Clareo Health | 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
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
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
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 be 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
