Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients with Type 2 Diabetes
Launched by CANADIAN NETWORK FOR OBSERVATIONAL DRUG EFFECT STUDIES, CNODES · Jul 11, 2019
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
The objective 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 (DKA) and lower extremity amputation.
A common-protocol approach will be used to conduct retrospective cohort studies using administrative health care data from seven Canadian provinces (Alberta, British Co...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients who newly initiated a SGLT2 inhibitor or DPP-4 inhibitor between January 1, 2013 and June 30, 2018 (or latest date of data availability at each site)
- Exclusion Criteria:
- • Patients aged less than 18 years at cohort entry date (\<66 years in Ontario)
- • Patients with less than 365 days of health care coverage prior to cohort entry
- • Patients with a hospitalization for urinary tract infection or acute pyelonephritis in the 30 days prior to cohort entry (for urosepsis study cohort only)
- • Patients with spinal cord injuries affecting the bladder (for urosepsis study cohort only)
- • Patients with long-term urinary catheter use (for urosepsis study cohort only)
- • Patients with a hospitalization for DKA in the year prior to cohort entry (for DKA study cohort only)
- • Patients with a history of lower extremity amputation at any time prior to cohort entry (for lower extremity amputation study cohort only)
About Canadian Network For Observational Drug Effect Studies, Cnodes
The Canadian Network for Observational Drug Effect Studies (CNODES) is a collaborative research initiative dedicated to advancing the understanding of drug effects through observational studies in real-world settings. By leveraging extensive health databases across Canada, CNODES aims to provide robust evidence on the safety and effectiveness of medications, ultimately informing clinical practice and health policy. The network brings together a diverse team of researchers, clinicians, and data scientists, fostering innovative methodologies and promoting transparency in drug evaluation to enhance patient care and public health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montreal, Quebec, Canada
Patients applied
Trial Officials
Pierre Ernst, MD, MSc, FRCPC
Principal Investigator
Lady Davis Institute for Medical Research, Jewish General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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