Trial · NCT01042977
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
NCT01042977, Phase 3, Completed, AstraZeneca; results first posted 2013-08-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease. Trials, record NCT01042977. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01042977
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
- NCT number
- NCT01042977
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 964 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Inadequate Glycaemic Control
- Interventions
- Dapagliflozin, Placebo
- First posted
- 2010-01-06
- Last updated
- 2014-02-17
- Results first posted
- 2013-08-23
- Limitations and caveats
For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. For HbA1c: excluding data after glycemic rescue, Weight: including data after rescue, SBP: excluding data after anti-hypertensive rescue.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change in HbA1c Levels | Baseline to Week 24 | To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24. |
| Primary | Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit | Baseline to Week 24 | To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure. |
| Secondary | Adjusted Mean Percent Change in Body Weight | Baseline to Week 24 | To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo. |
| Secondary | Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m² | Baseline to Week 24 | To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum. |
| Secondary | Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) | Baseline to Week 8 | To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo. |
| Secondary | Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF) | Baseline to Week 24 | To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo. |
| Secondary | Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg | Baseline to Week 8 | To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change in HbA1c Levels | Baseline to Week 24 | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Percent | LEAST_SQUARES_MEAN |
| PRIMARY | Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit | Baseline to Week 24 | Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values | Percentage of participants | NUMBER |
| SECONDARY | Adjusted Mean Percent Change in Body Weight | Baseline to Week 24 | Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values | Percentage of Body Weight | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m² | Baseline to Week 24 | Full Analysis Set, subjects with baseline BMI ≥27 kg/m2 and Week 24 (LOCF) values | Percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) | Baseline to Week 8 | Full Analysis Set, subjects with non-missing baseline and Week 8 (LOCF) values | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF) | Baseline to Week 24 | Full Analysis set, subjects with non-missing baseline and Week 24 (LOCF) values | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg | Baseline to Week 8 | Full Analysis set, participants with baseline seated SBP ≥130 mmHg and Week 8 (LOCF) value | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change in HbA1c Levels | Dapagliflozin | -0.33 | 95% Confidence Interval 0.0434 | Percent | |
| Adjusted Mean Change in HbA1c Levels | Placebo | 0.07 | 95% Confidence Interval -0.02 to 0.15 | Percent | |
| Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit | Dapagliflozin | 10.0 | 95% Confidence Interval 0.7 | Percentage of participants | |
| Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit | Placebo | 1.9 | 95% Confidence Interval 7.3 | Percentage of participants | |
| Adjusted Mean Percent Change in Body Weight | Dapagliflozin | -2.53 | 95% Confidence Interval 0.1770 | Percentage of Body Weight | |
| Adjusted Mean Percent Change in Body Weight | Placebo | -0.61 | 95% Confidence Interval 0.1736 | Percentage of Body Weight | |
| Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m² | Dapagliflozin | 18.4 | 95% Confidence Interval 1.051 | Percentage of participants | |
| Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m² | Placebo | 4.8 | 95% Confidence Interval 1.876 | Percentage of participants | |
| Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) | Dapagliflozin | -1.85 | 95% Confidence Interval 0.7105 | mmHg | |
| Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) | Placebo | 0.86 | 95% Confidence Interval 0.7135 | mmHg |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapagliflozin | 482 | |
| Overall Study | STARTED | Placebo | 483 | |
| Overall Study | COMPLETED | Dapagliflozin | 441 | |
| Overall Study | COMPLETED | Placebo | 428 | |
| Overall Study | NOT COMPLETED | Dapagliflozin | 41 | |
| Overall Study | NOT COMPLETED | Placebo | 55 |
Source ClinicalTrials.gov
Adverse events162
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 |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Dapagliflozin | 27 | 482 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 18 | 483 | |
| other | Nasopharyngitis | Infections and infestations | Dapagliflozin | 26 | 482 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 26 | 483 | |
| other | Upper respiratory tract infection | Infections and infestations | Dapagliflozin | 15 | 482 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 24 | 483 | |
| other | Hypoglycemia | Endocrine disorders | Dapagliflozin | 101 | 482 | |
| other | Hypoglycemia | Endocrine disorders | Placebo | 84 | 483 | |
| serious | Angina unstable | Cardiac disorders | Dapagliflozin | 3 | 482 | |
| serious | Angina unstable | Cardiac disorders | Placebo | 2 | 483 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapagliflozin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dapagliflozin | 147 | 482 |
| Total, other adverse events | Placebo | 134 | 483 |
| Total, serious adverse events | Dapagliflozin | 41 | 482 |
| Total, serious adverse events | Placebo | 46 | 483 |
Source ClinicalTrials.gov
Papers1
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dapagliflozin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01042977
GET https://conductscience.org/api/trials/v1/NCT01042977/events?page=2