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
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01137474
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2996
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dapagliflozin, 10 mg Dapagliflozin Oral tablets administered as 10 mg once daily for up to 12 weeks Placebo-matching dapagliflozin Placebo-matching dapagliflozin Oral tablets administered once daily in the morning Dapagliflozin, 5 mg Dapagliflozin Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) Dapagliflozin, 2. 5 mg Dapagliflozin Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 From Baseline to Week 12 Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12 From Baseline to Week 12 HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
- Secondary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12 From Baseline to Week 12 All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.
Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]) From Baseline to Week 12 Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.
Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward) From Baseline to Week 12 Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.
Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12 From Baseline to Week 12 Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.
Trial Locations
- Locations (161)
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Horizon Research Group, Inc.
🇺🇸Mobile, Alabama, United States
Iicr, Inc. (International Institute Of Clinical Research)
🇺🇸Ozark, Alabama, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
43rd Medical Associates
🇺🇸Phoenix, Arizona, United States
Central Phoenix Medical Clinic, Llc
🇺🇸Tempe, Arizona, United States
Clinical Research Advantage/Desert Clinical Research
🇺🇸Tempe, Arizona, United States
Visions Clinical Research - Tucson
🇺🇸Tucson, Arizona, United States
Eclipse Clinical Research
🇺🇸Tucson, Arizona, United States
Aureus Research, Inc.
🇺🇸Little Rock, Arkansas, United States
Scroll for more (151 remaining)University Of Alabama At Birmingham🇺🇸Birmingham, Alabama, United States