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

December 18, 2013 updated by: AstraZeneca

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

This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
964

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina
        • Research Site
      • Salta, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
    • Caba
      • Buenos Aires, Caba, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
  • Australia
      • Herston, Australia
        • Research Site
    • New South Wales
      • Blacktown, New South Wales, Australia
        • Research Site
      • Broadmeadow, New South Wales, Australia
        • Research Site
      • Hornsby, New South Wales, Australia
        • Research Site
      • Wollongong, New South Wales, Australia
        • Research Site
    • Queensland
      • Carina Heights, Queensland, Australia
        • Research Site
      • Kippa-ring, Queensland, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
      • Bedford Park, South Australia, Australia
        • Research Site
      • Keswick, South Australia, Australia
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia
        • Research Site
      • Heidelberg, Victoria, Australia
        • Research Site
  • Austria
      • Wien, Austria
        • Research Site
  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Research Site
      • Pernik, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Russe, Bulgaria
        • Research Site
      • Sevlievo, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Etobicoke, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
      • Thornhill, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Mirabel, Quebec, Canada
        • Research Site
  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Research Site
  • Germany
      • Damme, Germany
        • Research Site
      • Dortmund, Germany
        • Research Site
      • Homburg, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
  • Hungary
      • Ajka, Hungary
        • Research Site
      • Balatonfured, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Esztergom, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Komarom, Hungary
        • Research Site
      • Mosonmagyarovar, Hungary
        • Research Site
      • TAT, Hungary
        • Research Site
      • Veszprem, Hungary
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Chrzanow, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Grodzisk Mazowiecki, Poland
        • Research Site
      • Ilawa, Poland
        • Research Site
      • Kielce, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Leczna, Poland
        • Research Site
      • Leczyca, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Mragowo, Poland
        • Research Site
      • Nowy Sacz, Poland
        • Research Site
      • Plock, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Ruda Slaska, Poland
        • Research Site
      • Skierniewice, Poland
        • Research Site
      • Sopot, Poland
        • Research Site
      • Tarnow, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
      • Zgierz, Poland
        • Research Site
      • Zielona Gora, Poland
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Bell Gardens, California, United States
        • Research Site
      • Chino, California, United States
        • Research Site
      • Chula Vista, California, United States
        • Research Site
      • Huntington Beach, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Mission Hills, California, United States
        • Research Site
      • Redondo Beach, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Florida
      • Aventura, Florida, United States
        • Research Site
      • Boca Raton, Florida, United States
        • Research Site
      • Bradenton, Florida, United States
        • Research Site
      • Brooksville, Florida, United States
        • Research Site
      • Clearwater, Florida, United States
        • Research Site
      • Dania, Florida, United States
        • Research Site
      • Delray Beach, Florida, United States
        • Research Site
      • New Smyrna Beach, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
    • Illinois
      • Springfield, Illinois, United States
        • Research Site
    • Indiana
      • Avon, Indiana, United States
        • Research Site
      • Franklin, Indiana, United States
        • Research Site
      • Greenfield, Indiana, United States
        • Research Site
      • Muncie, Indiana, United States
        • Research Site
    • Iowa
      • Waterloo, Iowa, United States
        • Research Site
    • Kansas
      • Topeka, Kansas, United States
        • Research Site
    • Kentucky
      • Paducah, Kentucky, United States
        • Research Site
    • Louisiana
      • Alexandria, Louisiana, United States
        • Research Site
    • Maryland
      • Rockville, Maryland, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
      • Livonia, Michigan, United States
        • Research Site
    • Montana
      • Billings, Montana, United States
        • Research Site
    • New Jersey
      • Berlin, New Jersey, United States
        • Research Site
      • Brick, New Jersey, United States
        • Research Site
    • North Carolina
      • Asheboro, North Carolina, United States
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Research Site
      • Erie, Pennsylvania, United States
        • Research Site
      • Holland, Pennsylvania, United States
        • Research Site
      • Lancaster, Pennsylvania, United States
        • Research Site
      • Media, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Corpus Christi, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Irving, Texas, United States
        • Research Site
      • Richardson, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Sugarland, Texas, United States
        • Research Site
    • Virginia
      • Alexandria, Virginia, United States
        • Research Site
      • Manassas, Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
Baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 24
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.
Baseline to Week 24
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.
Baseline to Week 8
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.
Baseline to Week 24
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.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Lawrence A Leiter, MD, Division of Endocrinology & Metabolism, St Michael's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1690C00019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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