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Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients with Type 2 Diabetes

NCT04017221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1249636

Last updated 2024-09-19

No results posted yet for this study

Summary

The purpose of this study is to compare the risk of serious adverse 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. More specifically, the investigators will assess the risk of severe urinary tract infection (urosepsis), diabetic ketoacidosis and lower extremity amputation. The investigators hypothesize that the use of SGLT2 inhibitors will be associated with an increased risk of serious adverse events in comparison with the use of DPP-4 inhibitors.

The investigators will carry out separate population-based cohort studies using health care databases in seven Canadian provinces and the United Kingdom. Separate study cohorts will be created for each of the three safety outcomes. The study cohorts 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 an adverse event. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of serious adverse events in users of SGLT2 inhibitors in comparison to users of DPP-4 inhibitors.

Conditions

Interventions

DRUG

Sodium-glucose cotransporter 2 (SGLT2) inhibitors

Current exposure to SGLT2 will be defined as a prescription for a SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) alone or in combination with other antidiabetic drugs, excluding DPP-4 inhibitors and insulin.

DRUG

Dipeptidyl peptidase-4 (DPP-4) inhibitors

Current 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 other antidiabetic drugs, excluding SGLT2 inhibitors and insulin.

DRUG

Other treatment combinations

Current exposure to other treatment combinations will be defined as a prescription of other antidiabetic drugs (metformin, sulfonylureas, thiazolidinediones, GLP-1 receptor agonists, alpha-glucosidase inhibitors, meglitinides, insulin, or combinations of these drugs), current use of insulin (alone or combination with other antidiabetic drugs), and non-current use of antidiabetic drugs.

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
2019-12-01
Completion
2019-12-01

Countries

  • Canada

Study Locations

More Related Trials

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 NCT04017221 on ClinicalTrials.gov