Trial · NCT01137474
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
NCT01137474, Phase 3, Completed, AstraZeneca; results first posted 2014-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01137474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01137474
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01137474
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,996 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes
- Interventions
- Dapagliflozin, Placebo-matching dapagliflozin
- First posted
- 2010-06-04
- Last updated
- 2017-01-26
- Other registries' IDs
- eudract:2010-019797-32
- Results first posted
- 2014-05-01
- Limitations and caveats
Study originally had 2 additional arms, dapagliflozin 2.5 and 5 mg, but enrolment stopped after Protocol Amendment 8 (1-11-11) implemented. Because endpoints focused on comparison of dapagliflozin 10 mg with placebo, only these arms were summarized.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 | From Baseline to Week 12 | This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included. | mm Hg | MEAN |
| PRIMARY | Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12 | From Baseline to Week 12 | This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included. | Percent | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward) | From Baseline to Week 12 | This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included. | mm Hg | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12 | From Baseline to Week 12 | This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included. | mm Hg | MEAN |
| SECONDARY | Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 12 | This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included. | mm Hg | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12 | From Baseline to Week 12 | This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 | Dapagliflozin 10 mg | -10.40 | Standard Error 0.8822 | mm Hg | |
| Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 | Placebo | -7.34 | Standard Error 0.8812 | mm Hg | |
| Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12 | Placebo | -0.10 | Standard Error 0.0631 | Percent | |
| Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12 | Dapagliflozin 10 mg | -0.56 | Standard Error 0.0633 | Percent | |
| Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward) | Placebo | -6.73 | Standard Error 1.2427 | mm Hg | |
| Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward) | Dapagliflozin 10 mg | -9.62 | Standard Error 1.2277 | mm Hg | |
| Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12 | Placebo | -4.79 | Standard Error 0.5418 | mm Hg | |
| Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12 | Dapagliflozin 10 mg | -5.79 | Standard Error 0.5425 | mm Hg | |
| Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]) | Placebo | -5.53 | Standard Error 0.8458 | mm Hg | |
| Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]) | Dapagliflozin 10 mg | -6.15 | Standard Error 0.8353 | mm Hg |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 311 | |
| Overall Study | STARTED | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 166 | |
| Overall Study | STARTED | Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) | 165 | |
| Overall Study | STARTED | Dapagliflozin 10 mg | 302 | |
| Overall Study | Received Treatment | Placebo | 311 | |
| Overall Study | Received Treatment | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 166 | |
| Overall Study | Received Treatment | Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) | 165 | |
| Overall Study | Received Treatment | Dapagliflozin 10 mg | 302 | |
| Overall Study | COMPLETED | Placebo | 287 | |
| Overall Study | COMPLETED | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 154 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Mastoiditis | Infections and infestations | Placebo | 0 | 311 | |
| serious | Mastoiditis | Infections and infestations | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 0 | 166 | |
| serious | Mastoiditis | Infections and infestations | Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) | 0 | 165 | |
| serious | Mastoiditis | Infections and infestations | Dapagliflozin 10 mg | 1 | 302 | |
| serious | Craniocerebral injury | Injury, poisoning and procedural complications | Placebo | 0 | 311 | |
| serious | Craniocerebral injury | Injury, poisoning and procedural complications | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 0 | 166 | |
| serious | Craniocerebral injury | Injury, poisoning and procedural complications | Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) | 1 | 165 | |
| serious | Craniocerebral injury | Injury, poisoning and procedural complications | Dapagliflozin 10 mg | 0 | 302 | |
| serious | Fall | Injury, poisoning and procedural complications | Placebo | 0 | 311 | |
| serious | Fall | Injury, poisoning and procedural complications | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 0 | 166 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | ||
| Total, all-cause mortality | Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) | ||
| Total, all-cause mortality | Dapagliflozin 10 mg | ||
| Total, other adverse events | Placebo | 0 | 311 |
| Total, other adverse events | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 0 | 166 |
| Total, other adverse events | Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) | 0 | 165 |
| Total, other adverse events | Dapagliflozin 10 mg | 0 | 302 |
| Total, serious adverse events | Placebo | 4 | 311 |
| Total, serious adverse events | Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) | 3 | 166 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38770818 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01137474
GET https://conductscience.org/api/trials/v1/NCT01137474/events?page=2