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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
With
Bristol-Myers Squibb
Age
18–89
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
