinical Trials — Northridge, California, United States
• Lucita M. Cruz,Md.,Inc. — Norwalk, California, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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