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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02993614




Registration number
NCT02993614
Ethics application status
Date submitted
13/12/2016
Date registered
13/12/2016
Date last updated
6/02/2019

Titles & IDs
Public title
Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors
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
Secondary ID [1] 0 0
D1690R00015
Universal Trial Number (UTN)
Trial acronym
CVD-REAL
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CVD REAL1 Incidence of hospitalization for heart failure. / CVD REAL 2 All-cause mortality - 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
Timepoint [1] 0 0
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)
Secondary outcome [1] 0 0
CVD REAL1 All-cause mortality; CVD REAL 2: Hospitalization for heart failure (HHF), stroke, myocardial infarction (MI) and including composite endpoints - 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
Timepoint [1] 0 0
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)

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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with a T1DM diagnosis

- Patients with gestational diabetes within 1 year before index date

Study design
Purpose
Duration
Selection
Timing
Prospective
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)
D1690r0001
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Delaware
Country [2] 0 0
Canada
State/province [2] 0 0
D1690r00015
Country [3] 0 0
Denmark
State/province [3] 0 0
D1690r00015
Country [4] 0 0
Finland
State/province [4] 0 0
D1690r00015
Country [5] 0 0
Germany
State/province [5] 0 0
D1690r00015
Country [6] 0 0
Israel
State/province [6] 0 0
D1690r00015
Country [7] 0 0
Italy
State/province [7] 0 0
D1690r00015
Country [8] 0 0
Japan
State/province [8] 0 0
D1690r00015
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
D1690r00015
Country [10] 0 0
Norway
State/province [10] 0 0
D1690r00015
Country [11] 0 0
Portugal
State/province [11] 0 0
D1690r00015
Country [12] 0 0
Singapore
State/province [12] 0 0
D1690r00015
Country [13] 0 0
Spain
State/province [13] 0 0
D1690r00015
Country [14] 0 0
Sweden
State/province [14] 0 0
D1690r00015
Country [15] 0 0
Taiwan
State/province [15] 0 0
D1690r00015
Country [16] 0 0
United Kingdom
State/province [16] 0 0
D1690r00015

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02993614
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No data has been provided for results reporting
Summary results
Other publications