Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes: a Multicenter Cohort Study

Registration

Registration

NCT04017221

Study type

OBSERVATIONAL

Status

COMPLETED

Enrollment

1249636

Start

2018-10-01

Primary completion

2019-12-01

Lead sponsor

Canadian Network for Observational Drug Effect Studies, CNODES

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

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• Incidence rate of urosepsis [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) [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 [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.]