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)
Overview
- Phase
- Phase 3
- Intervention
- Dapagliflozin
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 2996
- Locations
- 161
- Primary Endpoint
- Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dapagliflozin, 10 mg
Oral tablets administered as 10 mg once daily for up to 12 weeks
Intervention: Dapagliflozin
Placebo-matching dapagliflozin
Oral tablets administered once daily in the morning
Intervention: Placebo-matching dapagliflozin
Dapagliflozin, 2. 5 mg
Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Intervention: Dapagliflozin
Dapagliflozin, 5 mg
Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Intervention: Dapagliflozin
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12
Time Frame: 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
Time Frame: 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 Outcomes
- Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12(From Baseline to Week 12)
- Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])(From Baseline to Week 12)
- Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)(From Baseline to Week 12)
- Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12(From Baseline to Week 12)