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Clinical Trial Details

Trial ID: L4713
Source ID: NCT04017221
Associated Drug: Sodium-Glucose Cotransporter 2 (Sglt2) Inhibitors
Title: Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients with Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Urosepsis|Diabetic Ketoacidosis|Lower Extremity Amputation
Interventions: DRUG: Sodium-glucose cotransporter 2 (SGLT2) inhibitors|DRUG: Dipeptidyl peptidase-4 (DPP-4) inhibitors|DRUG: Other treatment combinations
Outcome Measures: Primary: Incidence rate of urosepsis, Urosepsis will be defined as a hospitalization with a diagnosis of acute pyelonephritis or urinary tract infection with a corresponding code for sepsis, using the following ICD-10-CA codes: * Acute pyelonephritis (ICD-10-CA: N10) or urinary tract infection (ICD-10-CA: N30.0, N39.0) in combination with; * Sepsis (ICD-10-CA: A41.x, R56.2, R57.2)., Patients will be followed from the date of study cohort entry until hospitalization for urosepsis, death, end of health care coverage, or for up to 64 months, whichever occurs first.|Incidence rate of diabetic ketoacidosis (DKA), DKA will be defined as a hospitalization with a primary diagnosis of DKA or visit to the emergency department (in sites where this data is available) using the following ICD-10-CA codes: E11.10, E11.12, E13.10, E13.12., Patients will be followed from the date of study cohort entry until hospitalization for DKA, death, end of health care coverage, or for up to 64 months, whichever occurs first.|Incidence rate of lower extremity amputation, Lower extremity amputation will be defined by procedure codes recorded in the hospital discharge abstract or the physician claims using the following CCI (Canadian Classification of Health Interventions) codes: 1VC93, 1VG93, 1VQ93, 1WA93, 1WE93, 1WI93, 1WJ93, 1WK93, 1WL93, 1WM93, 1WN93., Patients will be followed from the date of study cohort entry until occurrence of a lower extremity amputation, death, end of health care coverage, or for up to 64 months, whichever occurs first. | Secondary: Incidence rate of Fournier's gangrene, Fournier's gangrene will be defined as an inpatient diagnosis using the following ICD-10-CA codes: N49.3, N76.8, N76.88., Patients will be followed from the date of study cohort entry until occurrence of Fournier's gangrene, death, end of health care coverage, or for up to 64 months, whichever occurs first.
Sponsor/Collaborators: Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES | Collaborators: Drug Safety and Effectiveness Network, Canada|Canadian Institutes of Health Research (CIHR)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 1249636
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2018-10-01
Completion Date: 2019-12-01
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, H3T1E2, Canada
URL: https://clinicaltrials.gov/show/NCT04017221