Phase 3
Completed N=944
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
Source: ClinicalTrials.gov NCT01137474 ↗Enrolled (actual)
944
Serious AEs
1.2%
Results posted
May 2014
Primary outcomePrimary: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 — -10.40; -7.34 mm Hg — p=0.0010
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 |
-10.40; -7.34 | 0.0010 sig |
| PRIMARY Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12 |
-0.10; -0.56 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward) |
-6.73; -9.62 | 0.0043 sig |
| SECONDARY Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12 |
-4.79; -5.79 | 0.0843 |
| SECONDARY Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]) |
-5.53; -6.15 | — |
| SECONDARY Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12 |
0.05; -0.27 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01137474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.