Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
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ClinicalTrials.gov Identifier: NCT01042977 |
Recruitment Status
:
Completed
First Posted
: January 6, 2010
Results First Posted
: August 23, 2013
Last Update Posted
: February 17, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Cardiovascular Disease Inadequate Glycaemic Control | Drug: Dapagliflozin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 964 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A 24-week, Multicentre, Randomised, Double-blind,Age-stratified, Placebo Controlled Phase III Study With an 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
dapagliflozin 10 mg tablet
|
Drug: Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
|
Placebo Comparator: 2
matching placebo tablet
|
Drug: Placebo
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
|
- Adjusted Mean Change in HbA1c Levels [ Time Frame: 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.
- Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit [ Time Frame: 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.
- Adjusted Mean Percent Change in Body Weight [ Time Frame: Baseline to Week 24 ]To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.
- Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m² [ Time Frame: 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.
- Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) [ Time Frame: 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.
- Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF) [ Time Frame: 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.
- Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg [ Time Frame: 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.

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 diabetes mellitus.
- Cardiovascular disease
- Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
Exclusion Criteria:
- Patients with type 1 diabetes or diabetes insipidus
- Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
- Any clinically significant illness, which would compromise the patient's safety and their participation in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042977

Principal Investigator: | Dr. Lawrence A Leiter, MD | Division of Endocrinology & Metabolism, St Michael's Hospital |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01042977 History of Changes |
Other Study ID Numbers: |
D1690C00019 |
First Posted: | January 6, 2010 Key Record Dates |
Results First Posted: | August 23, 2013 |
Last Update Posted: | February 17, 2014 |
Last Verified: | December 2013 |
Keywords provided by AstraZeneca:
dapagliflozin diabetes cardiovascular disease |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Cardiovascular Diseases |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |