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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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 angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Dapagliflozin; Enzyme Inhibitors

Criteria

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