NCT02993614

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99,999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
17 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

December 13, 2016

Last Update Submit

February 17, 2021

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (1)

  • CVD REAL1 All-cause mortality; CVD REAL 2: Hospitalization for heart failure (HHF), stroke, myocardial infarction (MI) and including composite endpoints

    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 Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

New users of SGLT--2i and other glucose lowering drugs respectively

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Research Site

Wilmington, Delaware, 19850, United States

Location

Research Site

Melbourne, D1690r00015, Australia

Location

Research Site

Mississauga, D1690r00015, Canada

Location

Research Site

Gentofte Municipality, D1690r00015, Denmark

Location

Research Site

Espoo, D1690r00015, Finland

Location

Research Site

Ulm, D1690r00015, Germany

Location

Research Site

Raanana, D1690r00015, Israel

Location

Research Site

Rome, D1690r00015, Italy

Location

Research Site

Tokyo, D1690r00015, Japan

Location

Research Site

Oslo, D1690r00015, Norway

Location

Research Site

Porto, D1690r00015, Portugal

Location

Research Site

Singapore, D1690r00015, Singapore

Location

Research Site

Seoul, D1690r00015, South Korea

Location

Research Site

Madrid, D1690r00015, Spain

Location

Research Site

Södertälje, D1690r00015, Sweden

Location

Research Site

Taipei, D1690r00015, Taiwan

Location

Research Site

Luton, D1690r00015, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 34332558DERIVED

  • 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.

    PMID: 31410779DERIVED

  • 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.

    PMID: 29852973DERIVED

  • 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.

    PMID: 29540325DERIVED

  • 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.

    PMID: 28522450DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 15, 2016

Study Start

November 30, 2017

Primary Completion

December 17, 2020

Study Completion

December 17, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

FI(1)PT(1)CA(1)GB(1)US(1)KR(1)AU(1)SE(1)DK(1)TW(1)JP(1)DE(1)SG(1)ES(1)IL(1)IT(1)NO(1)