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Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors and Risk of Cardiovascular Events

NCT03939624 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 419734

Last updated 2024-09-19

No results posted yet for this study

Summary

The purpose of this study is to compare the risk of cardiovascular events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes.

The investigators will carry out separate population-based cohort studies using health care databases in seven Canadian provinces and the United Kingdom. The study cohort will be defined by the initiation of a SGLT2 inhibitor or a DPP-4 inhibitor after SGLT2 inhibitors entered the market. Patients will be followed up until the occurrence of a cardiovascular event. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of cardiovascular events in users of SGLT2 inhibitors.

The investigators hypothesize that the use of SGLT2 inhibitors will be associated with a decreased risk of cardiovascular events in comparison with the use of DPP-4 inhibitors.

Conditions

Interventions

DRUG

Sodium-glucose cotransporter 2 (SGLT2) inhibitors

Exposure to SGLT2 will be defined as a prescription for a SGLT2 inhibitor alone (canagliflozin, dapagliflozin, empagliflozin) or in combination with non-DPP4 inhibitor drugs at cohort entry date.

DRUG

Dipeptidyl peptidase-4 (DPP-4) inhibitors

Exposure to DPP-4 will be defined as a prescription for a DPP-4 inhibitor (alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin) alone or in combination with non-SGLT2 inhibitor drugs at cohort entry date.

Sponsors & Collaborators

  • Drug Safety and Effectiveness Network, Canada

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Network for Observational Drug Effect Studies, CNODES

    lead OTHER

Principal Investigators

  • Pierre Ernst, MD, MSc, FRCPC · Lady Davis Institute for Medical Research, Jewish General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03939624 on ClinicalTrials.gov