Trial · NCT01031680

Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension

NCT01031680, 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, Cardiovascular Disease and Hypertension. Trials, record NCT01031680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01031680

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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, Cardiovascular Disease and Hypertension
NCT number: NCT01031680
Status: Completed
Phases: Phase 3
Enrollment: 922 participants, actual
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension, Inadequate Glycaemic Control
Interventions: Dapagliflozin, Placebo
First posted: 2009-12-14
Last updated: 2013-10-29
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 outcomes6

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 and hypertension, 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 and hypertension 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 Change in Seated Systolic Blood Pressure (SBP)	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 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	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) 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	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.

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 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, participants with non-missing baseline and Week 24 (LOCF) values	Percentage of participants	NUMBER
SECONDARY	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)	Baseline to Week 8	Full Analysis Set, participants with non-missing baseline and Week 8 (LOCF) values	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Percent Change in Body Weight	Baseline to Week 24	Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values	Percentage of Body Weight	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)	Baseline to Week 24	Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values	mmHg	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; participants with baseline BMI ≥27 kg/m² and Week 24 (LOCF) body weight value	Percentage of participants	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Adjusted Mean Change in HbA1c Levels	Experimental	-0.38	95% Confidence Interval -0.46 to -0.30	Percent
Adjusted Mean Change in HbA1c Levels	Placebo Comparator	0.08	95% Confidence Interval 0.01 to 0.16	Percent
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit	Experimental	11.7	95% Confidence Interval 8.7 to 14.7	Percentage of participants
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit	Placebo Comparator	0.9	95% Confidence Interval 0.0 to 1.8	Percentage of participants
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)	Experimental	-2.96	95% Confidence Interval -4.29 to -1.64	mmHg
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)	Placebo Comparator	-0.99	95% Confidence Interval -2.29 to 0.32	mmHg
Adjusted Mean Percent Change in Body Weight	Experimental	-2.56	95% Confidence Interval -2.88 to -2.24	Percentage of Body Weight
Adjusted Mean Percent Change in Body Weight	Placebo Comparator	-0.30	95% Confidence Interval -0.62 to 0.03	Percentage of Body Weight
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)	Experimental	-2.99	95% Confidence Interval -4.36 to -1.61	mmHg
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)	Placebo Comparator	-1.03	95% Confidence Interval -2.39 to 0.32	mmHg

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental	460
Overall Study	STARTED	Placebo Comparator	462
Overall Study	COMPLETED	Experimental	403
Overall Study	COMPLETED	Placebo Comparator	404
Overall Study	NOT COMPLETED	Experimental	57
Overall Study	NOT COMPLETED	Placebo Comparator	58

Source ClinicalTrials.gov

Adverse events104

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
other	Hypoglycemia	Endocrine disorders	Experimental	89	460
other	Hypoglycemia	Endocrine disorders	Placebo Comparator	84	462
serious	Gastroenteritis	Infections and infestations	Experimental	2	460
serious	Gastroenteritis	Infections and infestations	Placebo Comparator	1	462
serious	Anal Abscess	Infections and infestations	Experimental	1	460
serious	Anal Abscess	Infections and infestations	Placebo Comparator	0	462
serious	Diarrhoea Infectious	Infections and infestations	Experimental	1	460
serious	Diarrhoea Infectious	Infections and infestations	Placebo Comparator	0	462
serious	Diverticulitis	Infections and infestations	Experimental	1	460
serious	Diverticulitis	Infections and infestations	Placebo Comparator	0	462

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental
Total, all-cause mortality	Placebo Comparator
Total, other adverse events	Experimental	89	460
Total, other adverse events	Placebo Comparator	84	462
Total, serious adverse events	Experimental	27	460
Total, serious adverse events	Placebo Comparator	26	462

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25852208	DERIVED	PubMed
38770818	DERIVED	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
Experimental vs Placebo Comparator: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01031680

GET https://conductscience.org/api/trials/v1/NCT01031680/events?page=2

API reference For AI assistants