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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01042977




Registration number
NCT01042977
Ethics application status
Date submitted
5/01/2010
Date registered
6/01/2010
Date last updated
17/02/2014

Titles & IDs
Public title
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
Scientific 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
Secondary ID [1] 0 0
D1690C00019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Cardiovascular Disease 0 0
Inadequate Glycaemic Control 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin
Treatment: Drugs - Placebo

Experimental: 1 - dapagliflozin 10 mg tablet

Placebo Comparator: 2 - matching placebo tablet


Treatment: Drugs: Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period

Treatment: Drugs: Placebo
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Week 24
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline to Week 8
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline to Week 8

Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus.

- Cardiovascular disease

- Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Blacktown
Recruitment hospital [2] 0 0
Research Site - Broadmeadow
Recruitment hospital [3] 0 0
Research Site - Hornsby
Recruitment hospital [4] 0 0
Research Site - Wollongong
Recruitment hospital [5] 0 0
Research Site - Carina Heights
Recruitment hospital [6] 0 0
Research Site - Kippa-ring
Recruitment hospital [7] 0 0
Research Site - Adelaide
Recruitment hospital [8] 0 0
Research Site - Bedford Park
Recruitment hospital [9] 0 0
Research Site - Keswick
Recruitment hospital [10] 0 0
Research Site - Box Hill
Recruitment hospital [11] 0 0
Research Site - Heidelberg
Recruitment hospital [12] 0 0
Research Site - Herston
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Broadmeadow
Recruitment postcode(s) [3] 0 0
- Hornsby
Recruitment postcode(s) [4] 0 0
- Wollongong
Recruitment postcode(s) [5] 0 0
- Carina Heights
Recruitment postcode(s) [6] 0 0
- Kippa-ring
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- Bedford Park
Recruitment postcode(s) [9] 0 0
- Keswick
Recruitment postcode(s) [10] 0 0
- Box Hill
Recruitment postcode(s) [11] 0 0
- Heidelberg
Recruitment postcode(s) [12] 0 0
- Herston
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Florida
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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Montana
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New Jersey
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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Texas
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Virginia
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Argentina
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Caba
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Argentina
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Salta
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Austria
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Wien
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pernik
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Bulgaria
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Pleven
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Bulgaria
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Russe
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Bulgaria
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Sevlievo
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Canada
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Chile
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Germany
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Damme
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Germany
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Dortmund
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Germany
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Homburg
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Germany
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Munster
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Germany
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Wangen
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Hungary
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Ajka
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Balatonfured
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Esztergom
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Gyor
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Komarom
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Mosonmagyarovar
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TAT
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Hungary
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Veszprem
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Bialystok
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Chrzanow
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Gdansk
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Grodzisk Mazowiecki
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Ilawa
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Kielce
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Krakow
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Leczna
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Leczyca
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Lodz
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Lublin
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Mragowo
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Nowy Sacz
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Plock
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Poznan
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Ruda Slaska
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Skierniewice
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Sopot
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Tarnow
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Torun
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Warszawa
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Wroclaw
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Zabrze
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Zgierz
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Poland
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Zielona Gora

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/show/NCT01042977
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Lawrence A Leiter, MD
Address 0 0
Division of Endocrinology & Metabolism, St Michael's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications