Phase 3
Completed N=582
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
Source: ClinicalTrials.gov NCT01195662 ↗Enrolled (actual)
582
Serious AEs
1.6%
Results posted
May 2014
Primary outcomePrimary: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants — -5.13; -7.93; -6.05; -9.69 mmHg — p=0.0002
Summary
The purpose of this study is to learn if BMS-512148 (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 (ACEI) or an Angiotensin Receptor Blocker (ARB).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 for 12 Week Double-Blind Treatment Period - Randomized Participants |
-5.13; -7.93; -6.05; -9.69; -6.80; -11.38 | 0.0002 sig |
| PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants |
-0.06; -0.41; -0.07; -0.58; -0.02; -0.63 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF) |
-6.88; -11.33 | 0.0012 sig |
| SECONDARY Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants |
-3.84; -5.22; -4.28; -5.57; -4.76; -6.53 | 0.1619 |
| SECONDARY Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF) |
-5.57; -7.56 | — |
| SECONDARY Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants |
-0.03; -0.43 | — |
| SECONDARY Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue |
0; 0; 0; 2; 6; 1 | — |
| SECONDARY Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue |
1; 0; 1; 3; 0; 1 | — |
| SECONDARY Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue |
0; 3; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue |
137; 130; 9; 10; 0; 0 | — |
| SECONDARY Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue |
0.9; 0.9; 2.0; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT01195662). 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.