Status:
COMPLETED
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
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 whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiote...
Eligibility Criteria
Inclusion
- Key inclusion criteria
- Participants willing and able to give signed and written informed consent
- Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (seated systolic blood pressure of 140 to 165 mm Hg and seated diastolic blood pressure 85 to 105 mm Hg)
- Mean 24-hour BP\>=130/80 mmHg determined by ABPM
- Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
- C-peptide level ≥0.8 ng/mL
- Body mass index ≤ 45.0 kg/m\^2
- Key exclusion criteria
- Aspartate aminotransferase or alanine aminotransferase level \>3\*upper limit of normal (ULN)
- Serum total bilirubin level \>1.5\*ULN
- Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
- Estimated creatinine clearance of \<60 mL/min
- Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
- Creatine kinase \>3\*ULN
- Positive for hepatitis B surface antigen
- Positive for antihepatitis C virus antibody
- Abnormal free T4 value
- History of diabetes insipidus
- Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- History of malignant and accelerated hypertension
- Known or suspected secondary hypertension
- Any of the following within 6 months of enrollment visit:
- Myocardial infarction
- Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
- Unstable angina
- Unstable congestive heart disease or New York Heart Association Class III or IV
- Transient ischemic attack or significant cerebrovascular disease
- Unstable or previously undiagnosed arrhythmia
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
2996 Patients enrolled
Trial Details
Trial ID
NCT01137474
Start Date
July 1 2010
End Date
February 1 2013
Last Update
January 26 2017
Active Locations (329)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
3
Iicr, Inc. (International Institute Of Clinical Research)
Ozark, Alabama, United States, 36360
4
Hope Research Institute
Phoenix, Arizona, United States, 85050