Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study

2193/2018

GIOIA represents a multicenter pragmatic prospective cohort study, aimed at evaluating the effects of SGLT2 inhibitors currently marketed (dapagliflozin, canagliflozin, empagliflozin) on markers of vascular, myocardial and renal damage, in patients with type 2 diabetes not well controlled with metformin and/or basal insulin. The changes of the interest outcomes are compared with those obtained with a comparator glucose lowering class (DPP-4inhibitors) over a follow-up of two years.

2018-01-15

2023-12-31

2023-12-31

Completed

1150

Inclusion Criteria: * type 2 diabetes for at least 5 years * new use of an SGLT2-I or DPP4-I as add-on to metformin or insulin according to clinical practice * HbA1c levels ≥ 7% and ≤ 8.5% * eGFR ≥ 60 ml/min/1.73 m2 Exclusion Criteria: * Type 1 diabetes or secondary diabetes resulting from specific causes * History of neurovascular ulcers * Previous therapy with SGLT-2i or DPP4-i in the 3 months prior to the study enrollment * History of cancer within the last 5 years * Pregnancy or active breast-feeding * Serum creatinine level ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men * eGFR ≤ 60 ml/min/1.73 m2

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1150, 'type': 'ACTUAL'}}

2024-04-19