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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01042977
Other study ID # D1690C00019
Secondary ID
Status Completed
Phase Phase 3
First received January 5, 2010
Last updated December 18, 2013
Start date March 2010
Est. completion date December 2012

Study information

Verified date December 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 964
Est. completion date December 2012
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
Placebo
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Locations

Country Name City State
Argentina Research Site Buenos Aires Caba
Argentina Research Site Cordoba
Argentina Research Site Rosario Santa Fe
Argentina Research Site Salta
Argentina Research Site Santa Fe
Australia Research Site Adelaide South Australia
Australia Research Site Bedford Park South Australia
Australia Research Site Blacktown New South Wales
Australia Research Site Box Hill Victoria
Australia Research Site Broadmeadow New South Wales
Australia Research Site Carina Heights Queensland
Australia Research Site Heidelberg Victoria
Australia Research Site Herston
Australia Research Site Hornsby New South Wales
Australia Research Site Keswick South Australia
Australia Research Site Kippa-ring Queensland
Australia Research Site Wollongong New South Wales
Austria Research Site Wien
Bulgaria Research Site 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
Canada Research Site Bay Roberts Newfoundland and Labrador
Canada Research Site Calgary Alberta
Canada Research Site Edmonton Alberta
Canada Research Site Etobicoke Ontario
Canada Research Site Halifax Nova Scotia
Canada Research Site Mirabel Quebec
Canada Research Site Moncton New Brunswick
Canada Research Site Ottawa Ontario
Canada Research Site Quebec
Canada Research Site Scarborough Ontario
Canada Research Site Thornhill Ontario
Canada Research Site Toronto Ontario
Chile Research Site Santiago Region Metropolitana
Germany Research Site Damme
Germany Research Site Dortmund
Germany Research Site Homburg
Germany Research Site Munster
Germany Research Site Wangen
Hungary Research Site 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
Poland Research Site 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
United States Research Site Alexandria Virginia
United States Research Site Alexandria Louisiana
United States Research Site Altoona Pennsylvania
United States Research Site Anaheim California
United States Research Site Asheboro North Carolina
United States Research Site Austin Texas
United States Research Site Aventura Florida
United States Research Site Avon Indiana
United States Research Site Bell Gardens California
United States Research Site Berlin New Jersey
United States Research Site Billings Montana
United States Research Site Birmingham Alabama
United States Research Site Boca Raton Florida
United States Research Site Bradenton Florida
United States Research Site Brick New Jersey
United States Research Site Brooksville Florida
United States Research Site Chino California
United States Research Site Chula Vista California
United States Research Site Cincinnati Ohio
United States Research Site Clearwater Florida
United States Research Site Corpus Christi Texas
United States Research Site Dallas Texas
United States Research Site Dania Florida
United States Research Site Delray Beach Florida
United States Research Site Erie Pennsylvania
United States Research Site Fargo North Dakota
United States Research Site Franklin Indiana
United States Research Site Greenfield Indiana
United States Research Site Holland Pennsylvania
United States Research Site Huntington Beach California
United States Research Site Irving Texas
United States Research Site Kalamazoo Michigan
United States Research Site Lancaster Pennsylvania
United States Research Site Livonia Michigan
United States Research Site Los Angeles California
United States Research Site Manassas Virginia
United States Research Site Media Pennsylvania
United States Research Site Mission Hills California
United States Research Site Muncie Indiana
United States Research Site New Smyrna Beach Florida
United States Research Site Oklahoma City Oklahoma
United States Research Site Orlando Florida
United States Research Site Paducah Kentucky
United States Research Site Philadelphia Pennsylvania
United States Research Site Redondo Beach California
United States Research Site Richardson Texas
United States Research Site Riverside California
United States Research Site Rockville Maryland
United States Research Site Sacramento California
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site Scottsdale Arizona
United States Research Site Springfield Illinois
United States Research Site Sugarland Texas
United States Research Site Topeka Kansas
United States Research Site Torrance California
United States Research Site Waterloo Iowa

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Bulgaria,  Canada,  Chile,  Germany,  Hungary,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adjusted Mean Change in HbA1c Levels 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 No
Primary Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit 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 No
Secondary Adjusted Mean Percent Change in Body Weight To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo. Baseline to Week 24 No
Secondary Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI =27 kg/m² 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 No
Secondary Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) 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 No
Secondary Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF) 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 No
Secondary Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg 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 No
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