Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors

Completed

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT02993614

Run by

AstraZeneca

People needed

99999

Starts

2017-11-30

Expected to finish

2020-12-17

Last updated by the study team

2021-02-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with a T1DM diagnosis
• Patients with gestational diabetes within 1 year before index date

Where it is running

• Research Site — Wilmington, Delaware, United States
• Research Site — Melbourne, D1690r00015, Australia
• Research Site — Mississauga, D1690r00015, Canada
• Research Site — Gentofte Municipality, D1690r00015, Denmark
• Research Site — Espoo, D1690r00015, Finland
• Research Site — Ulm, D1690r00015, Germany
• Research Site — Raanana, D1690r00015, Israel
• Research Site — Rome, D1690r00015, Italy
• Research Site — Tokyo, D1690r00015, Japan
• Research Site — Oslo, D1690r00015, Norway
• Research Site — Porto, D1690r00015, Portugal
• Research Site — Singapore, D1690r00015, Singapore
• Research Site — Seoul, D1690r00015, South Korea
• Research Site — Madrid, D1690r00015, Spain
• Research Site — Södertälje, D1690r00015, Sweden
• Research Site — Taipei, D1690r00015, Taiwan
• Research Site — Luton, D1690r00015, United Kingdom

Full record on ClinicalTrials.gov

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