Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-89 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
2245 Patients enrolled
Trial Details
Trial ID
NCT01195662
Start Date
October 1 2010
End Date
February 1 2013
Last Update
December 29 2016
Active Locations (298)
Enter a location and click search to find clinical trials sorted by distance.
1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
3
Wilmax Clinical Research, Inc.
Mobile, Alabama, United States, 36608
4
43rd Medical Associates
Phoenix, Arizona, United States, 85051