A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
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 angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.
Key inclusion criteria
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:
Kansas City, Montana 64106, United States
North Massapequa, New York 11758, United States
Feasterville-Trevose, Pennsylvania 19053, United States
Sugarland, Texas 77479, United States
Sugarland, Texas 77479, United States
Kelowona, British Columbia V1Y 3G8, Canada
Bogota, Cundinamarca 0000, Colombia
Hyderabad, Andhra Pradesh 500 034, India
Del. Benito Juarez, Mexico City 03100, Mexico
Wroc#Aw, 50-088, Poland
WrocB Aw, 50-349, Poland
Yaroslav, 150062, Russia