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

September 24, 2013 updated by: AstraZeneca

A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients 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, cardiovascular disease and hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

922

Phase

  • 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
      • Buenos Aires, Argentina
        • Research Site
      • Caba, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina
        • Research Site
    • Caba
      • Buenos Aires, Caba, Argentina
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • British Columbia
      • New Westminster, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • Carbonear, Newfoundland and Labrador, Canada
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • Courtice, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Smiths Falls, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Lachine, Quebec, Canada
        • Research Site
      • Laval, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Saint-marc-des-carrieres, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
  • Germany
      • Bad Nauheim, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Erdmannhausen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Heilbronn, Germany
        • Research Site
      • Hildesheim, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Speyer, Germany
        • Research Site
      • Wahlstedt, Germany
        • Research Site
    • BR
      • Potsdam, BR, Germany
        • Research Site
  • Romania
      • Braila, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Constanta, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Sibiu, Romania
        • Research Site
      • Suceava, Romania
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Dolny Kubin, Slovakia
        • Research Site
      • Komarno, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Kysucke Nove Mesto, Slovakia
        • Research Site
      • Liptovsky Hradok, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Prievidza, Slovakia
        • Research Site
      • Rimavska Sobota, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
  • Spain
    • Andalucia
      • Cordoba, Andalucia, Spain
        • Research Site
      • Granada, Andalucia, Spain
        • Research Site
      • Sevilla, Andalucia, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
      • Lerida, Cataluna, Spain
        • Research Site
      • Olot (girona), Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • San Juan (alicante), Comunidad Valenciana, Spain
        • Research Site
      • Valencia, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Majadahonda, Comunidad de Madrid, Spain
        • Research Site
    • Galicia
      • A Coruna, Galicia, Spain
        • Research Site
      • Santiago de Compostela, Galicia, Spain
        • Research Site
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan County, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-yuan, Taiwan
        • Research Site
  • United States
    • Alabama
      • Gulf Shores, Alabama, United States
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • Burbank, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • Huntington Park, California, United States
        • Research Site
      • Lancaster, California, United States
        • Research Site
      • Salinas, California, United States
        • Research Site
      • San Marino, California, United States
        • Research Site
      • San Ramon, California, United States
        • Research Site
      • Tustin, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States
        • Research Site
    • Florida
      • Clearwater, Florida, United States
        • Research Site
      • Deerfield Beach, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Hollywood, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Port Charlotte, Florida, United States
        • Research Site
      • Port Orange, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Georgia
      • Columbus, Georgia, United States
        • Research Site
      • Decatur, Georgia, United States
        • Research Site
      • Stone Mountain, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
      • Lake Charles, Louisiana, United States
        • Research Site
      • West Monroe, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States
        • Research Site
      • St Louis, Missouri, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Brick, New Jersey, United States
        • Research Site
      • Oradell, New Jersey, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
      • New Hyde Park, New York, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Phoenixville, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Reading, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Kingsport, Tennessee, United States
        • Research Site
    • Texas
      • Carrollton, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Fort Worth, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • North Richland Hills, Texas, United States
        • Research Site
      • Plano, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Tomball, Texas, United States
        • Research Site
    • Utah
      • Ogden, Utah, United States
        • Research Site
    • Virginia
      • Danville, Virginia, United States
        • Research Site
    • Washington
      • Spokane, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh, Vietnam
        • 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

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
  • Hypertension

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Matching placebo tablet
Drug: Placebo
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Experimental: 1
Dapagliflozin 10 mg tablet
Drug: Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period

What is the study measuring?

Primary Outcome Measures

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 and hypertension, 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 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.
Baseline to week 24

Secondary Outcome Measures

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 Seated Systolic Blood Pressure (SBP)
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 (SBP) 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

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Dr. William Cefalu, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 11, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690C00018

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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