NCT02993614: CVD-REAL

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

Completed Last updated 18 February 2021

What this trial tests

trial in Diabetes Mellitus Type 2 in 99,999 participants. Completed in 17 December 2020.

Timeline

30 November 2017

Primary endpoint
17 December 2020

17 December 2020

Quick facts

Lead sponsor	AstraZeneca
Status	Completed
Study type	OBSERVATIONAL
Enrollment	99,999
Start date	30 November 2017
Primary completion	17 December 2020
Estimated completion	17 December 2020
Sites	17 locations across Denmark, Italy, Finland, Japan, Sweden, Taiwan, United Kingdom, Germany

Conditions studied

• Diabetes Mellitus Type 2 — all drugs for Diabetes Mellitus Type 2 →

Sponsor

AstraZeneca — full company profile →

Who can join

Eligibility, any sex, with Diabetes Mellitus Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Kosiborod M, Cavender MA, Fu AZ, Wilding JP, et al · · 2017 · cited 578× · PMID 28522450 · DOI 10.1161/circulationaha.117.029190
2. Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL 2 Study.
   Kosiborod M, Lam CSP, Kohsaka S, Kim DJ, et al · · 2018 · cited 325× · PMID 29540325 · DOI 10.1016/j.jacc.2018.03.009
3. SGLT-2 Inhibitors and Cardiovascular Risk: An Analysis of CVD-REAL.
   Cavender MA, Norhammar A, Birkeland KI, Jørgensen ME, et al · · 2018 · cited 86× · PMID 29852973 · DOI 10.1016/j.jacc.2018.01.085
4. Cardiovascular Safety, Long-Term Noncardiovascular Safety, and Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Systemic Review and Meta-Analysis With Trial Sequential Analysis.
   Zhang XL, Zhu QQ, Chen YH, Li XL, et al · · 2018 · cited 85× · PMID 29353233 · DOI 10.1161/jaha.117.007165
5. Cardiovascular outcomes with sodium-glucose cotransporter-2 inhibitors vs other glucose-lowering drugs in 13 countries across three continents: analysis of CVD-REAL data.
   Khunti K, Kosiborod M, Kim DJ, Kohsaka S, et al · · 2021 · cited 20× · PMID 34332558 · DOI 10.1186/s12933-021-01345-z
6. Cardiovascular and mortality benefits of sodium-glucose co-transporter-2 inhibitors in patients with type 2 diabetes mellitus: CVD-Real Catalonia.
   Real J, Vlacho B, Ortega E, Vallés JA, et al · · 2021 · cited 19× · PMID 34243779 · DOI 10.1186/s12933-021-01323-5
7. 53 <sup>rd</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Lisbon, Portugal, 11 - 15 September 2017.
   · 2017 · cited 17× · PMID 28795195 · DOI 10.1007/s00125-017-4350-z
8. Cardiorenal Syndrome in Type 2 Diabetes Mellitus - Rational Use of Sodium-glucose Cotransporter-2 Inhibitors.
   Kalra S, Aydin H, Sahay M, Ghosh S, et al · · 2020 · cited 9× · PMID 33117442 · DOI 10.17925/ee.2020.16.2.113