Status:
COMPLETED
Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients with Type 2 Diabetes
Lead Sponsor:
Canadian Network for Observational Drug Effect Studies, CNODES
Collaborating Sponsors:
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Conditions:
Diabetes Mellitus, Type 2
Urosepsis
Eligibility:
All Genders
18+ years
Brief 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 peptida...
Detailed Description
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 pepti...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
1249636 Patients enrolled
Trial Details
Trial ID
NCT04017221
Start Date
October 1 2018
End Date
December 1 2019
Last Update
September 19 2024
Active Locations (1)
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1
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2