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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02993614
Registration number
NCT02993614
Ethics application status
Date submitted
13/12/2016
Date registered
15/12/2016
Date last updated
18/02/2021
Titles & IDs
Public title
Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors
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Scientific title
Characteristics and Cardiovascular and Mortality Outcomes in Patients With Type 2 Diabetes Mellitus Initiating Treatment With Sodium-glucose Co-transporter-2 Inhibitors (SGLT-2i) and Other Glucose Lowering Drugs
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Secondary ID [1]
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D1690R00015
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Universal Trial Number (UTN)
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Trial acronym
CVD-REAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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CVD REAL1 Incidence of hospitalization for heart failure. / CVD REAL 2 All-cause mortality
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Assessment method [1]
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Heart failure events obtained from general practice or hospital records, electronic health records or national health registers; All-cause mortality obtained from linkeage to death national registers
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Timepoint [1]
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From index date up to latest available data of first prescription of an SGLT-2i or a new oGLD in each of the countries ranging from Sep 11 (UK) until Apr 15 (IL) until the last date of data collection or outcome ranging from Sep 15 (US) to Nov 17 (SG)
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Secondary outcome [1]
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CVD REAL1 All-cause mortality; CVD REAL 2: Hospitalization for heart failure (HHF), stroke, myocardial infarction (MI) and including composite endpoints
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Assessment method [1]
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Events obtained from general practice or hospital records, electronic health records and national health registers. All cause mortality obtained from linkeage to death national registers
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Timepoint [1]
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From index date up to latest available data of first prescription of an SGLT-2i or a new oGLD in each of the countries ranging from Sep 11 (UK) until Apr 15 (IL) until the last date of data collection or outcome ranging from Sep 15 (US) to Nov 17 (SG)
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Eligibility
Key inclusion criteria
- New user receiving or dispensed prescription of SGLT-2i medication or other glucose
lowering drug, oral as well as injectable, including fixed-dose combination (FDC)
products containing these medication groups
- T2DM diagnosis on or prior to the index date
- = 18 years old at index date
- > 1 year data history in the database prior to the index date
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with a T1DM diagnosis
- Patients with gestational diabetes within 1 year before index date
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/12/2020
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Sample size
Target
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Accrual to date
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Final
99999
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Recruitment in Australia
Recruitment state(s)
D1690r0001
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Recruitment hospital [1]
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Research Site - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Delaware
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Canada
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State/province [2]
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D1690r00015
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Denmark
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State/province [3]
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D1690r00015
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Finland
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D1690r00015
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Germany
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D1690r00015
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Israel
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State/province [6]
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D1690r00015
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Italy
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State/province [7]
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D1690r00015
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Country [8]
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Japan
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State/province [8]
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D1690r00015
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Country [9]
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Korea, Republic of
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State/province [9]
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D1690r00015
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Norway
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State/province [10]
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D1690r00015
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Portugal
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State/province [11]
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D1690r00015
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Country [12]
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Singapore
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State/province [12]
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D1690r00015
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Country [13]
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Spain
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State/province [13]
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D1690r00015
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Country [14]
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Sweden
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State/province [14]
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D1690r00015
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Country [15]
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Taiwan
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State/province [15]
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D1690r00015
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Country [16]
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United Kingdom
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State/province [16]
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D1690r00015
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
CVD-REAL is a multinational, observational cohort study in patients with type 2 diabetes
mellitus evaluating the comparative effectiveness of initiating treatment with a
sodium-glucose co-transporter-2 (SGLT-2) inhibitor versus another glucose-lowering drug. This
study will compare the risk of all-cause mortality and clinically relevant cardiovascular
(CV) outcomes respectively in patients who are new users of SGLT-2 inhibitors with those who
are new users of other glucose-lowering drugs. CVD-REAL is aiming to collect data from
approximately 4 million patients overall, from twelve countries across three major world
regions.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02993614
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02993614
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