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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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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D1690r00015
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Italy
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D1690r00015
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Japan
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D1690r00015
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Korea, Republic of
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D1690r00015
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Norway
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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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Singapore
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State/province [12]
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D1690r00015
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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/study/NCT02993614
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Trial related presentations / publications
Khunti K, Kosiborod M, Kim DJ, Kohsaka S, Lam CSP, Goh SY, Chiang CE, Shaw JE, Cavender MA, Tangri N, Franch-Nadal J, Holl RW, Jorgensen ME, Norhammar A, Eriksson JG, Zaccardi F, Karasik A, Magliano DJ, Thuresson M, Chen H, Wittbrodt E, Bodegard J, Surmont F, Fenici P; CVD-REAL Investigators and Study Group. Cardiovascular outcomes with sodium-glucose cotransporter-2 inhibitors vs other glucose-lowering drugs in 13 countries across three continents: analysis of CVD-REAL data. Cardiovasc Diabetol. 2021 Jul 31;20(1):159. doi: 10.1186/s12933-021-01345-z. Nicolucci A, Candido R, Cucinotta D, Graziano G, Rocca A, Rossi MC, Tuccinardi F, Manicardi V. Generalizability of Cardiovascular Safety Trials on SGLT2 Inhibitors to the Real World: Implications for Clinical Practice. Adv Ther. 2019 Oct;36(10):2895-2909. doi: 10.1007/s12325-019-01043-z. Epub 2019 Aug 13. Cavender MA, Norhammar A, Birkeland KI, Jorgensen ME, Wilding JP, Khunti K, Fu AZ, Bodegard J, Blak BT, Wittbrodt E, Thuresson M, Fenici P, Hammar N, Kosiborod M; CVD-REAL Investigators and Study Group. SGLT-2 Inhibitors and Cardiovascular Risk: An Analysis of CVD-REAL. J Am Coll Cardiol. 2018 Jun 5;71(22):2497-2506. doi: 10.1016/j.jacc.2018.01.085. Kosiborod M, Lam CSP, Kohsaka S, Kim DJ, Karasik A, Shaw J, Tangri N, Goh SY, Thuresson M, Chen H, Surmont F, Hammar N, Fenici P; CVD-REAL Investigators and Study Group. Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL 2 Study. J Am Coll Cardiol. 2018 Jun 12;71(23):2628-2639. doi: 10.1016/j.jacc.2018.03.009. Epub 2018 Mar 11. Kosiborod M, Cavender MA, Fu AZ, Wilding JP, Khunti K, Holl RW, Norhammar A, Birkeland KI, Jorgensen ME, Thuresson M, Arya N, Bodegard J, Hammar N, Fenici P; CVD-REAL Investigators and Study Group*. Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors). Circulation. 2017 Jul 18;136(3):249-259. doi: 10.1161/CIRCULATIONAHA.117.029190. Epub 2017 May 18.
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02993614
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